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Various total disc replacement (TDR) designs have been compared to anterior cervical discectomy and fusion (ACDF) with favorable short and long-term outcomes in FDA-approved investigational device exemption (IDE) trials. The unique design of M6-C, with a compressible viscoelastic nuclear core and an annular structure, has previously demonstrated favorable clinical outcomes through 24 months. To evaluate the long-term safety and effectiveness of the M6-C compressible artificial cervical disc and compare to ACDF at 5 years. Prospective, multicenter, concurrently and historically controlled, FDA-approved IDE clinical trial. Subjects with one-level symptomatic degenerative cervical radiculopathy were enrolled and received M6-C (n=160) or ACDF (n=189) treatment as part of the IDE study. Safety outcomes were evaluated at 5 years for all subjects. The primary effectiveness endpoint was available at 5 years for 113 M6-C subjects and 106 ACDF controls. The primary endpoint of this analysis was composite clinical success (CCS) at 60 months. Secondary endpoints were function and pain (neck disability index, VAS), physical quality of life (SF-36, SF-12), safety, neurologic, and radiographic assessments. Propensity score subclassification was used to control for selection bias and match baseline covariates of the control group to the M6-C subjects. Sixty-month CCS rates were estimated for each treatment group using a generalized linear model controlling for propensity score. At 5 years postoperatively, the M6-C treatment resulted in 82.3% CCS while the ACDF group showed 67.0% CCS (superiority p=.013). Secondary endpoints indicated that significantly more M6-C subjects achieved VAS neck and arm pain improvements and showed maintained or improved physical functioning on quality-of-life measures compared to baseline assessments. The M6-C group-maintained flexion-extension motion, with significantly greater increases from baseline disc height and disc angle than observed in the control group. The rates of M6-C subsequent surgical interventions (SSI; 3.1%) and definitely device- or procedure-related serious adverse events (SAE failure; 3.1%) were similar to ACDF rates (SSI=5.3%, SAE failure=4.8%; p>.05 for both). Subjects treated with the M6-C artificial disc demonstrated superior 5-year achievement of clinical success when compared to ACDF controls. In addition, significantly more subjects in the M6-C group showed improved pain and physical functioning scores than observed in ACDF subjects, with no difference in reoperation rates or safety outcomes. [ABSTRACT FROM AUTHOR]

Study Design: A prospective, randomized, controlled, parallel, single-blinded noninferiority multicenter pivotal FDA IDE trial.Objective: The objective of this study was to investigate efficacy and safety of i-Factor Bone Graft (i-Factor) compared with local autograft in single-level anterior cervical discectomy and fusion (ACDF) for cervical radiculopathy.Summary Of Background Data: i-Factor is a composite bone substitute material consisting of the P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral and suspended in an inert biocompatible hydrogel carrier. P-15 has demonstrated bone healing efficacy in dental, orthopedic, and nonhuman applications.Methods: Patients randomly received either autograft (N = 154) or i-Factor (N = 165) in a cortical ring allograft. Study success was defined as noninferiority in fusion, Neck Disability Index (NDI), and Neurological Success endpoints, and similar adverse events profile at 12 months.Results: At 12 months (follow-up rate 87%), both i-Factor and autograft subjects demonstrated a high fusion rate (88.97% and 85.82%, respectively, noninferiority P = 0.0004), significant improvements in NDI (28.75 and 27.40, respectively, noninferiority P < 0.0001), and high Neurological Success rate (93.71% and 93.01%, respectively, noninferiority P < 0.0001). There was no difference in the rate of adverse events (83.64% and 82.47% in the i-Factor and autograft groups, respectively, P = 0.8814). Overall success rate consisting of fusion, NDI, Neurological Success and Safety Success was higher in i-Factor subjects than in autograft subjects (68.75% and 56.94%, respectively, P = 0.0382). Improvements in VAS pain and SF-36v2 scores were clinically relevant and similar between the groups. A high proportion of patients reported good or excellent Odom outcomes (81.4% in both groups).Conclusion: i-Factor has met all four FDA mandated noninferiority success criteria and has demonstrated safety and efficacy in single-level ACDF for cervical radiculopathy. i-Factor and autograft groups demonstrated significant postsurgical improvement and high fusion rates.Level Of Evidence: 1. [ABSTRACT FROM AUTHOR]

