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STUDY DESIGN Retrospective case series. OBJECTIVE The purpose of this study was to report on a large consecutive series of posterolateral fusion cases using rhBMP-2/ACS. SUMMARY OF BACKGROUND DATA Despite evidence that rhBMP-2/ACS is effective as an iliac crest graft substitute in posterolateral fusion, concerns remain regarding potential risk for BMP use in clinical practice. These concerns have been fueled by the serious complications reported with BMP in anterior cervical spine fusion. While none of the literature on posterolateral fusion with rhBMP-2/ACS has suggested an increased complication rate versus iliac crest bone graft, this issue has not been specifically studied. METHODS We reviewed medical records for a consecutive series of 1037 patients who underwent posterolateral spine fusion using rhBMP-2 between 2003 and 2006. Medical complications were attributed to the surgical procedure if they occurred within the 3-month perioperative period, whereas complications potentially related to BMP were included regardless of time frame. RESULTS Medical and surgical complications were observed in 190 of 1037 patients (18.3%) with 81 major complications (7.8%) and 110 minor complications (10.2%). Neurologic complications were related to screw malposition in 6 patients and epidural hematoma in 3 patients. New or more severe postoperative radicular symptoms were noted in 7 patients (0.7%). Psoas hematoma was identified by CT scan in 8 patients (0.8%). Complications directly related to rhBMP-2 were observed in at least 1 patient (0.1%) and in a worst case analysis, in as many as 6 patients (0.6%). CONCLUSION This study in 1037 patients confirms the relative safety of rhBMP-2/ACS for posterolateral spine fusion. There were extremely few complications directly attributed to rhBMP-2/ACS, and the overall complication rates were consistent with established norms. The stark contrast between this experience and the markedly elevated complication rate reported with anterior cervical BMP usage emphasizes the need to evaluate risks and benefits of bioactive technologies in a site-specific and procedure-specific manner.

Object The current standard of care for symptomatic chronic spondylolysis (SP) is a one-level posterior spinal fusion for defects at L-5 or direct pars repair (motion segment sparing) for more rostral SP in younger patients and if no disc degeneration or listhesis is present. Since many patients with SP undergoing operative repair are young, a procedure with the lowest biomechanical profile is desirable, and direct pars repair is recommended. The authors here explore the limits of direct pars repair. Methods A retrospective review of all patients who underwent direct repair of SP between 2002 and 2009 was performed. Data were analyzed for predictors of symptom relief and radiographic fusion failure. Results Of 49 patients, only 7 required a reoperation to treat clinical symptoms, and 6 of them were female (p = 0.049). In all cases of treatment failure, the patient had bilateral L-5 SP. Patients with a slip percentage as high as 30% experienced radiographic fusion and symptom relief. Disc degeneration (measured using the Modified Pfirrmann Scale) did not predict symptom persistence or radiographic fusion failure. Patients with high-grade disc disease experienced symptom relief. The authors found no predictors of treatment failure. Conclusions The number of patients undergoing motion segment–sparing fusions of symptomatic chronic SP can be safely increased to include patients with Grade I spondylolisthesis as well as high-grade disc disease. Female patients with bilateral L-5 SP and low lordotic angles may be better served by a posterior spinal fusion from L-5 to S-1.

Study design Cross sectional. Objective This study presents the factor analysis of the Spinal Appearance Questionnaire (SAQ) and its psychometric properties. Summary of background data Although the SAQ has been administered to a large sample of patients with adolescent idiopathic scoliosis (AIS) treated surgically, its psychometric properties have not been fully evaluated. This study presents the factor analysis and scoring of the SAQ and evaluates its psychometric properties. Methods The SAQ and the Scoliosis Research Society-22 (SRS-22) were administered to AIS patients who were being observed, braced or scheduled for surgery. Standard demographic data and radiographic measures including Lenke type and curve magnitude were also collected. Results Of the 1802 patients, 83% were female; with a mean age of 14.8 years and mean initial Cobb angle of 55.8° (range, 0°-123°). From the 32 items of the SAQ, 15 loaded on two factors with consistent and significant correlations across all Lenke types. There is an Appearance (items 1-10) and an Expectations factor (items 12-15). Responses are summed giving a range of 5 to 50 for the Appearance domain and 5 to 20 for the Expectations domain. The Cronbach's α was 0.88 for both domains and Total score with a test-retest reliability of 0.81 for Appearance and 0.91 for Expectations. Correlations with major curve magnitude were higher for the SAQ Appearance and SAQ Total scores compared to correlations between the SRS Appearance and SRS Total scores. The SAQ and SRS-22 Scores were statistically significantly different in patients who were scheduled for surgery compared to those who were observed or braced. Conclusion The SAQ is a valid measure of self-image in patients with AIS with greater correlation to curve magnitude than SRS Appearance and Total score. It also discriminates between patients who require surgery from those who do not.

Study design Retrospective cohort analysis of prospectively collected data. Objective The purpose of this study is to report health-related quality of life (HRQOL) outcomes in patients 75 years of age and older who underwent one- to two-level instrumented posterolateral lumbar arthrodesis. Summary of background data HRQOL measures are increasingly used to measure clinical success after spinal surgery. There is limited data available to guide the clinician caring for the growing geriatric population with degenerative lumbar spine conditions. Methods From a database of prospectively collected HRQOL measures in patients undergoing instrumented lumbar arthrodesis, we identified 35 patients 75 years of age and older who underwent one- or two-level instrumented posterolateral lumbar arthrodesis who had complete preoperative and 2-year postoperative data. HRQOL measures included the Oswestry Disability Index (ODI), Short Form-36 Physical Component Score (PCS) and Mental Component Score (MCS), and back and leg pain numerical rating scales. Paired sample t tests were used to compare preoperative and 2-year postoperative scores. The percentage of patients reaching previously established thresholds for Minimum Clinically Important Difference (MCID) and Substantial Clinical Benefit (SCB) were calculated. Results There were 11 men and 24 women with a mean age of 78.3 years (range 75-85). Diagnoses included stenosis (20), spondylolisthesis (12), instability (1), disc pathology (1), and scoliosis (1). Twelve patients (34%) had complications, 8 (23%) major and 4 (11%) minor. There was a statistically significant improvement in all of the HRQOL measures from preoperative to 2-years postoperative. Sixty percent (21 of 35) of the patients reached the MCID threshold for ODI, PCS, and leg pain, whereas 83% (29 of 35) reached the MCID for back pain. More than half of the patients reached the SCB threshold for leg pain (19 of 35, 54%), back pain (21 of 35, 60%), ODI (19 of 35, 54%), and PCS (21 of 35, 60%). Conclusions Properly selected patients 75 years of age and older can achieve substantial clinical improvements, based on patient reported HRQOL measures, 2 years after one- and two-level instrumented posterolateral lumbar arthrodesis.

Study design Longitudinal cohort. Objective To determine the minimum clinically important difference (MCID) of the Scoliosis Research Society (SRS)-22 Appearance, Activity, and Pain domains in patients with adolescent idiopathic scoliosis undergoing surgical correction of their spinal deformity. Summary of background data The MCID, a threshold of improvement that is clinically relevant to the individual patient, is increasingly used to evaluate treatment effectiveness. MCID values for the SRS-22 domains have not been determined. Methods Patients with adolescent idiopathic scoliosis who underwent surgical correction and had completed SRS-22 before operation and the SRS-30 and Scoliosis Appearance Questionnaire (SAQ) at 1 year after operation from a multicenter database for pediatric scoliosis were identified. The SAQ is a modification of the Walter Reed Visual Assessment Scale and is used to assess the patient's perception of their spinal deformity. Paired sample t tests were used to compare preoperative and 1-year postoperative scores. Spearman correlations were used to evaluate associations between domain scores and summed responses to anchors for Appearance, Activity, and Pain. MCID values for the SRS-22 domains were determined using receiver operating characteristic curve analysis, with summed responses to anchor questions 23 to 30 of the SRS-30 and items 26 and 32 of the SAQ. Results There were 735 women and 152 men with a mean age of 14.3 years and a mean Cobb angle of 53°. There was a statistically significant difference between paired preoperative and 1-year SRS domain scores. Analysis of variance showed a statistically significant difference between the summed responses to the anchors. The MCID was 0.20 for the Pain domain (area under the curve [AUC] = 0.723), 0.08 for Activity (AUC = 0.648), and 0.98 for Appearance (AUC = 0.629). The MCID for activity was less than the standard error of measurement. Conclusion The MCID for the Pain domain was 0.20 and 0.98 for Appearance. Because these patients were generally in good health, a minimal though significant change in activity was observed, such that the calculated MCID was within the measurement error. As expected, the largest and most important change was in the Appearance domain. Future studies are needed to determine the MCID for the mental domain and the total SRS score and to further validate the MCID values in this study.

Study Design. Systematic review. Objective. To determine whether early spinal stabilization in the multiple trauma patient is safe and does not increase morbidity or mortality. Summary of Background Data. There is no consensus regarding the timing of surgical stabilization of the injured spine, especially in patients with multiple trauma. Designing and performing randomized clinical trials to evaluate early versus late surgery is difficult. Methods. Between January 1990 and July 2009, a computer-aided search using the keywords Spine or Spinal, Trauma, Spinal Cord Injury, and Surgery was done that included MEDLINE, EMBASE, HealthSTAR, Cumulative Index to Nursing and Allied Health Literature, Cochrane Database of Systematic Reviews, ACP Journal Club, Database of Abstracts of Reviews of Effects, Cochrane Central Register of Controlled Trials, PsycINFO, and PsychLit. Articles dealing only with neurologic improvement that did not mention other non-neurologic factors that were affected by early surgery were excluded. The authors selected and assessed the studies to be included in the analysis. An unblinded assessment of the quality of the study was done using the Gradeing of Recommendation, Assessment, Development and Evaluation approach to rank each article for its relevance to the topic. Results. Eleven articles directly comparing 2 cohorts that had early or late surgery were identified. All of the studies evaluated consistently demonstrated shorter hospital and intensive care unit length of stays, fewer days on mechanical ventilation, and lower pulmonary complications in patients who are treated with early spine decompression and stabilization. These advantages are more marked in patients with polytrauma. Data regarding morbidity and mortality rates are more variable. Conclusion. There is strong evidence within the literature that early surgical stabilization consistently leads to shorter hospital stays, shorter intensive care unit stays, less days on mechanical ventilation, and lower pulmonary complications. This effect is more evident in patients who have more severe injuries as measured by Injury Severity Score. This benefit is seen in both, spinal cord injured and noncord-injured patients. There is also some evidence that early stabilization does not increase the complication rates compared to late surgery.