Degenerative spondylolisthesis (DS) with lumbar spinal stenosis (LSS) is commonly treated with decompression and fusion. The LimiFlex Dynamic Sagittal Tether (DST) is an investigational stabilization device for patients with DS and LSS. The purpose of this study is to assess the clinical and radiographic outcomes of decompression and DST compared to transforaminal lumbar interbody fusion (TLIF) for patients with DS and LSS. Multicenter prospective concurrently controlled study. Patients undergoing treatment (decompression and DST or TLIF stabilization) of Grade I Meyerding lumbar degenerative spondylolisthesis. Patients undergoing treatment (decompression and DST or TLIF stabilization) of Grade I Meyerding lumbar degenerative spondylolisthesis. Patients with single-level Grade I DS with LSS were enrolled in the FDA-IDE study (NCT03115983) comparing decompression with DST and decompression with TLIF. Clinical and radiographic outcomes were assessed at baseline and 6-week, 3, 6, 12 and 24-month follow-up. All propensity score (PS) selected patients who had 24-month follow-up were included in this interim analysis. Summary statistics are reported, as well as paired t-tests to assess within-group changes. At 24 months, 228 PS-selected patients (129DST/99TLIF) had clinical follow-up and 197 (117DST/80TLIF) had radiographic follow-up. Mean characteristics of DST and TLIF groupswere: age 65.5/64.1 yrs; BMI 28.1/30.5; CCI 0.43/0.41, respectively. Mean perioperative outcomes for DST/TLIF were: procedure time 112/189 min; EBL 53/232 mL; LOS 0.7/3.2 nights. A significant reduction at 24 months for mean VAS-leg/hip (79.5 to 22.9), VAS-back (66.8 to 19.0) and ODI (52.8 to 13.2) was reported for DST patients (all p < 0.01) with 91% achieving 15-point ODI improvement. TLIF patients demonstrated similar improvements for VAS-leg (80.6 to 24.4), VAS-back (68.1 to 26.1) and ODI (52.3 to 20.9) (all p < 0.01), with 80% achieving 15-point ODI improvement. While there was no difference at baseline, the DST group had lower ODI at all postoperative timepoints. Within the 24 months, 9% of each group had additional surgery at the index or adjacent level. At 24 months, the DST group had mean reductions of 1.7° ROM and 0.4mm translation in flexion/extension images compared to 3.8° and 1.0mm reductions in the TLIF group. Considering the index and adjacent segments together (IAS), the index segment accounted for 30% of IAS ROM at baseline and 27% at 24 months in the DST group compared to 29% at baseline and 13% at 24 months in the TLIF group. These results suggest that decompression with DST stabilization for spondylolisthesis can achieve significant clinical improvement as is expected with fusion, without an increase in reoperations during the 24 months postoperative period. Similarly, statistically significant improvements in patient-reported outcomes were demonstrated in each group, with lower disability scores in the DTB group at all postoperative timepoints. Imaging demonstrated no increased instability in the DST group with maintained distribution of motion between the index and adjacent segments. While these groups were PS-selected, further analyses should include quantitative comparison between groups with PS-adjusted differences per the predefined composite clinical success criteria for a definitive comparison of outcomes. LimiFlex Dynamic Sagittal Tether (Investigational/Not Approved). [ABSTRACT FROM AUTHOR]

Degenerative spondylolisthesis (DS) with lumbar spinal stenosis (LSS) is commonly treated with decompression and fusion. The LimiFlex Dynamic Sagittal Tether (DST) is an investigational stabilization device for patients with DS and LSS. Assess return to work (RTW) and activities of daily living (ADL) receiving either decompression and DST stabilization (D+DST) or decompression and transforaminal lumbar interbody fusion (D+TLIF). Interim analysis from a multicenter, concurrently controlled study. Patients undergoing treatment (D+DST or D+TLIF) of Grade I Meyerding lumbar DS. Propensity score (PS) selected patients with 12-month follow-up were included. Time to RTW and activities of daily living, as well as Oswestry disability index (ODI). PS-selected IDE study subjects with 12 months of follow-up were included in this analysis. Study records queried for work status preoperatively and at 12 months, as well as time to RTW and ADL, and change in disability (Oswestry Disability Index; ODI) at 12 months vs preop. Outcomes were compared using student's t-tests. PS-selected subjects totaled 267 (136 D+DST, 131 D+TLIF). Preoperatively, 49% of D+DST and 43% of D+TLIF subjects were working (p=0.14) and 7% D+DST and 11% D+TLIF were not working due to spinal condition (NWSC) (p=0.13). At 12 months postop, 44% of D+DST and 34% of D+TLIF subjects were working (p=0.05) and 2% D+DST and 10% D+TLIF were NWSC (p<0.01). Proportion of D+DST NWSC was significantly lower 12 months postop compared to preop (p=0.02). Mean±SD RTW time for D+DST/D+TLIF subjects was 5.4±6.6/11.8±9.6 weeks (p<0.01) and return to ADL time was 5.5±6.5/10.0±9.5 weeks (p<0.01). Mean±SD reduction in disability at 12 months from baseline was 38.1±18.4 for the D+DST group and 31.8±20.7 for the D+TLIF group (p<0.01) with effect sizes of -2.1 and -1.5, respectively. The primary objective of surgery for symptomatic DS is resolution of symptoms so patients can return to their normal ADL and work. Both D+DST and D+TLIF treated patients demonstrated a significant reduction in disability at 12-month follow-up. Significantly faster RTW and ADL were observed for D+DST compared to D+TLIF patients, by an average of more than 5 weeks. The proportion of D+DST patients NWSC was significantly less than at 12 months. Results indicate a significant advantage of earlier recovery for the D+DST patients allowing earlier RTW and earlier increase in ADLs compared to D+TLIF, with similar or greater improvements in disability after one year for patients treated with decompression and stabilization for symptomatic DS. Longer-term follow-up assessment with propensity score-adjusted outcomes will demonstrate whether this advantage and long-term outcomes are durable and generalizable. This abstract does not discuss or include any applicable devices or drugs. [ABSTRACT FROM AUTHOR]

The article evaluates the kinematics of the adjacent segments and global cervical spine after cervical arthroplasty compared with anterior cervical discectomy and fusion (ACDF). Results indicate no significant difference in the adjacent segment range of motion (ROM) or centers of rotation with either cervical arthroplasty or ACDF. However, the change in sagittal alignment at the cranial and caudal adjacent segments was significantly more lordotic after arthroplasty compared to ACDF.