Study design Prospective multicenter database. Objective To identify factors associated with outcomes from adolescent idiopathic scoliosis (AIS) surgery outcomes and especially poor results. Summary of background data Because AIS is rarely symptomatic during adolescence, excellent surgical results are expected. However, some patients have poor outcomes. This study seeks to identify factors correlating with results and especially those making poor outcomes more likely. Methods Demographic, surgical, and radiographic parameters were compared to 2-year postoperative Scoliosis Research Society (SRS) scores in 477 AIS surgical patients using stepwise linear regression to identify factors predictive of 2-year domain and total scores. Poor postoperative score patients (>2 SD below mean) were compared using t tests to those with better results. Results The SRS instrument exhibited a strong ceiling effect. Two-year scores showed more improvement with greater curve correction (self-image, pain, and total), and were worse with larger body mass index (pain, mental, total), larger preoperative trunk shift (mental and total), larger preoperative Cobb (self-image), and preoperative symptoms (function). Poor results were more common in those with Lenke 3 curve pattern (pain), less preoperative coronal imbalance, trunk shift and rib prominence (function), preoperative bracing (self-image), and anterior procedures (mental). Poor results also had slightly less average curve correction (50% vs. 60%) and larger curve residuals (31° vs. 23°). Complications, postoperative curve magnitude, and instrumentation type did not significantly contribute to postoperative scores, and no identifiable factors contributed to satisfaction. Conclusion Curve correction improves patient's self-image whereas pain and poor function before surgery carry over after surgery. Patients with less spinal appearance issues (higher body mass index, Lenke 3 curves) are less happy with their results. Except in surgical patient selection, many of these factors are beyond physician control.

BACKGROUND CONTEXT In 2016 alone, 19,413 deaths were attributed to prescription opioid overdoses. Understanding the drivers of opiate consumption in postoperative lumbar spinal fusion patients is a high priority. PURPOSE To determine if surgical invasiveness and/or preoperative opiate use influences immediate postoperative opiate consumption. STUDY DESIGN/SETTING Propensity matched longitudinal cohort. PATIENT SAMPLE Patients from a multi-surgeon, single spine specialty center with degenerative lumbar pathology who underwent an instrumented posterior lumbar decompression and interbody fusion (MIDLIF or TLIF). OUTCOME MEASURES Oswestry Disability Index, morphine equivalent doses (MED) from postoperative day (POD) #0 through POD #4. METHODS A single-center, multi-surgeon, retrospective review identified patients with degenerative lumbar pathology who underwent an instrumented posterior lumbar decompression and interbody fusion (MIDLIF or TLIF). Patients in each cohort were propensity-matched based on age, sex, smoking status, BMI, diagnosis, ASA grade and levels fused. MED POD #0 through POD #4 were calculated. Preoperative opiate prescriptions were recorded to determine baseline opioid use. RESULTS Of 214 MIDLIF and 281 TLIF patients undergoing surgery, 33 patients in each cohort were successfully propensity matched with no differences in baseline characteristics. There was no difference in immediate postoperative mean total MED between the cohorts (MIDLIF=370, TLIF=302, p=.398). Forty-three (65%) of patients were taking opiates prior to surgery. Opiate-naive patients required less narcotics (MED=248) compared to nonopiate naive patients (MED=383, p=.071) but this was not significant. Patients taking opiates preop had worse baseline ODI (56.5 vs. 47.2, p=.023) and 1-year postop ODI (46.3 vs. 30.9, p=.015). CONCLUSIONS Neither surgical invasiveness nor preoperative opiate use have an impact on immediate postop opiate consumption. This is likely secondary to non-individualized prescribing patterns. Patients taking preop narcotics have worse baseline, 1-year, and improvement in ODI following 1- and 2-level MIDLIFs or TLIFs. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

BACKGROUND CONTEXT Lumbar disc herniation (LDH) is associated with great morbidity and significant socio-economic impact in many parts of the world, as the majority of the patients are of working age. The patients' ability to return to the workforce following an illness depends on the person's workload, strength of social relationships, level of education and length of sick leave. PURPOSE The purpose of this study is to determine if the duration of preoperative sick leave is predictive of return to work following discectomy. STUDY DESIGN/SETTING A retrospective study of prospectively collected data from the Danish Spine database (DaneSpine) and the Danish Ministry of Employment's national register of public sickness benefits (DREAM database). PATIENT SAMPLE The study population comprised of a consecutive cohort of patients aged between 17 and 62years at the time of operation, treated at a single spine specialty center due to LDH during the period from 1 June 2010 to 31 May 2013. All patients had magnetic resonance imaging demonstrating lumbar disc herniation at the level and side corresponding with the patient's symptoms. OUTCOME MEASURES Number of weeks on sick leave post-operatively. METHODS Data available from the DREAM database included weekly public transfer payments to the patients two years prior to the date of operation and two years postoperative. As work force attachment is a cyclically sensitive parameter, a control cohort was also made available. The control cohort was matched to the LDH cases based on date of birth, sex and municipality of residence on the week of surgery. After linking data from DaneSpine and the DREAM register the surgical and vocational record for each person was established. We examined the weekly status of any type of transfer income in each of the weeks two years prior and after the date of surgery to describe the socio-economical history for each person before and after the surgery. RESULTS A total of 1,134 consecutive patients operated due to herniated lumbar disc and 3,402 age and sex matched controls were included in the study. The mean age in both cohorts was 48.16±14.75. One year postoperative the employment rate for cases was fairly constant, at 15 % below the controls. There was a strong association between the duration of preoperative sick leave and postoperative sick leave, with a correlation coefficient of 0.832 (p CONCLUSIONS Denmark has a public and free health care system, which minimizes socio-economic differences in the access to health care, thus reducing the risk of bias in the present study. Due to free health care socio-economic factors should not affect the duration of preoperative sick leave. The study indicated a need to address the patients with sick leave exceeding 3 months due to LDH to avoid long-term sick leave, risk of developing chronic pain syndromes and risk of early retirement.

BACKGROUND CONTEXT It is unclear if patients with recurrent disc herniation (RDH) benefit from a concurrent fusion compared to a repeat decompression alone. No studies are available comparing outcomes of decompression alone (D0) versus decompression and fusion (DF) for RDH. PURPOSE The purpose of the study is to compare clinical outcomes and revisions in patients with first episode recurrent disc herniation treated with decompression only compared to decompression and concommittant fusion. STUDY DESIGN/SETTING Multicenter longitudinal observational cohort. PATIENT SAMPLE Patients enrolled in the Quality Outcomes Database (QOD) from three sites with a first episode of RDH and one- to two-level surgery. OUTCOME MEASURES Numeric rating scales (0–10) for back and leg pain, Oswestry Disability Index (ODI), EuroQOL-5D (EQ-5D), revision surgery. METHODS Patients enrolled in QOD from three sites with a first episode of RDH and one- to two-level surgery were identified. Demographic, surgical and radiographic data including the presence of listhesis and extent of facet resection on CT or MRI prior to the index surgery were collected. Patient Reported Outcomes (PROs), including back and leg pain, ODI and EQ-5D, were collected pre-op and at 3 and 12 months post-op. RESULTS Of 94 cases identified, 55 had D0 and 39 had DF. The patients were similar in age, sex distribution, smoking status, BMI, ASA grade and surgical levels. Presence of listhesis (D0=7, DF=5, p=.800) and extent of facet fusion (D0=19%, DF=16%, p=.309) prior to index surgery were similar between the two groups. EBL (D0=26cc DF=329cc p CONCLUSIONS For a first episode recurrent disc herniation, surgeons can expect similar outcomes whether patients are treated with decompression alone or decompression and fusion. Despite similarities in baseline demographic, PRO and radiologic data, variables that lead a surgeon to choose decompression alone or decompression and fusion are unknown and can lead to selection bias. Further studies are needed to identify clear indications for fusion in patients with first episode recurrent disc herniation.

BACKGROUND CONTEXT Posterior instrumented lumbar fusions are commonly performed utilizing interbody fusions. Recently, a minimally invasive technique of midline exposure with cortical bone trajectory screw fixation has been described (MIDLIF). The goal is to limit muscle dissection, decreasing surgical morbidity and expedite recovery. PURPOSE The purpose of this study was to compare index episode of care (iEOC) cost between patients undergoing MIDLIF versus tTLIF. STUDY DESIGN/SETTING Multi-surgeon single-center spine specialty tertiary practice. PATIENT SAMPLE Consecutive patients undergoing 1- or 2-level MIDLIF or tTLIF for degenerative lumbar conditions were identified. OUTCOME MEASURES Index episode of care cost data for surgical and hospital stay parameters and included actual, direct, hospital cost. METHODS A retrospective review of a prospective, multi-surgeon, surgical database was utilized. Consecutive patients undergoing 1- or 2-level MIDLIF or tTLIF for degenerative lumbar conditions were identified. Patients in each cohort were propensity-matched based on age, sex, smoking status, BMI, diagnosis, ASA grade and levels fused. iEOC cost data was collected for surgical and hospital stay parameters and included actual, direct, hospital cost for the index surgical visit. RESULTS Of 214 and 281 patients undergoing MIDLIF or tTLIF, respectively, 105 cases in each cohort were successfully propensity-matched. Consistent with propensity matching, there was no difference in age, sex, BMI, diagnosis, ASA score, smoking status, or levels fused. Spondylolisthesis was the most common indication for surgery in both cohorts. The mean total iEOC was $706 ($16,604 vs. $17,310) lower for MIDLIF versus tTLIF. There was no difference in implant (p=.193) or biologic (p=.145) cost but blood utilization (p=.000), OR supplies (p=.000), hospital room/board (p=.000), pharmacy (p=.010), and therapy (p=.009) costs were all significantly lower in MIDLIF. Additionally, mean LOS was decreased for MIDLIF (2.97 vs. 4.02, p=.000). CONCLUSIONS Compared to traditional open tTLIF, patients undergoing MIDLIF have several cost parameters of the iEOC that are significantly lower as well as a shorter length of stay. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

BACKGROUND CONTEXT Coccydynia caused by trauma or giving birth is mostly reported in females in the age 30-60years. Many treatment modalities have been suggested including special pillows, steroid injections, special physiotherapy and pain medication. Patients suffering from coccydynia reports severe pain and reduced Health related quality of life. Surgical treatment, can relieve persistent pain in patients suffering from coccydynia.This study reports the outcome, after surgical removal of coccyx in 138 consecutive patients. PURPOSE The purpose of this study is to report the outcome and rate of complications, 1 year after surgical treatment with partial or complete removal of the coccyx. STUDY DESIGN/SETTING A prospective cohort study. PATIENT SAMPLE Patients suffering from persistent coccydynia, for at least 12 months, after a blunt trauma. OUTCOME MEASURES Patient Reported Outcome Measures, SF- 36PCS/MCS, ODI, EQ5D, VAS Back/VAS Leg. METHODS Patients are evaluated by examination with bimanual palpation of the coccyx, and examination of the pelvic ligaments. If abnormal movement is present and the pain mechanism can be activated during examination of the coccyx, surgery with full or partially removal of the coccyx bone is suggested. All patients are treated with steroid injections prior to surgery, with only short term relief. RESULTS A total of 138 consecutive patients was treated at the Sector for Spine Surgery, Middelfart Hospital and evaluated 3 and 12 months after surgery. Three months after surgery, 40% of the patients are pain free in sitting position, 47% of the patients are experiencing some degree of discomfort in sitting position but are improved and 13% of the patients are still experiencing pain while sitting. A total of 99 patients are satisfied, 1 year after the surgery. A total of 22 patients have hoped to have a bigger improvement and 17 patients are not satisfied. A total of 32 patients developed infections after surgery and received antibiotics, 5 reoperations was performed, 3 due to infections and 2 due to rupture of the skin after return to normal daily living 3 months after surgery. CONCLUSIONS Pain in the coccyx after trauma or birth, are a quite common condition in women. Patients with severe symptoms and a history of pain duration of more than 12-18 months, should be referred for spine surgical evaluation. Partial or complete resection of the coccyx, is a safe procedure with in most patients will relieve the pain and restore the ability to sit.