Background: The published two-year results of the pivotal U.S. Food and Drug Administration investigational device exemption trial with the use of the Bryan cervical disc arthroplasty compared with anterior cervical discectomy with fusion for treating single-level degenerative cervical disc disease revealed a significantly superior overall success rate in the arthroplasty group. The purpose of this study was to evaluate the midterm safety and effectiveness of the Bryan disc as an alternative to arthrodesis following anterior cervical discectomy. Methods: A prospective, multicenter randomized clinical trial was undertaken for the treatment of persistent radiculopathy or myelopathy due to single-level cervical disc herniations or spondylosis. Patients were randomized to treatment with either the Bryan disc (the arthroplasty group; 242 patients) or anterior cervical discectomy and fusion (the fusion group; 221 patients). Patients completed preoperative and postoperative self-assessment forms at specified intervals and had radiographs made preoperatively, at six weeks, and at three, six, twelve, twenty-four, and forty-eight months after surgery. The primary outcome measure was overall success, a composite variable of safety and efficacy measures. Numerous secondary measures were assessed. The follow-up data for up to twenty-four months have been previously published. We report in the present study the forty-eight-month data collected on 181 patients who received the Bryan disc and 138 patients who underwent anterior cervical discectomy and fusion. Results: The study groups were demographically similar. Substantial reduction in Neck Disability Index scores occurred in both groups compared with preoperative values. The greater improvement in the Neck Disability Index score in the Bryan disc cohort persisted through the four-year follow-up period (p < 0.001). The four-year overall success rates were 85.1% and 72.5% for the arthroplasty and fusion groups, respectively (p = 0.004). The improvement in the arm pain score was substantial for both groups and significantly greater in the Bryan disc cohort (p = 0.028), and the neck pain scores showed persistently greater improvement in the Bryan disc group at forty-eight months of follow-up (p = 0.001). Short Form-36 physical component score improvement remained greater among the Bryan disc cohort (p = 0.007). The mean range of motion for the Bryan disc was 8.08° and 8.48° at twenty-four and forty-eight months, respectively. Total and serious adverse event rates were similar between the groups. Conclusions: The forty-eight-month follow-up data in the present report showed consistent, sustained significantly superior outcomes for cervical spine arthroplasty compared with cervical spine fusion. The arthroplasty cohort continued to show significantly greater improvements in Neck Disability Index, neck pain score, arm pain score, and Short Form-36 physical component score, as well as the primary outcome measure, overall success, at forty-eight months following surgery. [ABSTRACT FROM AUTHOR]

The article offers information on the comparison of results on disc replacement with fusion in the treatment of single-level herniations, overall success, and other outcomes indicating that Bryan cervical disc achieved superior results. It is revealed that cervical disc arthroplasty is a viable alternative to anterior cervical discectomy.

The article discusses a study to compare the rates of adverse events associated with disc arthroplasty versus those of anterior cervical discectomy and arthrodesis with allograft and plate. All the patients were evaluated before and after the surgery. More cervical spine reoperations occurred in the fusion group. Only one spinal cord injury occurred in the arthrodesis group and no patients had deep infection or death related to either procedure.

The article presents a medical research on randomized trial of metal-on-metal artificial lumbar disc replacement. The study represents the first randomized and prospective trial to date of a metal-on-metal artificial lumbar disc replacement for single level degenerative disc disease. Outcome measures revealed comparable results when analyzed against a fusion group, with the benefit of prevention.

The article presents a medical research on the accuracy if intraoperative plain radiographs in detecting violations of intralaminar screws into the C2 vertebrae. The study presented that the overall accuracy for determining intraoperative placement of C2 intralaminar screws averaged 77.4%. It also reveals that with both screws out, the accuracy was only 63.9% which suggest that in over 36% of bilateral screw perforations, plain radiographs cannot detect the violation.

The article examines the success of lumbar decompressions performed on an outpatient basis on patients 65 years of age or older. The results showed that a total of 97 of 134 patients wanted to repeat the outpatient procedure, while 94 of 136 patients said that their surgery's outcome made their condition good or better. The authors suggest that surgical decompression of the lumbar spine can be performed on an outpatient basis, both safely and successfully.