BACKGROUND CONTEXT Diagnostic workup for lumbar degenerative diseases (LDD) includes imaging such as radiographs, MRIs and/or CT-myelograms. If a patient fails conservative treatment, the surgeon must then decide if obtaining updated images prior to surgery is warranted. PURPOSE The purpose of this study is to determine if the timing of imaging impacts surgical decision-making as reflected by a difference in the rate of revision surgery in patients with lumbar degenerative disease. STUDY DESIGN/SETTING Analysis of private payor administrative claims database. PATIENT SAMPLE From the Health Care Service Corporation administrative claims database, adult patients (mean age 55) with LDD who had surgery including posterior lumbar decompression with and without fusion (1–2 levels) and at least five years of continuous coverage after the index surgery. OUTCOME MEASURES Revision surgery. METHODS From the Health Care Service Corporation administrative claims database, adult patients (mean age 55) with LDD who had surgery including posterior lumbar decompression with and without fusion (1–2 levels) and at least five years of continuous coverage after the index surgery were identified. Chi-square was used to determine differences in revision rates stratified by timing of each imaging procedure relative to the index procedure (≤6 months, 6–12 months, >12–24 months or >24 months). RESULTS Of 28,676 cases identified, 5,128 (18%) had revision surgery within 5years. The timing of preoperative MRI or plain radiographs was not associated with revision surgery. Among the entire cohort, there was a lower incidence of revision surgery in patients who had a CT-myelogram within 1 year prior to the index surgery (p=.017). This observation was strongest in patients undergoing decompression only (p=.002), but not significant in patients undergoing fusion (p=.845). CONCLUSIONS Routine re-imaging prior to surgery, simply because the existing MRI is 6-12 months old is probably unnecessary, at least as reflected in subsequent revision rates. The study also suggests that there may be a subset of patients for whom preoperative CT myelography reduces revision rates. This topic has important financial implications and deserves further study in a more granular dataset.

STUDY DESIGN Case report. OBJECTIVE To report on a case of traumatic pneumorachis in a child and to review the existing literature. SUMMARY OF BACKGROUND DATA Pneumorachis, the presence of air in the spinal canal, is an extremely rare finding. It may be caused by diverse pathologies such as incidental durotomy, barotrauma, pneumothorax, and trauma. In the polytrauma patient, it may be an indication of an occult spinal fracture. METHODS The case of a 15-year old with complete paraplegia presenting with pneumorachis is presented. RESULTS The initial computed tomography scan showed air in the spinal canal as well as surrounding subpleural and intramuscular spaces. However, there was near normal vertebral alignment with no fractures seen. Magnetic resonance imaging taken after the patient was stabilized showed a complete transaction of the spine at T3-T4 with ligamentous injury. A posterior instrumentation and fusion was performed. CONCLUSION In the pediatric patient presenting with neurologic deficits and pneumorachis, ligamentous injury of the spine, even in the absence of bony injury, should be suspected.

Background Context The Neck Disability Index (NDI), the short form-36 (SF-36) physical component summary (PCS), and pain scales for arm and neck pain are increasingly used to evaluate treatment effectiveness after cervical spine surgery. The minimum clinically important difference (MCID) is a threshold of improvement that is clinically relevant to the patient. However, the true goal is to provide the patient with a substantial clinical benefit (SCB). Purpose This study determines the MCID and SCB using common anchor-based methods for NDI, PCS, and pain scales for arm and neck pain in patients undergoing cervical spine fusion for degenerative disorders. Study Design/Setting The study setting is a longitudinal cohort in a multisurgeon spine specialty clinic. Patient sample The sample comprises 505 patients who underwent a cervical fusion for degenerative spine conditions and who have prospectively collected outcome scores with a minimum 1-year follow-up. Outcome Measures The outcome measures of the study were NDI, SF-36, and numeric rating scales for arm and neck pain. Methods The MCID and SCB values for NDI, PCS, and pain scales for arm and neck pain were determined using receiver operating characteristic (ROC) curve analysis with the Health Transition Item of the SF-36 as an anchor. The Health Transition Item asks a patient “Compared to one year ago, how would you rate your health in general now?” with answers ranging from “Much Better,” “Somewhat Better,” “About the Same,” “Somewhat Worse,” to “Much Worse.” An ROC curve was constructed for each measure. The ROC curve–derived MCID was the change score with equal sensitivity and specificity to distinguish the “Somewhat Better” from the “About the Same” patients. The ROC curve–derived SCB was the change score with equal sensitivity and specificity to distinguish the “Much Better” from the “Somewhat Better” patients. Distribution-based methods including the standard error of the mean and the minimum detectable change were also used to calculate MCID. Results The calculated MCID is 7.5 for the NDI, 4.1 for SF-36 PCS, and 2.5 for arm and neck pain. The calculated SCB is 9.5 for the NDI, 6.5 for SF-36 PCS, and 3.5 for arm and neck pain. Conclusions Patients with an eight-point decrease in NDI, a 4.1-point increase in PCS, and a three-point decrease in arm or neck pain can detect a minimally clinically important change. Patients with a 10-point decrease in NDI, a 6.5-point increase in PCS, and a four-point decrease in arm or neck pain can detect an SCB after cervical spine fusion.

Background Context Outcomes of spinal treatments are evaluated by clinical relevance: the proportion of patients who reach a minimum clinically important outcome change. Outcomes are evaluated through multiple measurements, and the inconsistency of outcome change across measurements is not known. Purpose The primary purpose of this study was to illustrate outcome inconsistencies after spinal surgery. Secondary goals of this study were to develop an index of overall change that incorporates outcome inconsistencies, to relate the index of overall change to patients' global assessment and satisfaction with treatment, to relate the index of global change to an intuitively understandable outcome: the level of tolerable pain. Study Design This study is a review of prospectively collected patient-reported outcomes data. Patient Sample Four hundred sixty patients from a large multicenter database were chosen. Those patients were included in the sample because they had undergone lumbar surgery and had baseline and 1-year follow-up scores. Baseline and 1-year follow-up scores for Oswestry Disability Index (ODI), physical component summary (PCS) of the Medical Outcome Study Short Form-36 (SF-36), numerical back and leg pain scales, and 1-year scores for satisfaction with results were included in the study. Outcome Measures The outcome measures of the study were preoperative and 1-year postoperative scores for ODI, PCS, back pain scale, leg pain scale, health transition item of the SF-36, and satisfaction with results scales. Methods Oswestry Disability Index, SF-36, and pain scales were administered before and 1 year after spinal surgery. Satisfaction with results questionnaires were administered 1 year after surgery. The following threshold values were previously established and were used to evaluate outcome changes: minimum clinically important difference (MCID), substantial clinical benefit (SCB), and standard error of the mean. The following proportions of patients were determined according to outcome changes: “deteriorated,” “no change,” “below MCID,” “above MCID,” and “above SCB.” The consistency of outcome change was determined amongst the four outcome measures. An index of overall change was developed and related to patients' answers to the health transition item of the SF-36 and to the satisfaction with results scale. The overall change index was also compared with the tolerable pain level. Results Only 40.5% of patients report consistent outcome changes on all four measures. The overall change index was significantly correlated to the global change and satisfaction scale (ρ=.67, p less than .001). The overall change index was clearly associated with the tolerable pain level. Conclusions Efforts should be made to take into account the inconsistency of outcomes and to make clinical relevance more readily understandable by patients and clinicians.

Background context Reported fusion rates for spine fusions using iliac crest bone graft (ICBG) vary between 40% and 100% because of different fusion techniques, patient comorbidity, diagnosis and assessment criteria. Purpose We report two-year results of single-level instrumented posterolateral fusions evaluated with radiographs, fine-cut computed tomography (CT) scans with reconstructions and outcome measures. Study design/ setting Retrospective analysis of data from a prospective multicenter randomized clinical controlled trial. Patient sample Patients with various degenerative diagnoses enrolled in the control arm of a Food and Drug Administration (FDA)-regulated, multicenter trial of single-level decompression and posterolateral fusion for degenerative lumbar disease. Outcome measures Short Form-36 (SF-36), Oswestry Disability Index (ODI), Numeric Rating Scales (0–20) for back, leg, and graft site pain, CT scans, anteroposterior and lateral flexion/extension radiographs. Methods Patients enrolled in an FDA-regulated, multicenter trial at 29 sites with degenerative lumbar disease treated with single-level instrumented posterolateral fusion with ICBG were included in the analysis. Demographic and surgical data were collected. Clinical outcomes were followed using standard metrics. Fusion was assessed by independent radiologists at 6, 12, and 24 months postoperatively. Two fusion criteria were compared: anteroposterior and flexion/extension radiographs to assess motion and bridging bone, with CT scans as needed to confirm bridging bone; and CT scan assessment for bridging bone only. Results One hundred ninety-four of 224 subjects (86.6%) completed the study. The mean operative time was 2.9 hours with a blood loss of 448.6 mL. The average graft volume was 36.3 mL. There were 21 (9.4%) wound infections, 18 (8.0%) incidental durotomies, 3 (1.3%) implant displacements, 2 (0.9%) malpositioned implants, and 17 (7.6%) graft-related complications. Twenty-seven patients (13.9%) required reoperation, the majority for nonunions. Fusion rates based on radiographs with selective CTs at 6, 12, and 24 months were 65.3%, 82.5%, and 89.3%, respectively. Fusion rates based on bridging bone on CT scans were 56.1%, 71.5%, 83.9%, respectively. Two-year improvement for all outcome measures was significant (p Conclusion In a large series of patients who had primary single-level instrumented posterolateral fusion with ICBG, evidence of bridging bone on fine-cut CT scans improved with time to 83.9% at 24 months. Significant improvement from baseline was noted in all clinical outcome measures at all time intervals with 75% achieving minimum clinically important difference (MCID) for ODI and 66% achieving MCID for SF-36 PCS.

Study Design. Cross-sectional cohort. Objective. The purpose of this study is to provide a model to allow estimation of utility from the Short Form (SF)-6D using data from the Oswestry Disability Index (ODI), Back Pain Numeric Rating Scale (BPNRS), and the Leg Pain Numeric Rating Scale (LPNRS). Summary of Background Data. Cost-utility analysis provides important information about the relative value of interventions and requires a measure of utility not often available from clinical trial data. The ODI and numeric rating scales for back (BPNRS) and leg pain (LPNRS), are widely used disease-specific measures for health-related quality of life in patients with lumbar degenerative disorders. The purpose of this study is to provide a model to allow estimation of utility from the SF-6D using data from the ODI, BPNRS, and the LPNRS. Methods. SF-36, ODI, BPNRS, and LPNRS were prospectively collected before surgery, at 12 and 24 months after surgery in 2640 patients undergoing lumbar fusion for degenerative disorders. Spearman correlation coefficients for paired observations from multiple time points between ODI, BPNRS, and LPNRS, and SF-6D utility scores were determined. Regression modeling was done to compute the SF-6D score from the ODI, BPNRS, and LPNRS. Using a separate, independent dataset of 2174 patients in which actual SF-6D and ODI scores were available, the SF-6D was estimated for each subject and compared to their actual SF-6D. Results. In the development sample, the mean age was 52.5 ± 15 years and 34% were male. in the validation sample, the mean age was 52.9 ± 14.2 years and 44% were male. Correlations between the SF-6D and the ODI, BPNRS, and LPNRS were statistically significant (P < 0.0001) with correlation coefficients of 0.82, 0.78, and 0.72, respectively. The regression equation using ODI, BPNRS, and LPNRS to predict SF-6D had an R 2 of 0.69 and a root mean square error of 0.076. The model using ODI alone had an R 2 of 0.67 and a root mean square error of 0.078. The correlation coefficient between the observed and estimated SF-6D score was 0.80. In the validation analysis, there was no statistically significant difference (P = 0.11) between actual mean SF-6D (0.55 ± 0.12) and the estimated mean SF-6D score (0.55 ± 0.10) using the ODI regression model. Conclusion. This regression-based algorithm may be used to predict SF-6D scores in studies of lumbar degenerative disease that have collected ODI but not utility scores.

Background: Previous studies have demonstrated the ability of recombinant human bone morphogenetic protein to achieve a solid fusion in anterior lumbar interbody arthrodesis. The purpose of this study was to compare iliac crest bone graft and recombinant human bone morphogenetic protein-2, combined with a carrier consisting of bovine collagen and β-tricalcium phosphate-hydroxyapatite to create a compression-resistant matrix, for instrumented single-level posterolateral arthrodesis. Methods: Four hundred and sixty-three patients with symptomatic single-level lumbosacral degenerative disease with no greater than grade-1 spondylolisthesis were treated with single-level instrumented posterolateral arthrodesis through an open midline approach. Patients were randomly assigned to either the recombinant human bone morphogenetic protein-2 matrix group (239 patients) or the autogenous iliac crest bone-graft group (224 patients). The Oswestry Disability Index, Short Form-36, and back and leg pain scores were determined preoperatively and at 1.5, three, six, twelve, and twenty-four months postoperatively. Radiographs and computed tomography scans were made at six, twelve, and twenty-four months postoperatively to evaluate for fusion. Results: The mean operative time and mean blood loss in the recombinant human bone morphogenetic protein-2 matrix group (2.5 hours and 343.1 mL, respectively) were significantly less than those in the iliac crest bone-graft group (2.9 hours and 448.6 mL). Both groups showed similar improvements in clinical outcomes and reduced pain. At twenty-four months, 60% of the iliac crest bone-graft group reported donor-site pain. At twenty-four months, fusion was evident in 96% of the patients in the recombinant human bone morphogenetic protein-2 matrix group compared with 89% in the iliac crest bone-graft group (p = 0.014). There was a significant difference (p = 0.011) in the rate of failures because of nonunion (eighteen patients with an iliac crest bone graft compared with six patients with the recombinant human bone morphogenetic protein-2 matrix). Also, the number of patients requiring second surgeries was significantly higher in the iliac crest bone-graft group (thirty-six patients) compared with the recombinant human bone morphogenetic protein-2 matrix group (twenty patients) (p = 0.015). Conclusions: The use of recombinant human bone morphogenetic protein-2 in instrumented posterolateral lumbar arthrodesis decreases operative time and blood loss and produces earlier and higher fusion rates than does iliac crest bone graft. Clinical outcomes are similar to those with iliac crest bone graft. Thus, the need for harvesting iliac crest bone is eliminated along with the morbidities associated with the harvest procedure. Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.

Study design Randomized clinical trial. Objective To perform a cost-utility analysis using actual cost data from a randomized clinical trial of patients over 60 years old who underwent posterolateral fusion using either rhBMP-2/ACS or iliac crest bone graft (ICBG). Summary background data Bone morphogenetic protein has been shown to be an effective bone graft substitute for spine fusion. However, a clinical trial-based economic analysis of rhBMP-2/ACS compared with iliac crest bone graft has not been done. Methods Patients over 60 years old requiring decompression and posterolateral fusion were randomized to rhBMP-2/ACS (n = 50) or ICBG (n = 52). A dedicated hospital coder and research nurse tracked each patient to determine direct costs of inpatient care and all postoperative healthcare encounters up to 2 years after surgery. Preoperative and 2-year-postoperative SF-6D utility scores for each patient were determined. A decision tree was created, which included the probability of complications, need for additional treatments and revision surgery; and the costs associated with initial surgery and treatment for complications and additional treatment for continued spine symptoms; and utility scores. Results The mean total 2-year cost for care (excluding complication and additional spine treatment costs) was $34,235 in the ICBG group and $36,530 in the rhBMP-2/ACS group. For the entire group, the mean cost to treat a major complication was $10,888, the cost of revision surgery for nonunion was $46,852, and additional treatment for spine-related events was $5892. In the ICBG group, 8 patients had complications; 20 had additional interventions, 5 of whom required revision for nonunion. In the rhBMP-2/ACS group, 6 patients had complications, 10 had additional interventions, and 1 required revision for nonunion. The cost of using rhBMP-2/ACS was $39,967 with a 0.11 mean improvement in SF-6D; and for ICBG the cost was $42,286 with a mean improvement of 0.10 in SF-6D. Conclusion There are more complications, increased need for additional treatment and revision surgery in patients over 60 years old receiving ICBG compared with rhBMP-2/ACS. This may account for higher costs and lower improvements in utility seen in patients receiving ICBG compared with rhBMP-2/ACS in this study population.

Background One of the primary difficulties in evaluating the effectiveness of lumbar fusion is that, with the exception of spondylolisthesis, specific diagnostic indications for surgery are poorly defined. Diagnostic specificity beyond the symptom of low back pain or the presence of lumbar degeneration needs to be delineated such that outcomes data can be effectively translated into clinical decision making or evidence-based guidelines. Purpose The purpose of this study was to report on prospectively collected clinical outcome measures, stratified by diagnosis, among a series of patients with lumbar degenerative disease whose treatment included lumbar spine fusion. Study design Demographics, diagnostic categorization, and clinical outcome measures were prospectively collected by six spine surgeons at a single tertiary spine center, as part of the surgeons' standard clinical practice. Patient sample Four hundred and twenty-eight patients were enrolled in the study and complete 1- and 2-year Health-Related Quality of Life (HRQOL) data were available in 327 patients whose treatment included decompression and posterolateral lumbar fusion. Outcome measures The Oswestry Disability Index (ODI), Short Form-36 (SF-36), numeric rating scales for back pain and leg pain. Methods Preoperative diagnosis was classified, in the primary surgical cases, as disc pathology, spondylolisthesis, instability, stenosis, or scoliosis. In revision cases, the diagnosis was classified as nonunion, adjacent level degeneration, or postdiscectomy revision. Patient-reported outcomes at 1 and 2 years post-op were assessed based on diagnostic stratification. Statistical evaluation of clinical outcome was performed for both mean net change in outcome scores and the percentage of patients reaching a minimum clinically important difference (MCID) threshold for each outcome measure. Results Preoperative diagnosis was spondylolisthesis (n=80), scoliosis (n=17), disc pathology (n=33), instability (n=21), stenosis (n=46), postdiscectomy revision (n=67), adjacent level degeneration (n=40), or nonunion (n=23). Evaluation of 2-year post-op HRQOL measures by diagnostic subgroup revealed the most substantial improvement in ODI score for patients with spondylolisthesis (22.7 points) and scoliosis (21.2 points). Patients with the diagnosis of disc pathology (16.2 points), postdiscectomy revision (14.0 points), instability (12.7 points), stenosis (10.6 points), and adjacent level degeneration (9.5 points) demonstrated a progressively smaller magnitude of ODI improvement. The least ODI improvement at 2 years after surgery was seen in patients with nonunion of a prior fusion (5.5 points). The percentage of patients reaching MCID for ODI at 2 years post-op ranged from 71.0% in the spondylolisthesis subgroup to 34.8% in the nonunion subgroup. The greatest SF-36 physical component score improvement at 2-year follow-up was seen in patients with disc pathology (7.9 points) and spondylolisthesis (7.7 points), followed by scoliosis (6.6 points) and stenosis (6.5 points), instability (5.6 points), postdiscectomy revision (5.3 points) nonunion (3.1 points) and adjacent level degeneration (2.5 points). No significant changes from Year 1 to Year 2 were noted in any of the subgroups. For SF-36 physical component score, percentage of patients reaching MCID ranged from 63.6% in the disc pathology subgroup to 25% in the nonunion subgroup. Conclusions This study supports the concept that added diagnostic specificity is a critical component in building an improved evidence base for lumbar fusion surgery. The magnitude of HRQOL improvement was not equal among diagnostic subgroups. The percentage of patients reaching an MCID level of improvement was also significantly influenced by diagnostic stratification. Without diagnostic specificity for entities beyond spondylolisthesis, the absence of well-defined study populations will continue to limit our ability to move toward evidence-based decision making.

Background context Computed tomography (CT) scan has been shown to be more accurate than radiographs in evaluating anterior interbody fusion but may still over-read the extent of fusion. Purpose To assess the reliability and accuracy of fine-cut CT scans with reconstructions in evaluating anterior lumbar interbody fusion (ALIF) with metallic cages using surgical exploration as the reference standard. Study design Accuracy of a diagnostic test referenced to the gold standard. Patient sample A total of 49 patients and 69 surgical levels. Outcome measures Evaluation of fine-cut CT scans for evidence of fusion with subsequent surgical exploration as the reference standard. Methods Forty-nine patients who underwent ALIF with metallic cages over 69 levels, who had a fine-cut CT scan before revision were included. Five spine surgeons unaware of the findings on surgical exploration evaluated pre-revision CT scans, classified these as fused or not; and determined the presence of a “sentinel sign” and a “posterior sentinel sign.” Kappa coefficients for interobserver reliability, sensitivity, and specificity to detect fusion were determined. Results There were 26 males and 23 females with a mean age of 43 years. There were 27 smokers. Average time from index to revision surgery was 22 months. Interobserver kappa for classification as fused or not was 0.25 with 70% to 97% sensitivity and 28% to 85% specificity. The interobserver kappa for the sentinel sign was 0.34 with 13% to 33% sensitivity and 77% to 92% specificity. The interobserver kappa for the posterior sentinel sign was 0.23 with 33% to 87% sensitivity and 56% to 90% specificity. Conclusions Raters generally overstated fusion with low specificities across raters and low consensus specificity. Overall accuracy of the posterior sentinel sign (74%) was higher than the sentinel sign (61%). The low kappa value indicates fair reliability. In patients with metallic interbody devices, surgeons should be cautious about interpreting the findings on fine-cut CT scans whether using a general assessment of the fusion, the sentinel sign, or the posterior sentinel sign.