Independent computer-based literature review of articles pertaining to instrumentation and fusion of junctional injuries of the cervical spine.To review and discuss the evolution of instrumentation techniques and systems used in the treatment of cervical spine junctional injuries.Instrumentation of junctional injuries of the cervical spine has been limited historically by failure to achieve rigid internal fixation in multiple planes. The evolution of these techniques has required increased insight into the morphology and unique biomechanics of the structures to be instrumented.Computer-based literature search of Ovid and PubMed databases.Extensive literature search yielded insights into the evolution of systems initially based on onlay bone graft combined with wiring techniques. Such techniques have come to include systems incorporating rigid, longitudinal struts that accommodate multiplanar screws placed in the lateral masses, pedicles, transarticular regions, and occipital bone.Despite a rapid evolution of techniques and instrumentation technologies, it remains incumbent on the physician to provide the patient with a surgical procedure that balances the likelihood of a favorable outcome with the risk inherent in the implementation of the procedure. [ABSTRACT FROM AUTHOR]

Background Context: Translaminar facet screws are a minimally invasive technique for posterior lumbar fixation with good success rates. Computer-assisted image navigation using virtual fluoroscopy allows multiple simultaneous screens in various planes to plan and drive spinal instrumentation. Purpose: This study evaluates the percutaneous placement of translaminar facet screws with the use of virtual fluoroscopy as an image guidance technique. Study Design/setting: A human cadaveric study was performed with a percutaneous reference frame applied to the iliac crest. Ten translaminar facet screws were placed bilaterally at five levels. Anteroposterior and lateral images were used to navigate 4.0-mm screws through a percutaneous portal under virtual fluoroscopy. Methods: An axial computed tomographic scan through the instrumented levels was obtained after the screws were placed. Screws were graded on entry, course through the lamina, and terminus. A grading system was devised to grade the course through the lamina. Results: All 10 screw-entry points were judged optimal at the spinous process laminar junction. There were five Grade I breeches with less than 1/2 the screw through the lamina, and five Grade 0 screw placements with the screw contained completely within the lamina. The termination point was acceptable in five screws. The screws that began on the right and terminated on the left were all found to have grade II breakouts. No screws placed the spinal canal or exiting nerve root at risk. Conclusions: Virtual fluoroscopy provides significant assistance in percutaneous placement of translaminar facet screws and results in safe position of entry, lamina course, and terminus. [ABSTRACT FROM AUTHOR]

Study Design. Prospective randomized controlled trial. Objective. Compare range of motion (ROM) and adjacent segment degeneration (ASD) following cervical disc arthroplasty (CDA) versus anterior cervical discectomy and fusion (ACDF) at 20-year follow-up. Summary of Background Data. Anterior cervical discectomy and fusion is the standard of treatment for single-level cervical disc degeneration causing radiculopathy. CDA is claimed to reduce shear strain, and adjacent-level ROM changes are hypothesized to hasten ASD with ACDF. Materials and Methods. This study collected data on 47 patients randomized to ACDF or CDA. Lateral cervical spine radiographs were evaluated preoperatively, postoperatively, and at 20 years for alignment, ROM, ASD, and heterotopic ossification. Results. Eighty-two percent (18/22) of CDA patients and 84% (21/25) of ACDF patients followed up at 20 years. At 20 years, total cervical (C2--C7) ROM was statistically different between the CDA and fusion groups (47.8° vs. 33.4°, P=0.005). Total cervical ROM was not significantly different between preoperative and 20-year periods following CDA (45.6° vs. 47.4°, P=0.772) or ACDF (40.6° vs.33.0°, P=0.192). Differences in postoperative and 20-year index-level ROM following CDA were not significant (10.1° vs. 10.2°, P=0.952). Final ASD grading was statistically lower following CDA versus ACDF at both adjacent levels (P<0.005). Twenty-year adjacent-level ossification development was increased following ACDF versus CDA (P<0.001). Polyethylene mean thickness decreased from 9.4 mm immediately postoperatively to 9.1 mm at 20-year follow up (P=0.013). Differences in adjacent-level ROM from preoperative to 20-year follow-up in both the ACDF and CDA groups did not meet statistical significance (P>0.05). Conclusions. Cervical disc arthroplasty maintains index-level and total cervical ROM with very long-term follow-up. Total cervical ROM was higher at 20 years in CDA relative to ACDF. CDA results in lower rates of ASD and adjacent-level ossification development than ACDF. [ABSTRACT FROM AUTHOR]

Case: A 61-year-old woman with recurrent left L5 radiculopathy underwent revision L4-5 decompression complicated by incidental durotomy requiring primary repair. Postoperative course was complicated by wound drainage and headache. Repeat magnetic resonance imaging demonstrated cerebrospinal fluid dissecting a plane deep to the dura mater but superficial to the arachnoid, with the collection compressing the cauda equina in an atypical horizontal and linear fashion. Nonoperative treatment was ineffective, and she required revision decompression and dural repair. Conclusion: Spine surgeons should recognize this finding on postoperative imaging as a potential sign of an incomplete dural repair necessitating return to the operating room. [ABSTRACT FROM AUTHOR]