Background: Validated health-related quality-of-life measures have become important standards in the evaluation of the outcomes of lumbar spine surgery. However, there are few well-defined criteria for clinical success based on these measures. The minimum clinically important difference is an important demarcation, but it could be considered a floor value rather than a goal in defining clinical success. Therefore, we sought to define thresholds of substantial clinical benefit for commonly used health-related quality-of-life measures following lumbar spine arthrodesis. Methods: Prospectively collected preoperative and one-year postoperative health-related quality-of-life measures from 357 patients who were managed with lumbar spine arthrodesis for the treatment of degenerative conditions were identified. Candidate substantial clinical benefit thresholds for the Short Form-36 physical component score, Oswestry Disability Index, and back and leg pain numeric rating scales were identified with use of receiver operating characteristic curve analysis. Receiver operating characteristic curves were used to discriminate between patients who reported being “much better” or “about the same” with use of the validated Short Form-36 health transition item and between those who reported being “mostly satisfied” or “unsure” with use of a nonvalidated but more surgery-specific satisfaction-with-results survey. For each health-related quality-of-life measure, three response parameters were used: net change, percent change, and raw score at the time of the one-year follow-up. Results: Substantial clinical benefit thresholds for the Short Form-36 physical component score were a 6.2-point net improvement, a 19.4% improvement, or a final raw score of ≥35.1 points. Substantial clinical benefit thresholds for the Oswestry Disability Index were an 18.8-point net improvement, a 36.8% improvement, or a final raw score of

Sagittal imbalance is a significant factor in determining clinical treatment outcomes in patients with deformity. Measurement of sagittal alignment using the traditional Cobb technique is frequently hampered by difficulty in visualizing landmarks. This report compares traditional manual measurement techniques to a computer-assisted sagittal plane measurement program which uses a radius arc methodology. The intra and inter-observer reliability of the computer program has been shown to be 0.92–0.99. Twenty-nine lateral 90 cm radiographs were measured by a computer program for an array of sagittal plane measurements. Ten experienced orthopedic spine surgeons manually measured the same parameters twice, at least 48 h apart, using a digital caliper and a standardized radiographic manual. Intraclass correlations were used to determine intra- and interobserver reliability between different manual measures and between manual measures and computer assisted-measures. The inter-observer reliability between manual measures was poor, ranging from −0.02 to 0.64 for the different sagittal measures. The intra-observer reliability in manual measures was better ranging from 0.40 to 0.93. Comparing manual to computer-assisted measures, the ICC ranged from 0.07 to 0.75. Surgeons agreed more often with each other than with the machine when measuring the lumbar curve, the thoracic curve, and the spino-sacral angle. The reliability of the computer program is significantly higher for all measures except for lumbar lordosis. A computer-assisted program produces a reliable measurement of the sagittal profile of the spine by eliminating the need for distinctly visible endplates. The use of a radial arc methodology allows for infinite data points to be used along the spine to determine sagittal measurements. The integration of this technique with digital radiography’s ability to adjust image contrast and brightness will enable the superior identification of key anatomical parameters normally not available for measurement on traditional radiographs, improving the consistency of sagittal measurement.

STUDY DESIGN Retrospective cohort analysis. OBJECTIVE To investigate and compare back and leg pain, and health-related quality of life measures in obese patients undergoing lumbar spine fusion, and to compare the results to nonobese patients. SUMMARY OF BACKGROUND DATA Obesity is a growing healthcare crisis in the United States and an increasing number of patients undergoing spinal surgery are obese. Obesity is also associated with low back pain. Some obese patients with significant structural spine problems may be dismissed as having their pain only coming from their weight. We compared patient outcomes in obese and nonobese patients undergoing lumbar fusion surgery. METHODS We retrospectively reviewed a single-center patient database of patients undergoing lumbar fusion and identified 270 patients with greater than 2-year outcome data. Body mass index (BMI) was calculated and patients were classified as obese (BMI >or= 30) or nonobese (BMI < 30). All patients completed Oswestry Disability Index (ODI), Short Form (SF)-36 questionnaires, and back and leg pain numerical rating scores before surgery and at 2 years. We compared clinical outcomes and complication rates in the 2 groups. RESULTS The overall study group consisted of 109 obese patients and 161 nonobese patients. Both the obese and nonobese patients demonstrated significant improvements in back pain, leg pain, SF-36 physical composite summary (PCS), and ODI scores (P < 0.001) at 2-year follow-up compared with baseline. There was no significant difference in the mean improvements seen in obese patients compared with nonobese patients with respect to back pain, leg pain, or SF-36 PCS or ODI scores. Both SF-36 PCS (P = 0.037) and ODI score (P = 0.028) at 2-year follow-up were better in the nonobese patients compared with the obese patients. Overall complication rates were slightly higher in the obese group (P = 0.045), predominantly because of wound-related complications. CONCLUSION Obese patients undergoing lumbar fusion achieve similar benefits to nonobese patients. Wound-related complications are more common in obese patients. Obese patients with otherwise good indications for lumbar fusion should not be denied this procedure because of their weight.

Background context There is mounting evidence supporting the efficacy of bone morphogenetic protein (BMP) for both anterior interbody and posterolateral lumbar fusion. However, the relative cost of BMP remains an important concern for physicians, hospitals, and payers. Purpose The purpose of this study is to report on the perioperative costs for patients treated with rhBMP-2 as compared with an iliac crest bone graft (ICBG) supplemented with graft extenders. Study design/setting A prospective randomized controlled trial of rhBMP-2/ACS (Infuse Bone Graft; Medtronic Sofamor Danek, Memphis, TN) versus ICBG±graft extender for lumbar spine fusion in patients over 60 years old. Patient sample One hundred two patients over 60 years old who required a posterolateral lumbar spine fusion randomized between receiving rhBMP-2/ACS or ICBG. Outcome measures All health-care costs over the first 3 months after surgery. Methods As part of a prospective randomized trial of rhBMP-2/ACS versus ICBG±graft extender for lumbar spine fusion, all costs over the first 3 months after surgery were directly recorded by a dedicated coder funded by Norton Healthcare, Louisville, KY. A dedicated research nurse also followed all patients throughout their hospital stay and posthospitalization recovery to identify any adverse events or additional outpatient medical care. Results Fifty patients received rhBMP-2/ACS and 52 underwent ICBG harvest. The mean hospital cost for the index admission was $24,736 for the rhBMP-2/ACS group and $21,138 for the ICBG group. Mean inpatient physician costs were $5,082 in the rhBMP-2/ACS group and $5,316 in the ICBG group. Costs associated with posthospital rehabilitation averaged $4,906 in the rhBMP-2/ACS group versus $6,820 in the ICBG group. Total payer expenditure for the 3-month perioperative period averaged $33,860 in the rhBMP-2/ACS group and $37,227 in the ICBG group. Conclusions The hospital carries the cost burden associated with the utilization of rhBMP-2/ACS. In contrast, the payer in a Diagnosis-Related Group (DRG) model achieves a net savings, based primarily on the decreased payment for inpatient rehabilitation, but also on decreased hospital reimbursement, physician costs, and other outpatient services.

Although outcomes after cervical fusion in rheumatoid arthritis (RA) patients are widely published, outcomes of lumbar fusion in RA patients has not been reported. Nineteen patients with RA, identified using ICD-9 and CPT codes, who underwent instrumented posterolateral lumbar fusion were matched for age, gender, smoking status, date, and level of surgery to a contemporaneous non-RA group. Medical records and radiographs were reviewed by the primary author who had no role in the treatment of these patients. The average age was 64 years in the RA group and 65 years in the non-RA group. The male to female ratio was 2:17 and 1:18, respectively. There were three smokers and two diabetics in each group. An average of 1.5 levels was fused in each group. Average follow-up was 24 and 27 months, respectively. In the RA group, 15 patients were taking DMARDs with 7 of those also taking oral steroids; 4 patients were taking NSAIDs only. There were seven complications (37%) in the RA group versus four (21%) in the non-RA group; wound infections in three patients (16%) in the RA group versus one (5%) in the non-RA group; and non-union in two patients (11%) in the RA group versus three (16%) in the non-RA group. Clinical outcomes were similar between the two groups with 74% of patients achieving good to excellent results in the RA group compared to 63% in the non-RA group (p = 0.692). Surgeons and their RA patients who undergo an instrumented lumbar fusion can expect a slightly higher complication rate than patients without RA which may be related to osteopenia and immunosuppression.

Study design Retrospective review of prospectively collected data, as part of an IRB-approved, FDA-regulated, randomized, nonblinded IDE trial of rhBMP-2 matrix for lumbar spinal fusion. Objectives The purpose of this study is to examine the influence of smoking on fusion rate and outcome in a large series of patients treated with an rhBMP-2 matrix (AMPLIFY) or iliac crest bone graft as part of a randomized IDE trial for single-level lumbar fusion. Summary of background data Preclinical studies suggest that bone morphogenetic proteins (BMPs) are able to reverse the negative influence of nicotine on fusion healing in animal models. It remains unclear if a similar benefit will be seen in humans, and if so, what formulation and amount of BMP will be required to achieve that improvement. Methods We reviewed the clinical and radiographic records of 148 patients who underwent single-level instrumented lumbar fusion at three spine centers as part of an ongoing FDA-regulated IDE trial. Clinical outcome measures included Oswestry Disability Index, SF-36, back, and leg pain scores. Radiographic measures were plain radiographs with flexion-extension views and fine cut computed tomography scans with sagittal and coronal reconstruction. Fusion success was determined by independent radiologist readings. Results At 2 years postoperatively, solid fusion was demonstrated in all 55 nonsmokers in the rhBMP-2 group (100%). Successful fusion was seen in 20 of 21 smokers in the rhBMP-2 group (95.2%). Fusion was achieved in 48 of 51 nonsmokers in the iliac crest bone graft (ICBG) group (94.1%), but only 16 of 21 smokers (76.2%) in the ICBG group. Conclusions The results of this study suggest that rhBMP-2 may enhance fusion rate in cigarette smokers undergoing single-level instrumented posterolateral lumbar fusion. Despite the improvement in fusion rate with rhBMP-2, clinical outcomes measures were still adversely affected in smokers.

Background Persistent low back pain in the young remains a significant diagnostic and treatment challenge for clinicians. Traditionally, chronic low back pain in this population has been attributed to either serious undetected pathology or psychosocial etiologies. This assumption may be incorrect because patients in this population may have underlying juvenile degenerative disc disease (JDDD), an important pathological diagnosis in the adult population. Purpose The purpose of this study is to report the presentation, radiographic findings, diagnosis, and treatment modalities of juvenile patients presenting with persistent low back pain for greater then 6 months. Study design This is a retrospective review of patients less than 21 years old referred to a spine specialty practice with persistent low back pain. Patient sample The charts of 1,877 patients less than 21 years old referred to a spine specialty practice for the evaluation of spinal problems. Outcome measures Magnetic resonance images (MRI) were obtained and reviewed by a neuroradiologist and two orthopedic surgeons. Methods Patients younger than 21 years old with persistent low back pain for greater that 6 months were identified. Patients with scoliosis, Scheuermann's kyphosis, spondylolisthesis, fracture, tumor, and metabolic bone disease were excluded. Standard demographic information, relevant medical history and physical examination findings were collected. Patients were evaluated with an MRI of their spines to detect any potential underlying pathology. The success of various treatment modalities used was reviewed. The findings of this study were correlated to those of the available literature following a thorough review. Results Seventy-six patients (34 males, 42 females) with degenerative disc disease were identified on MRI. The mean age was 17.1 years (range 11.5–21.0) with a mean body mass index (BMI) of 24.5 (range 17.7–35.4). Thirty-one had associated radiculopathy. There was 11 smokers, 20 involved in athletics, 17 with co-morbidities, and 9 with a BMI greater than 30. A distinct subgroup of 13 patients with multilevel concurrent spinal stenosis was documented. Four of this subgroup required surgical intervention for severe radicular or claudication symptoms. The majority of JDDD patients were successfully treated with nonoperative modalities. Conclusion The findings of this study question whether lumbosacral degenerative disc disease, commonly thought to exist only in an older population, in fact begins earlier in selected patients. Our study confirms the findings of others that there is a definite population of juveniles that present with chronic low back pain who have degenerative disc disease identified on MRI. Within this population is a subgroup of patients with concurrent congenital spinal stenosis. Most patients with JDDD appear to be well managed by traditional nonoperative treatment modalities.

Study design Accuracy of a diagnostic test referenced to the gold standard. Objectives This study evaluated the reliability and accuracy of fine-cut computed tomography scans with coronal and sagittal reconstructions to determine the status of an instrumented posterolateral fusion by using surgical exploration as the reference standard. Summary of background data There is still a need for a reliable and accurate noninvasive method to determine the status of a spinal fusion. Methods Three spine surgeons reviewed 93 prerevision fine-cut CT scans over 163 fused levels of consecutive patients who had revision surgery after an instrumented posterolateral lumbar fusion. The facet joints and posterolateral gutters at each level were classified as fused or not. The surgeons were unaware of the findings on surgical exploration. Interobserver variability and likelihood ratios for a solid fusion when both, one, or none of the facets and when both, one, or none of the posterolateral gutters were fused, were calculated. Results There were 42 males and 51 females with a mean age of 57 years (range, 19-86 years) at revision. On exploration, there were 32 (19.6%) nonunions over 163 levels. The kappa for interobserver variability for evaluating facet fusions (0.42) was moderate and for posterolateral fusions (0.62) was substantial. The probability of a solid fusion on exploration was higher when both posterolateral gutters were fused on CT scan (89%) than when both facets were fused on CT scan (74%). When both facets and both posterolateral gutters were fused on CT scan, the probability of a solid fusion on exploration is 96%. The absence of fusion of one or both facets or one posterolateral gutter were poor predictors of nonunion on surgical exploration. Conclusions The CT scan reading of either one or both posterolateral gutters fused or both facets fused were moderately predictive of a solid fusion on surgical exploration. Fine-cut CT scans with reconstructions are moderately predictive of the presence of nonunion when both facets are not fused.

STUDY DESIGN A longitudinal cohort. OBJECTIVE The aim of this study was to determine the extent of health care resource utilization decrease 2 years after lumbar spinal fusion. SUMMARY OF BACKGROUND DATA Despite the assumption that surgery will minimize the need for ongoing nonsurgical treatment, the impact of lumbar fusion on subsequent health care resource utilization has not been effectively studied. METHODS Patients who had continuous coverage by a major insurer during the year before decompression and posterolateral instrumented spinal fusion, and the 2 and a half years following were identified. All charges processed during this time-period were collected. Charges associated with the index surgery, the 90-day postoperative period, and those unrelated to spinal care were excluded. Associations with Oswestry Disability Index (ODI) score improvement at 2 years after surgery and health care resource utilization were determined. RESULTS Sixty-six patients were included in the analysis. The mean age was 59 years and 39% were males. There was a decrease in health care utilization costs 1 year after surgery ($3267.59) compared with pre-op ($4246.32), but this was not statistically significant (P = 0.197). There was a statistically significant decrease in costs during the second year after surgery ($1420.97) compared with either pre-op (P = 0.000) or 1-year costs (P = 0.001). No statistically significant correlations could be found between change in ODI scores and costs incurred at either year post-op. CONCLUSION Health care utilization decreased at 1 year and significantly at 2 years after lumbar fusion. However, there was no correlation between use of nonsurgical resources and clinical outcome based on ODI scores. This raises the question as to whether these resources were used in a rational manner. This cooperative study between a major insurer and a tertiary spine center provides improved insight into the cost profile of lumbar fusion surgery. Further study is needed to determine whether ongoing post-op treatment is necessary or simply established practice. LEVEL OF EVIDENCE 2.

Background The durability of adult spinal deformity surgery remains problematic. Revision rates above 20 % have been reported, with a range of causes including wound infection, nonunion and adjacent level pathology. While some of these complications have been amenable to changes in patient selection or surgical technique, Proximal Junctional Kyphosis (PJK) remains an unresolved challenge. This study examines the contributions of non-mechanical factors to the incidence of postoperative sagittal imbalance and PJK after adult deformity surgery. Methods We reviewed a consecutive series of adult spinal deformity patients who required revision for PJK from 2013 to 2015 and examined in their medical records in detail. Results Neurologic disorders were identified in 22 (76 %) of the 29 PJK cases reviewed in this series. Neurologic disorders included Parkinson’s disease (1), prior stroke (5), metabolic encephalopathy (2), seizure disorder (1), cervical myelopathy (7), thoracic myelopathy (1), diabetic neuropathy (5) and other neuropathy (4). Other potential comorbidities affecting standing balance included untreated cataracts (9), glaucoma (1) and polymyositis (1). Eight patients were documented to have frequent falls, with twelve cases having a fall right before symptoms related to the PJK were noted. Conclusion PJK is an important contributing factor to the substantial and unsustainable rate of revision surgery following adult deformity correction. Multiple efforts to avoid PJK via alterations in surgical technique have been largely unsuccessful. This study suggests that non-mechanical neuromuscular co-morbidities play an important role in post-operative sagittal imbalance and PJK. Recognizing the multi-factorial etiology of PJK may lead to more successful strategies to avoid PJK and improve surgical outcomes.

Background Context Over the past decade, the number of adult spinal deformity (ASD) surgeries has more than doubled in the United States. The complex surgeries needed to manage ASD are associated with significant resource utilization and high cost, making them a primary target for increased scrutiny. Accordingly, it is important to not only demonstrate value in ASD surgery as clinical effectiveness but also to translate outcome assessment to cost-effectiveness. Purpose To compare the difference between Medicare allowable rates and the actual, direct hospital costs for ASD surgeries. Study Design Longitudinal cohort. Patient Sample Consecutive patients enrolled in an ASD database from a single institution. Outcome Measures Short Form (SF)-6D. Methods Consecutive patients enrolled in an ASD database from a single institution from 2008 to 2013 were identified. Direct hospital costs were collected from hospital administrative records for the entire inpatient episode of surgical care. Medicare allowable rates were calculated for the same inpatient stays using the year-appropriate Center for Medicare-Medicaid Services Inpatient Pricer Payment System Tool. The SF-6D, a utility index derived from the SF-36v1, was used to determine quality-adjusted life years (QALY). Costs and QALYs were discounted at 3.5% annually. Results Of 580 surgical ASD patients eligible for 2-year follow up, 346 (60%) had complete baseline and 2-year data, and 60 were Medicare beneficiaries comprising the cohort for the present study. Mean SF-6D gained is 0.10 during year 1 after surgery and 0.02 at year 2, resulting in a cumulative SF-6D gain of 0.12 over 2 years. Mean Medicare allowable rate over the 2 years is $82,050 (range $42,383 to $220,749) and mean direct cost is $99,114 (range $28,447 to $217,717). Mean cost per QALY over 2 years is $683,750 using Medicare allowable rates and $825,950 using direct costs. This difference of $17,181 between the 2 cost calculation represents a 17% difference, which was statistically significant (p Conclusions There is a significant difference in direct hospital costs versus Medicare allowable rates in ASD surgery and in turn, there is a similar difference in the cost per QALY calculation. Utilizing Medicare allowable rates not only underestimates (17%) the cost of ASD surgery, but it also creates inaccurate and unrealistic expectations for researchers and policymakers.

Background Context Obesity is a growing problem in health care. Studies have demonstrated similar functional outcomes but higher complication rates after spine surgery in obese patients. Purpose This study aimed to compare patient-reported outcomes and revision rates 5 years after instrumented posterior lumbar fusion between normal, overweight, and obese patients. Study design Propensity matched case control. Patient sample Patients who had posterior instrumented lumbar spinal fusion from 2001 to 2008 from a single spine specialty center with complete preoperative and 5-year postoperative outcome measures were identified. Outcome measures Oswestry Disability Index (ODI), Back Pain (0–10) and Leg Pain (0–10) Numeric Rating Scales, and Short Form-36 Physical Composite Summary Scores (SF-36 PCS). Methods Three comparison groups, one with body mass index (BMI) ≥20–25 kg/m 2 (normal), another with ≥25– 2 (overweight), and another with ≥30–40 kg/m 2 (obese) were created using propensity matching techniques based on demographics, baseline clinical outcome measures, and surgical characteristics. Five-year postoperative outcome measures and revision rates in the three groups were compared. One-way analysis of variance was used to compare continuous variables, and Fisher exact test was used to compare categorical variables between the groups. Significance was set at p Results There were 82 cases matched in each cohort. Estimated blood loss (440 cc vs. 702 cc vs. 798 cc, p=.000) and operative time (234 minutes vs. 263 minutes vs. 275 minutes, p=.003) were significantly greater in the overweight and obese patients. Improvements in ODI (14.2 vs. 9.6 vs. 10.4, p=.226), SF-36 PCS (5.9 vs. 2.9 vs. 3.5, p=.361), back pain (3.0 vs. 2.0 vs. 2.1, p=.028), and leg pain (3.0 vs. 2.3 vs. 2.3, p=.311) scores were similar among the groups. Revision rates (14 vs. 15 vs. 13, p=.917), and time between index and revision surgery (p=.990) were similar among the three groups as well. Conclusion When considering a subset of patient-reported outcomes and revision surgery after 5 years, patients with an elevated BMI >25 at baseline did not appear to have worse outcomes than those with a normal BMI of 20–25 when undergoing posterior lumbar fusion surgery. Obesity should not be considered a contraindication to surgery in patients with appropriate surgical indications.