BACKGROUND CONTEXT Thirty percent of Americans have low back pain (LBP) at any given time, leading to approximately 50 million physician visits in the U.S. annually. For patients with chronic low back pain (CLBP), the etiology can be difficult to diagnose and then treat using either current nonsurgical therapies, with inherent patient adherence challenges, or surgical interventions, with associated long recovery times. Antonacci et al, following anatomic study, proposed that a portion of pain previously ascribed to the disc actually emanates from the vertebral body endplate nociceptors which communicate to the central nervous system (CNS) through the basivertebral nerve (BVN). We report on the two-year outcome data of the treatment arm patients in the SMART trial, which studied RF BVN ablation to treat CLBP. PURPOSE To determine the longer term efficacy of basivertebral nerve ablation, for the treatment of chronic low back pain. STUDY DESIGN/SETTING Prospective, randomized, double-blinded, sham control study that was an FDA approved clinical trial. Fifteen sites in the US and three in Germany participated. PATIENT SAMPLE Skeletally mature patients with chronic (>6 months), isolated low back (lumbar) pain and no neurogenic leg pain, who had not responded to at least six months of nonoperative management (conservative care) were eligible for the SMART study. Recent MRI had to demonstrate either Type 1 or 2 Modic changes at three or less contiguous vertebral bodies. OUTCOME MEASURES ODI, Safety, VAS. METHODS A total of 128 patients, from the per-protocol treatment arm of the SMART trial, a double-blind sham-controlled randomized trial, were followed for up to 24 months. ODI and VAS instruments were used to collect patient reported outcomes at baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months. RESULTS ODI and VAS data were available on 106 and 104 patients at 24 months respectively. The mean baseline ODI in the treatment arm was 42.4, decreasing to 22.6 at 12 months and 18.8 at 24 months. The mean baseline VAS in the treatment arm was 6.73, decreasing to 3.96 at 12 months and 3.13 at 24 months. Using a paired t -test comparing the 12 and 24-month VAS observations, the mean score at 24 months was significantly improved compared to 12 months (3.80 vs. 3.13, p=.004). CONCLUSIONS The SMART trial demonstrates that BVN ablation is statistically and clinically superior to the sham intervention, and that the degree of ODI improvement is approximately one disability category. Longitudinal follow-up of these patients demonstrates that ablation of the BVN for the relief of CLBP is a durable procedure with continuing improvement in patient reported ODI and VAS scores at up to two years. FDA DEVICE/DRUG STATUS Intracept System (Approved for this indication). [ABSTRACT FROM AUTHOR]

Background Context: Various designs of total disc replacement (TDR) devices have been compared to anterior cervical discectomy and fusion (ACDF) with favorable outcomes in FDA-approved investigational device exemption trials. The design of M6-C with a compressible viscoelastic nuclear core and an annular structure is substantially different than prior designs and has previously demonstrated favorable kinematics and clinical outcomes in small case series.Purpose: To evaluate the safety and effectiveness of the novel M6-C compressible artificial cervical disc compared with ACDF for subjects with single-level degenerative cervical radiculopathy.Study Design/setting: Prospective, multicenter, concurrently and historically controlled, FDA-approved investigational device exemption clinical trial.Patient Sample: Subjects with one-level symptomatic degenerative cervical radiculopathy were enrolled and assigned to receive M6-C or ACDF.Outcome Measures: Pain and function (Neck Disability Index, VAS), quality of life (SF-36), safety, neurologic, and radiographic assessments of motion (both flexion extension and lateral bending) were performed. The primary clinical endpoint was composite clinical success (CCS) at 24 months.Methods: Using propensity score subclassification to control for selection bias, 160 M6-C subjects were compared to a matched subset of 189 ACDF controls (46 concurrent and 143 historical controls).Results: Both ACDF and M6-C subjects reported significant improvements in patient-reported outcomes at all time points over baseline. Overall SF-36 Physical Component Score and neck and arm pain scores were significantly improved for M6-C as compared to ACDF treatment. CCS and mean Neck Disability Index improvements were similar between M6-C and ACDF. Correspondingly, there were significantly fewer subjects that utilized pain medication or opioids following M6-C treatment at 24 months relative to baseline. Range of motion was maintained in subjects treated with M6-C. Subsequent surgical interventions, dysphagia rates, and serious adverse events were comparable between groups.Conclusions: M6-C treatment demonstrated both safety and effectiveness for the treatment of degenerative cervical radiculopathy. Treatment with M6-C demonstrated noninferiority for the primary endpoint, indicating a similar ability to achieve CCS at 24 months. However, for the secondary endpoints, M6-C subjects demonstrated significantly improved pain and function compared to ACDF subjects, while maintaining range of motion, improving quality of life, and decreasing analgesic and opioid usage at 2 years postoperatively relative to baseline. [ABSTRACT FROM AUTHOR]

In this article, the author reflects on a research related to treatment of cervical radiculopathy by anterior cervical discectomy and fusion (ACDF). Topics discussed include frequent adjacent-level degeneration as compared to arthroplasty, satisfactory results shown for cervical arthroplasty in clinical trials, and cervical fusion expected to be supplanted by cervical radiculopathy.

Purpose of study: Autogenous iliac crest bone graft is the gold standard for bone grafting for spinal fusion surgery. Unfortunately, there is a frequent incidence of graft site pain that persists well into the postoperative period. This study reports the results of a prospective study evaluating graft site pain after iliac crest harvest for anterior lumbar interbody fusion (ALIF). Methods used: A total of 208 patients underwent iliac crest bone graft for ALIF as the control group of four randomized prospective multicenter clinical trials evaluating recombinant human bone morphogenic protein (rhBMP)-2 vs autogenous iliac crest bone graft in a threaded cylindrical cages or threaded bone dowels. Most patients in the control groups had anterior iliac crest graft harvest, equally from the right and left side. Three grafts, 1.4%, were taken from the posterior crest, and six, 2.9%, were tricortical. Follow-up was obtained at hospital discharge, 6 weeks, 3, 6, 12 and 24 months. A pain evaluation score made up of two visual analog scales, one scale measuring intensity, the other frequency of pain on a scale of 0 to 10, was used. For the intensity scale, a rating of 0 meant no pain and 10 was “as bad as it could be.” For the frequency scale, a rating of 0 meant pain was present “none of the time” and 10 meant it was present “all the time.” Combining the scores, a total score of 20 indicated the worst pain was present all the time. Patients were also questioned about the graft site appearance. of findings: A total of 208 patients underwent iliac crest harvest and prospective data were available on 202 patients. At hospital discharge, two patients had no pain, 1%; this increased to 34 of 199, 17%, at 6 weeks after surgery and to 85 of 199 patients, 43%, at 3 months. However, 41% of patients (79 of 192) reported pain at 6 months postoperatively, and 33% of 168 reported pain at 1 year. Of 208 patients, 141 completed surveys at 24 months with 31% reporting some level of pain. At hospital discharge, the graft-site pain score ranged from 0 to 20 with a mean of 12.8, SD 4.5, decreasing to 7.3, (SD, 5.6; range, 0 to 20) at 6 weeks; 3.8 (SD, 4.6; range, 0 to 18) at 3 months; and scores of 2.9, 2.4 and 1.8 at 6, 12 and 24 months, respectively. At all time intervals p values were less than .001. Total pain scores combining intensity and frequency greater than or equal to 10, maximum possible 20, were collected at each interval. At discharge 80% (161 of 202) had a pain score of less than 10 (range, 10 to 20). This decreased to 35% (70 of 199; range, 10 to 20) at 6 weeks; 14% (28 of 199 at 3 months; range, 10 to 18); and at 6, 12 and 24 months postoperatively, 13% (25 of 192), 10% (17 of 168) and 7% (10 of 141) respectively. Graft site appearance at discharge was good in 49% of patients, fair in 40% and poor in 11%. At 6 weeks, 69% rated appearance as good, 27% as fair, 5% as poor. At 3 months 75% rated appearance as good, 24% as fair, 2% as poor. At 6 months 82% rated appearance as good, 15% as fair, 3% as poor. At 12 months 82% rated appearances as good, 19% as fair or poor. At 24 months 84% rated appearances as good and 16% as fair or poor. There was no significant difference between posterior and anterior harvest sites or with bicortical grafts, and all were included in the analysis. Right or left side demonstrated no differences. Relationship between findings and existing knowledge: This is the first study known to the authors presenting results of prospective data collected in a multicenter study evaluating iliac crest harvest site pain (intensity and frequency) as well as graft site appearance. Overall significance of findings: The results demonstrate that 31% of patients had persistent pain at 24 months postoperatively, and 16% reported fair or poor appearance of their graft site. Disclosures: No disclosures. Conflict of interest: Rick Sasso, grant research support and, consultant. [ABSTRACT FROM AUTHOR]

There remains significant controversy regarding the use of a vertebral selective nerve root injection (SNI) as a diagnostic and therapeutic tool. In addition, the frequency of use of such procedures in patients with radiculopathy has increased dramatically in the last few years. Based on a Medline review there has been no studies combining cervical and lumbar SNI results and comparing preoperative diagnosis to surgical findings and outcome. The purpose of this paper is to retrospectively examine and compare the sensitivity, specificity and predictive value of a good surgical outcome in patients who had an SNI and subsequent surgical intervention. 101 patients from a 1996 thru 1999 database, who were referred to 10 spine surgeons (2 orthopedic and 8 neurosurgeon) for either cervical or lumbar radiculopathy, and had SNI and various imagery studies and subsequent surgery. Patients receive SNIs at our institution if there is a discrepancy between physical exam and radiologic imagery or to confirm a putative pain generator in multilevel pathology. These patients were then retrospectively analyzed with regard to correlation to surgical level and surgical outcome. SNIs were performed by one of three pain specialists in our clinic. Approximation of the appropriate nerve root sleeve was performed using fluoroscopic imagery, a nerve stimulator and contrast. After nerve root stimulation and neurography, 0.5–0.75 cc of lidocaine 2% was injected. Pre- and post-procedural visual analog scale (VAS) pain scores were obtained from the non-sedated patient. A SNI was considered positive or negative if the patient had immediate appendicular pain relief of greater or less then ninety percent respectively. The study was designed to include only those patients that had a SNI, regardless of result, and subsequently had surgical decompression in an attempt to treat the pain that initially prompted the SNI. A statistical analysis was then performed comparing preoperative data to... [ABSTRACT FROM AUTHOR]

A response by Rick Sasso and colleagues to a letter to the editor about their article "Artificial disc versus fusion. A prospective, randomized study with 2-years follow-up on 99 patients," is presented.