Diagnosis is crucial in early-stage lumbar spondylolysis, as osseous healing can occur with conservative treatment. Single-photon emission computed tomography (SPECT) traditionally has been the most sensitive modality for diagnosing active (early) spondylolysis. More recently, high signal change (HSC) in the pedicle or pars interarticularis on fluid-specific (T2) magnetic resonance imaging (MRI) has been shown to be important in the diagnosis of early spondylolysis. We conducted a study to determine the clinical and radiographic characteristics associated with the diagnosis of early or active spondylolysis. Fifty-seven patients with a total of 108 pars defects and a mean age of 14.6 years were retrospectively identified. Defects with a positive SPECT or HSC on T2 MRI were classified as active. There were 49 active and 59 inactive defects. The active and inactive groups did not differ in age, body mass index, symptom duration, lumbar lordosis, pelvic incidence, slip percentage, or laterality. There was a difference in sex (35 vs 19 males; P.0001) and presence of listhesis (16 vs 35; P = .006). Active or early juvenile spondylolysis appears to be associated with male patients and the absence of listhesis, which may be important in identifying patients with a higher potential to experience osseous healing with nonoperative treatment.

STUDY DESIGN: Longitudinal cohort.OBJECTIVES: To evaluate the long-term radiologic outcomes in adolescent idiopathic scoliosis (AIS) patients more than 22 years after treatment.SUMMARY OF BACKGROUND DATA: Although treatment for AIS is prophylactic and is aimed at preventing curve progression, very few studies report long-term outcomes of treatment.METHODS: AIS patients treated with Boston brace or posterior spinal fusion (PSF) with Harrington-dorso-transverse traction (DTT) instrumentation from 1983 to 1990 were requested to return to clinic. Subsequently, 36-inch standing radiographs were obtained after patient consent. Cobb angles were compared with pretreatment and immediate posttreatment radiographs. Any evidence of adjacent-level disease or local kyphosis was also noted.RESULTS: One hundred fifty-nine (78%) of 219 patients were available for follow-up, 66 braced and 93 surgical. There were 85 females with an average age at surgery of 14.3 years and an average age at follow-up of 37.6 years. The mean length of follow-up was 24.5 years (range, 22-30 years). There was a statistically significant curve progression of 2.9° in the PSF group. There was a greater degree of curve progression in the braced group (5.5°), but this was not statistically significant. Proximal segment degeneration was seen in 8 (5%), 2 in the brace cohort and 6 in the PSF cohort. Distal segment degeneration was seen in 26 (16%) patients, 4 treated with brace and 22 treated with PSF. No patient developed proximal junction kyphosis. Three patients in the PSF cohort required additional surgery for distal adding-on. Four patients had a noncontiguous L5-S1 fusion, three from the PSF cohort and one from the braced cohort.CONCLUSION: In this cohort with an average follow-up of 24.5 years, with 78% available for follow-up, both the braced and surgically treated patients had a very small degree of curve progression, with a small incidence of distal segment degeneration and reoperation.LEVEL OF EVIDENCE: III.

Background The purpose of this study is to compare liposomal bupivacaine to a modified (Ranawat) local injection for total knee arthroplasty (TKA). Methods This is a prospective, randomized study of 105 consecutive patients undergoing primary TKA. Group A patients received a periarticular injection with liposomal bupivacaine and group B with a mixture of ropivacaine, epinephrine, ketorolac, and clonidine. There were 54 patients in the group A (liposomal bupivacaine) and 51 in group B. Results There were no differences in the groups with respect to age, sex, and preoperative knee scores. There were no differences with respect to postoperative narcotic usage and knee range of motion. Conclusion Liposomal bupivacaine as a periarticular injection after TKA demonstrated similar pain levels, narcotic usage, and range of motion compared to a modified Ranawat suspension but improved walking distance.

BACKGROUND: Since 1962 to the mid eighties the Harrington Rod instrumentation was the Golden standard for surgical treatment of Adolescent Idiopathic Scoliosis (AIS). The Boston braces were introduced in the 1970´s and are still used as a conservative treatment, for curves less than 40°. Very few long-term studies exists, focusing on the health related quality of life. The purpose of this study was to evaluate the long-term health related outcome, in a cohort of AIS patients, treated 25 years ago.METHOD: 219 consecutive patients treated with Boston brace (Brace) or posterior spinal fusion (PSF) using Harrington- DDT instrumentation between 1983 and 1990 at Rigshospitalet Copenhagen, were invited to participate in a long-term evaluation study. A validated Danish version of the Scoliosis Research Society 22R (SRS22R) and Short Form-36 (SF36v1) were administrated to the patients two weeks before the clinical and radiological examination.RESULTS: 159 (72,6 %) patients participated in the clinical follow up and questionnaires, 11 patients participated only in the questionnaires, 8 emigrated, 4 were excluded due to progressive neurological disease and 2 were deceased. The total follow up was 170 patients (83 %), and the average follow up was 24.5 years (22-30 years). SRS22R domain scores were within the range described as normal for the general population with no statistical difference between the groups except in the Satisfaction domain, where the PSF group had better scores than the braced group. The SF36 PCS and MCS scores in both AIS cohorts were similar to the scores for the general population.CONCLUSION: HRQOLs, as measured by the SRS22R and SF-36, of adult AIS patients treated with Boston brace or PSF during adolescence were similar to the general population. No clinical progression of the deformity has been detected during the 25-year follow up period. The PSF group had a small but statistically significant higher score in the Satisfaction domain compared to the braced group.TRIAL REGISTRATION: S-20110025 Regional Committees on Health Research Ethics for Southern Denmark.

Iatrogenic dural tears during lumbar spine surgery are not uncommon and may have multiple long-term sequelae if not managed promptly and definitively. Sequelae include pseudomeningocoeles due to a persistent cerebrospinal fluid leak, which may result in a subarachnoid hemorrhage or subdural hematoma. These, in turn, can lead to adult communicating hydrocephalus. The purpose of this study is to describe a case of an intraoperative iatrogenic dural tear leading to the formation of a pseudomeningocoele and progressing to hydrocephalus. We present a case of a 62-year-old female who had an iatrogenic dural tear during a lumbar decompression and instrumented fusion. Attempts at closure were unsuccessful, which led to the formation of a pseudomeningocoele and an ascending subdural hygroma, progressing into a communicating hydrocephalus which was treated with a ventriculoperitoneal shunt. Imaging studies and clinical follow up after the incidental durotomy demonstrate complications arising from the persistent cerebrospinal fluid leak, beginning with the formation of the pseudomeningocoele and progression to hydrocephalus. Based on these imaging studies, it was possible to illustrate the development of each of the complications. The need for prompt recognition and proper management of iatrogenic dural tears are emphasized in order to avoid future complications that may arise from inadequate or proper treatment.

Background Attitudes regarding non-operative treatment for adolescent idiopathic scoliosis (AIS) may be changing with the publication of BRAiST. Physiotherapeutic Scoliosis Specific Exercises (PSSE) are used to treat AIS, but high-quality evidence is limited. The purpose of this study is to assess the attitudes of members of the Scoliosis Research Society towards PSSE. Methods A survey was sent to all SRS members with questions on use of Physical Therapy (PT) and PSSE for AIS. Results The majority of the 263 respondents were from North America (175, 67 %), followed by Asia (37, 14 %) and Europe (36, 14 %). The majority of respondents (166, 63 %) prescribed neither PT nor PSSE, 28 (11 %) prescribed both PT and PSSE, 39 (15 %) prescribe PT only and 30 (11 %) prescribe PSSE only. PT was prescribed by 67 respondents, as an adjunct to bracing (39) and in small curves (32); with goals to improve aesthetics (27) and post-operative outcomes (25). Of the 196 who do not prescribe PT, the main reasons were lack of evidence (149) and the perception that PT had no value (112). PSSE was prescribed by 58 respondents. The most common indication was as an adjunct to bracing (49) or small curves (41); with goals to improve aesthetics (36), prevent curve progression (35) and improve quality of life (31). Of the respondents who do not prescribe PSSE, the main reasons were lack of supporting research (149), a perception that PSSE had no value (108), and lack of access (63). Most respondents state that evidence of efficacy may increase the role of PSSE, with 85 % (223 of 263) favoring funding PSSE studies by the SRS. Conclusion The results show that 22 % of the respondents use PSSE for AIS, skepticism remains regarding the benefit of PSSE for AIS. Support for SRS funded research suggests belief that there is potential benefit from PSSE and the best way to assess that potential is through evidence development.

STUDY DESIGN Longitudinal cohort. OBJECTIVE To evaluate the relationship between Scoliosis Research Society-22R (SRS22-R) domains and satisfaction with management in patients who underwent surgical correction for adult spine deformity. SUMMARY OF BACKGROUND DATA The SRS-22R is used to measure clinical outcomes in adult spine deformity patients. The relationship between patient satisfaction and SRS-22R domain scores, the Oswestry Disability Index (ODI) and radiographical parameters has not been reported at 5-year follow-up. METHODS 135 patients with adult spinal deformity at a single institution who underwent a posterior spinal fusion of 5 levels or more to the sacrum and had complete SRS-22R pre- and minimum 5-year postoperative were identified. Wilcoxon tests were used to compare preoperative and 5-year postoperative scores. Spearman correlations were used to evaluate associations between the 5-year SRS-22R Satisfaction score and changes in SRS-22R domain scores, SubScore (SRS-22R Total-Satisfaction), ODI, and radiographical parameters. RESULTS There were 125 females and 10 males with a mean BMI of 26.6 kg/m and mean age of 53.6 years. There were 74 primary and 61 revision surgeries with a mean 9.9 levels fused and mean follow-up of 67 months. There was a statistically significant improvement between paired pre- and 5-year postop SRS-22R domain scores and most radiographical parameters, commonly P ≤ 0.001. The majority of patients had an SRS-22R Satisfaction score of 3.0 or more (88%) or 4.0 or more (67%), consistent with a moderate ceiling effect. Correlations for SRS-22R domain scores were all statistically significant and either weak [Mental (0.26), Activity (0.27), Pain (0.35), or moderate (Appearance (0.59))]. SRS-22R SubScore (0.54) and ODI (0.43) also had a moderate correlation. Correlations for all radiographical and operative parameters were either very weak or weak. CONCLUSION SRS-22R Appearance, SubScore, and ODI correlate most with patient satisfaction in adult deformity patients undergoing 5 or more level fusion to the sacrum at 5-year follow-up. LEVEL OF EVIDENCE 2.