Cervical spine injury classification systems are essential to allow the precise description of fractures, which facilitates communication between physicians, determines prognosis, directs treatment, and assesses outcomes. Little new information is available regarding the diagnosis, treatment, and prognosis of patients with odontoid fractures. These elderly patients with a Type 2 odontoid fracture have a higher risk of complications including mortality. [Extracted from the article]

Abstract: Background context: The rationale for motion preservation by disc replacement after anterior cervical discectomy is to diminish long-term morbidity secondary to adjacent segment degeneration. However, these disc prostheses will be subject to wear and its possible adverse consequences. Purpose: Assess the in vitro and in vivo wear properties of the Bryan Cervical Disc and the early clinical results. Study design: In vitro mechanical testing, caprine animal model and prospective European human trial. Outcome measure: In vitro mechanical testing used American Society for Testing and Materials standards to measure wear rates and debris. Caprine results were analyzed by histopathologic analysis by a blinded veterinary pathologist. Clinical outcomes were measured by Odoms''s criteria, independent radiologic analysis and Short Form–36. Methods: In vitro wear testing in cervical spine simulator for up to 40 M cycles. Wear rates were determined and particles analyzed microscopically. The in vivo inflammatory response was studied in goats that had discectomy at C4–C5. They were sacrificed between 3 and 12 months and histopathologically were compared with controls who had fusions with titanium plates. A prospective clinical trial of 136 patients with minimum 1-year follow-up was analyzed using validated questionnaires and radiographs. Results: In vitro wear averaged approximately 1.76% by weight at 10 M cycles and 18% at 40 M cycles. Wear debris were present in the periprosthetic tissues in 4 of 11 animals without inflammatory response. The early clinical results were satisfactory in over 90% of patients. Conclusion: The in vivo and in vitro wear properties are satisfactory for the expected duration of life of the prosthesis. The early clinical results are satisfactory and equal to fusion. [Copyright &y& Elsevier]

Abstract: Background context: The rationale for motion preservation by disc replacement after anterior cervical discectomy is to diminish long-term morbidity secondary to adjacent segment degeneration. However, these disc prostheses will be subject to wear and its possible adverse consequences. Purpose: Assess the in vitro and in vivo wear properties of the Bryan Cervical Disc and the early clinical results. Study design: In vitro mechanical testing, caprine animal model and prospective European human trial. Outcome measure: In vitro mechanical testing used American Society for Testing and Materials standards to measure wear rates and debris. Caprine results were analyzed by histopathologic analysis by a blinded veterinary pathologist. Clinical outcomes were measured by Odoms''s criteria, independent radiologic analysis and Short Form–36. Methods: In vitro wear testing in cervical spine simulator for up to 40 M cycles. Wear rates were determined and particles analyzed microscopically. The in vivo inflammatory response was studied in goats that had discectomy at C4–C5. They were sacrificed between 3 and 12 months and histopathologically were compared with controls who had fusions with titanium plates. A prospective clinical trial of 136 patients with minimum 1-year follow-up was analyzed using validated questionnaires and radiographs. Results: In vitro wear averaged approximately 1.76% by weight at 10 M cycles and 18% at 40 M cycles. Wear debris were present in the periprosthetic tissues in 4 of 11 animals without inflammatory response. The early clinical results were satisfactory in over 90% of patients. Conclusion: The in vivo and in vitro wear properties are satisfactory for the expected duration of life of the prosthesis. The early clinical results are satisfactory and equal to fusion. [Copyright &y& Elsevier]

Purpose of study: One of the most devastating complications of anterior lumbar interbody fusion (ALIF) in the young male patient is retrograde ejaculation. The purpose of this study is to compare the incidence of retrograde ejaculation in a group of patients undergoing ALIF through either a transperitoneal or retroperitoneal approach. Methods used: A total of 279 patients were entered into a randomized, prospective US Food and Drug Administration investigational device exemption (IDE) study evaluating recombinant human bone morphogenic protein (rhBMP)-2 in a tapered titanium cylindrical cage placed through an open anterior approach for treatment of symptomatic degenerative disc disease. Choice of retroperitoneal or transperitoneal approach was at the surgeon's discretion. All procedures were at the L4–L5 or L5–S1 level. The investigation group received rhBMP-2 and the control group autograft iliac crest bone in the cage. Of the 143 patients in the rhBMP-2 group, 78 were male. A retroperitoneal approach was performed on 61 and transperitoneal on 17. In the control group, 68 of 136 patients were male. Fifty-five had a retroperitoneal approach, and 13 had a transperitoneal approach. There is no reported influence of type of bone graft on retrograde ejaculation, so the groups were combined for evaluation. A total of 146 male patients were included in this study with 116 undergoing a retroperitoneal approach and 30 a transperitoneal approach. All male patients were advised preoperatively of the risk of retrograde ejaculation. Patients were questioned postoperatively about adverse events. If a patient reported retrograde ejaculation had occurred postoperatively, they were questioned at each subsequent visit to determine if it was a transient or permanent condition. of findings: Six of 146 male patients reported retrograde ejaculation. Two occurred in the retroperitoneal group (2 of 116) for a 1.7% rate. Four occurred in the transperitoneal group (4 of 30) for a 13.3% rate. This was statistically significant using the Fisher's exact test (p=.017). One patient who developed retrograde ejaculation had an L4–L5 fusion using a retroperitoneal approach and five had an L5–S1 fusion, four with a transperitoneal approach and one with a retroperitoneal approach. Two patients had resolution of their condition at the 1-year postoperative interval, one from the retroperitoneal group and one from the transperitoneal approach. One patient with transient symptoms had an L4–L5 fusion through the retroperitoneal approach, and one patient had an L5–S1 fusion through a transperitoneal approach. At the 2-year postoperative evaluation, four patients had persistent retrograde ejaculation. One was in the retroperitoneal group (1 of 116) for a rate of 0.86% and three in the transperitoneal group (3 of 30) for a rate of 10%. The difference in the rate of permanent retrograde ejaculation is statistically significant between the retroperitoneal and transperitoneal groups using the Fisher's exact test (p=.027) Relationship between findings and existing knowledge: The first reports of retrograde ejaculation after ALIF were made in the 1960s. Although a rare complication, concern arose in the 1990s when a higher rate was noted with laparoscopic procedures. The results of this study show a statistically significant higher rate of permanent retrograde ejaculation in men undergoing a transperitoneal compared with a retroperitoneal approach (10% vs. 0.86%). Overall significance of findings: Transperitoneal approaches to the lumbar spine at L4–L5 and L5–S1 have a 10 times higher chance of retrograde ejaculation compared with retroperitoneal approaches in male patients. Disclosures: No disclosures. Conflict of interest: Rick Sasso, MD, grant research support; Rick Sasso, MD, consultant; Kenneth Burkus, MD, grant research support; Kenneth Burkus, MD, consultant; Jean Charles LeHuec, MD, grant research support; Jean Charles LeHuec, MD, consultant. [ABSTRACT FROM AUTHOR]

Abstract: Background context: Occipital condyle screws appear to be a novel technique that demands biomechanical consideration. It has the potential to achieve fixation anterior to the axis of rotation while offering a point of fixation in line with the C1/C2 screws. Purpose: To compare the segmental stability and range of motion (ROM) of standard occipitocervical (OC) screw/rod and plate constructs versus a new technique that incorporates occipital condyle fixation. Study design: Human cadaveric biomechanical analysis. Methods: After intact analysis, 10 fresh-frozen human cadaveric OC spine specimens were instrumented bilaterally with C1 lateral mass screws and C2 pedicle screws. Additional occipital instrumentation was tested in random order under the following conditions: standard occipitocervical plate/rod system (Vertex Max; Medtronic, Inc., Minneapolis, MN, USA); occipital condyle screws alone; and occipital condyle screws with the addition of an eyelet screw placed into the occiput bilaterally. After nondestructive ROM testing, specimens were evaluated under computed tomography (CT) and underwent destructive forward flexion failure comparing Group 1 to Group 3. Results: There was no significant difference in OC (Occiput–C1) axial rotation and flexion/extension ROM between the standard occipitocervical plate/rod system (Group 1) and the occipital condyle screws with one eyelet screw bilaterally (Group 3). Furthermore, the occipital condyle screws alone (Group 2) did allow significantly more flexion/extension compared with Group 1. Interestingly, the two groups with occipital condyle screws (Groups 2 and 3) had significantly less lateral bending compared with Group 1. During CT analysis, the mean occipital condyle width was 10.8 mm (range, 9.1–12.7 mm), and the mean condylar length was 24.3 mm (range, 20.2–28.5). On destructive testing, there was no significant difference in forward flexion failure between Groups 1 and 3. Conclusions: With instrumentation across the mobile OC junction, our results indicate that similar stability can be achieved with occipital condyle screws/eyelet screws compared with the standard occipitocervical plate/rod system. [Copyright &y& Elsevier]

The article offers a study that evaluates the biomechanical stability of segmental occipitoatlantoaxial (C0-C1-C2) stabilization techniques. The six human cadaveric cervical spines instrumented with 3 different techniques were compared. Results showed that the 3 stabilization techniques decreased range of motion in the C0-C2 compared to the intact spine. It concludes that the techniques that use C2 crossing laminar screws, pedicles screws, and C1-C2 transarticular screws have similar stability.

The article presents a study that compared cervical spine surgery to total hip and knee arthroplasty using SF-36, a patient-derived questionnaire. After performing a meta-analysis of SF-36 outcomes of total hip and knee arthroplasty, the results were compared to cervical discectomy and arthroplasty or fusion. It was found that the SF-36 results showed equal or greater short-term improvement in cervical spine patient's pain and function than that observed after joint arthroplasty.