The goal of surgical treatment of adolescent idiopathic scoliosis (AIS) is to prevent disability associated with curve progression. Few investigators have considered whether the function of patients with AIS becomes adversely affected by major spine fusion surgery. Tertiary referral center patients (age, 10-17 years) who underwent spinal deformity correction a minimum of 5 years earlier were identified. Scoliosis Research Society-22R (SRS-22R) and Short Form-12 (SF-12) were administered. Data were available for 118 patients. Mean age was 14.1 years at surgery and 26.8 years at follow-up. Mean outcome scores were 50.9 (SF-12 physical composite summary), 49.4 (SF-12 mental composite summary), and 4.0 (SRS-22R total). One hundred patients (85%) were working. Common symptoms included occasional back pain (90, 76%), limited range of motion (52, 44%), activity limitations (54, 46%), waistline imbalance (41, 35%), rib prominence (28, 24%), wound/scar problems (18, 15%), and shortness of breath (18, 15%). Prominent implants were reported by 11 patients (9%). Seven of 14 reoperations were for instrumentation removal. There was a high incidence of occasional back pain and activity complaints after surgery for AIS in our cohort. However, normal SF-12 scores suggested that these symptoms did not lower the patients' general health.

Background context Patient-based quality of life scales have become a critical element of post-op assessment for lumbar fusion surgery. The most extensive outcomes data have been generated through FDA-regulated IDE trials for new technologies, which produce excellent data but are constrained by strict enrollment criteria and limited indications. This raises a question as to whether the excellent results seen in these IDE trials can be reproduced in standard clinical practice. Purpose The purpose of this study was to analyze surgical results based upon standardized outcome tools, across a spectrum of interventions, for one- and two-level lumbar spine fusion procedures. Design/setting This study is a retrospective review of prospectively collected patient based outcomes data. Patient sample Four hundred ninety-seven patients, who underwent 1- or 2-level lumbar spine fusion at five participating spine centers, utilizing a variety of surgical techniques. Enrollment criteria included available demographic, surgical and clinical outcome data. At a minimum, patients had pre-op and one year post-op SF-36 data. In many cases two-year post-op SF-36 data and concomitant Oswestry Disability Index (ODI) data was available. Outcome measures SF36 and ODI. Methods The patient population included 270 females and 227 males, with a mean age of 47 years. Sixty-five percent (N=324) had one level fusions and 35% (N=173) had two level fusions. Demographic data collected included age, gender, BMI, surgical history, smoking history and work status. Data was analyzed with repeated measures analysis of variance (ANOVA). Results SF-36 Physical Composite Score (PCS) improved a mean 9.9 points at one year post-op and 9.5 points at two years post-op. ODI improved a mean 22.2 points at one year post-op and 22.1 points at two years post-op. SF-36 PCS data for surgical approach subgroups revealed greater improvement (p=.03) in the ALIF group as compared to the PSF, PLIF/TLIF, or 360° fusion groups (12.6 points vs. 8.8, 9.3, 8.4 points) at 1 year post-op. At 2 years post-op, there was greater improvement (p=.02) in the ALIF and PSF groups as compared to the PLIF/TLIF and 360° fusion groups (13.8 and 11.2 points vs. 7.7 and 6.3 points). SF-36 PCS data demonstrated similar baseline scores for patients with and without prior decompression, but a significantly greater rate of improvement (11.3 vs. 7.2 points, p=.002) for patients without prior lumbar decompression surgery. The ODI data indicated a significantly greater disability at baseline in the prior decompression group, with greater improvement (21.7 vs. 17.5 points) in patients without prior surgery. Conclusions This study documents improved outcomes, based on SF-36 and ODI scores, in patients undergoing lumbar fusion for one and two level degenerative disc disease. The findings also demonstrate efficacy for all of the surgical techniques studied, suggesting that surgeons can appropriately select the surgical strategy with which they are most adept.

This is a prospective study of 26 patients undergoing posterior cervical spine instrumentation with lateral mass or pedicle screws to determine the correlation between intraoperative screw stimulation thresholds and the position of posterior cervical lateral mass and pedicle screws.One hundred forty-seven posterior cervical screws (122 lateral mass screws and 25 C7 pedicle screws) in 26 patients were electrically stimulated intraoperatively and stimulation thresholds recorded. Computed tomography (CT) scans were taken postoperatively and were evaluated independently to assess screw position. Electromyographic (EMG) thresholds and CT data were compared to assess the accuracy of the EMG screw stimulation technique in detecting screw malposition.Intraoperative electrical stimulation was accurate in verifying screw position. A stimulation threshold of 15 mA provided a 99% positive predictive value (89% sensitivity, 87% specificity) that the screw was within the lateral mass or pedicle. Stimulation values of 10-15 mA provided a 13% predictive value (66% sensitivity, 90% specificity) that the screw was within the lateral mass or pedicle. A stimulation value of10 mA provided a 100% predictive value that the screw was malpositioned (70% sensitivity, 100% specificity).Intraoperative evoked EMG monitoring is a valuable tool in posterior cervical instrumentation using lateral mass and pedicle screws. Stimulation thresholds in this study correlated with screw position. Stimulation values of15 mA reliably predict acceptable screw position. Values between 10 and 15 mA are generally associated with acceptable screw position, although exploration is recommended. Values below 10 mA are associated with screw malposition and warrant exploration, repositioning, and possible removal.

Posterior spinal arthrodesis is commonly employed in patients with spinal stenosis, although certain patients may require additional interbody support applied either anteriorly or posteriorly. Although autograft, allograft, and recent biologic agents such as rhBMP-2 are available for arthrodesis, meticulous fusion technique is still essential for a successful result. Posterior pedicular screw and rod fixation remain the most commonly employed internal fixation for the treatment of spinal stenosis since it allows for stabilization of instability, correction of deformity, and improved arthrodesis success. This article outlines the etiology, pathogenesis, current treatment options, and various surgical techniques available for the treatment of spinal stenosis.

Spondylolisthesis is defined as the forward translation of one vertebra on another in the sagittal plane. There are multiple etiologies of spondylolisthesis, including the degenerative and postsurgical varieties. Degenerative spondylolisthesis presents in a more elderly population and usually involves the lumbar fourth and fifth vertebrae. The pathogenesis is believed to be secondary to the progressive degeneration of the disc and facets, which results in instability and pathologic segmental motion. Clinically, patients present with low back pain and neurological symptoms consisting of spinal claudication or radiculopathy. A postsurgical spondylolisthesis is often the inevitable result of decompression with up to 50% of patients developing late instability that requires stabilization. Similar to a degenerative spondylolisthesis, these patients will present with reoccurrence of radicular pain associated with increasing low back pain. A spondylolisthesis is identified with plain radiographs, which should include flexion and extension to identify pathologic motion. An MRI is useful for the evaluation of stenosis, while a Myelo/CT with flexion and extension weight-bearing views is superior for the evaluation of dynamic instability. Nonoperative treatment consists of bracing, nonsteroidal antiinflammatory medication, epidural blocks, weight reduction, and physical therapy. Surgical indications include severe back pain or neurological symptoms. Following decompression, an arthrodesis is recommended for a degenerative spondylolisthesis since long-term studies have demonstrated improved outcomes. A postsurgical spondylolisthesis, by definition, is unstable and requires a concurrent stabilization. Surgical options include posterior pedicular rod and screw fixation, posteriorly placed interbody implants combined with pedicular instrumentation, or combined anterior and posterior procedures. Materials available for fusion include autograft, allograft, or new biologic graft substitutes such as rhBMP-2. This article reviews the etiology and pathogenesis of spondylolisthesis along with recommended treatment options and surgical techniques to enable clinicians to insure superior patient treatment outcomes.

Study Design. Prospective, randomized, unblinded study of iliac crest bone graft (ICBG) versus recombinant human bone morphogenetic protein-2/compression resistant matrix (rhBMP-2/CRM)in a posterolateral instrumented fusion procedure. Objectives. Document initial radiographic characteristics, based on computed tomography, with rhBMP-2/CRM for posterolateral fusion at 6 and 12-month intervals. of Background Data. As the acceptance of INFUSE bone graft as an ICBG replacement becomes more widespread, surgeons have begun to study applications for rhBMP-2 in posterior spinal fusion. Preclinical studies have examined variables including carrier composition, rhBMP-2 concentration, and rhBMP-2 dose. Pilot studies have been performed with encouraging initial results. Methods. Patients with single level lumbar degenerative disease were enrolled in a randomized study of ICBG versus rhBMP-2/CRM in a posterolateral instrumented fusion procedure. Computed tomography scans at 6 and 12 months were graded as demonstrating no fusion (grade 1), partial or limited unilateral fusion (grade 2), partial or limited bilateral fusion (grade 3), solid unilateral fusion (grade 4), or solid bilateral fusion (grade 5). Results. At our institution, 74 patients (38 rhBMP-2/ CRM, 36 ICBG) reached minimum 1-year follow-up and were included in this analysis. Mean fusion grade (scale 1-5) at 6 months after surgery was 4.35 in the rhBMP-2/ CRM group versus 3.09 in the ICBG group (P < 0.0001). At 1 year after surgery mean fusion grade was 4.62 in the rhBMP-2/CRM group versus 3.77 in the ICBG group (P < 0.0023). Conclusions. These early results are encouraging and suggest a more rapid incorporation and development of the fusion mass with rhBMP-2/CRM than iliac crest autograft in a single level posterior instrumented fusion.

Study design Case series. Objectives The results of surgical treatment of osteomyelitis with anterior debridement and fusion followed by delayed posterior stabilization and fusion are presented. Methods Forty-two patients with vertebral osteomyelitis are presented. There were 5 cervical, 12 thoracic, 1 thoracolumbar, 19 lumbar, and 5 lumbosacral lesions. The most frequently identified organism was Staphylococcus aureus. Most patients had significant comorbidities, including diabetes, or were immunocompromised. Ninety percent had elevated erythrocyte sedimentation rates and C-reactive proteins, while white blood cell counts were less reliably elevated. Imaging studies included radiographs, CT scans, and MRIs. All patients were treated with anterior debridement and strut grafting followed by 14.4 days of intravenous antibiotics and delayed instrumented posterior fusions and received 6 weeks of intravenous antibiotics after surgery. Results All patients had resolution of their infections with no recurrence. There were two deaths. Neurologic deficits resolved in all patients. The diagnosis of pyogenic vertebral osteomyelitis is frequently delayed and presents a significant surgical challenge. The indications for surgical debridement were neurologic compromise, failed medical treatment, soft tissue extension, extensive vertebral body and disc space destruction, and progressive deformity. Many of these patients were severely ill at presentation and required urgent treatment. Anterior debridement and fusion followed by intravenous antibiotics allows for restoration of anterior column support and control of the infection before posterior instrumentation and fusion. Conclusion This study demonstrates that anterior surgical debridement with fusion, followed by a period of intravenous antibiotics and delayed instrumented posterior fusion, is highly effective in the treatment of pyogenic osteomyelitis that has failed medical management.