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Longitudinal cohort.To investigate whether patients with painful adolescent idiopathic scoliosis experience pain relief with surgical treatment.Adolescent idiopathic scoliosis (AIS) was previously thought to be a painless condition, but recent studies have shown that a significant proportion of patients have pain. Little information is available regarding pain relief with surgical treatment for AIS.Patients enrolled in a prospective database of surgically treated AIS were divided into two groups based on their preoperative Scoliosis Research Society (SRS)-22R pain domain score. Patients with a preoperative pain domain score of 4 or more (N = 1005) were classified as nonpainful. If the preoperative pain domain score was less than 4 (N = 505), they were classified as painful. Demographics, SRS total and domain scores, and changes with treatment were compared for the two groups.The two groups had similar demographics and preoperative coronal curve magnitude. Patients with painful scoliosis experienced significant improvement in SRS-22R pain scores, from 3.29 preoperatively to 4.03 postoperatively (P 0.000). Eighty-one percent of these patients reached the minimum clinically important difference threshold (0.20) for improvement in pain score. Painful scoliosis patients also had greater 2-year improvement in total and all domain scores than the nonpainful scoliosis patients (P 0.000). Absolute values of SRS-22R total and domain scores were all greater at 2 years in the nonpainful group than the painful group.Patients with AIS with substantial back pain can be cautiously counseled to expect significant improvement in pain level with surgical correction of their deformity, even if curve progression is the primary indication for surgery. Although these patients achieve greater improvements in health-related quality of life compared with patients with mild or no pain, 2-year SRS-22R scores were still better in patients with mild or no pain preoperatively.2.

Study design: Retrospective review. Objective: To identify risk factors for cell saver transfusion in lumbar spinal surgery and determine if cell saver transfusions affected intraoperative or postoperative transfusion rates. Summary of background data: Cell saver has been used to minimize allogeneic blood transfusion in lumbar spinal surgery. Conflicting reports exist, which call into question the efficacy of cell saver use. Methods: We reviewed medical records of randomly selected patients who underwent posterolateral fusion with or without transforaminal interbody fusion from July 2010 to June 2011. Transfusion rates and transfusion-related complications were determined. Binary logistic regression was performed to identify risk factors for use of autologous cell saver transfusion. Results: There were 178 females and 107 males, with a mean age of 57.2 years. Of the 285 cases, 39 had no cell saver available, 147 had cell saver available but no autologous blood was recovered or transfused and 99 had an autologous cell saver transfusion. Patients who had cell saver transfusion had a higher rate of intraoperative allogeneic blood transfusion (52%) compared with those who did not (22%). There was no significant difference in the rate of postoperative transfusions or transfusion-related reactions between patients who did and did not have cell saver transfusion. Patient's age, smoking status, American Society of Anesthesiologists grade, use of anticoagulants preoperatively, primary or revision surgery, iliac crest bone graft harvest, anesthesiologist, or surgeon had no significant effect on cell saver infusion. Body mass index (odds ratio [OR] = 1.06), number of posterolateral fusion levels fused (OR = 2.50), and number of transforaminal interbody fusions performed (OR = 2.41) were independent risk factors for the use of autologous cell saver transfusion. Conclusion: Body mass index, multi-level fusion and transforaminal interbody fusion result in increased use of autologous cell saver transfusion in lumbar spinal surgery. Use of autologous cell saver transfusion did not reduce the requirement for intraoperative or postoperative allogeneic blood transfusion. Level of evidence: 2.

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.

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.

STUDY DESIGN This report describes a case of vertebral body osteonecrosis associated with the use of intradiscal electrothermal therapy. OBJECTIVES To alert clinicians to a previously unreported complication, vertebral body osteonecrosis, after an intradiscal electrothermal therapy procedure. SUMMARY OF BACKGROUND DATA The intradiscal electrothermal therapy procedure is a new treatment that has been advocated in the management of chronic low back pain of discogenic origin. The intradiscal electrothermal therapy procedure uses a fluoroscopically guided thermal catheter to heat the intervertebral disc. A review of the literature regarding this procedure has not revealed osteonecrosis as a complication. METHODS The patient's work-up and postoperative course are documented, and all medical records were reviewed retrospectively. RESULTS The patient's pain had improved only minimally at initial follow-up after L5-S1 combined anterior and posterior spinal fusion, undertaken after intradiscal electrothermal therapy failure. CONCLUSIONS Intradiscal electrothermal therapy has gained increasing popularity in the treatment of discogenic low back pain, in large part because of its minimally invasive nature and perceived low risk for major complications. Previous reports in the literature have not noted any major complications associated with the proper use of this device. Clinicians should be advised that intradiscal electrothermal therapy can be associated with complications, which in the current case, led to osteonecrosis of the vertebral body.

Study design Retrospective review. Objective To determine the incremental cost-effectiveness of cell saver for single-level posterior lumbar decompression and fusion (PLDF). Summary of background data Intraoperative cell salvage is used during surgery to reduce the need for perioperative allogeneic blood transfusion. Although the use of cell saver may be beneficial in certain circumstances, its utility has not been clearly established for the common procedure of an adult single-level PLDF. Methods Randomly selected adult patients treated with a single-level PLDF between July 2010 and June 2011 at a single institution were identified. Patients who had a combined anterior and posterior approach were excluded. The final study sample for analysis consisted of 180 patients. Hospital records were reviewed to determine whether: (1) cell saver was available during surgery, (2) recovered autologous blood was infused, and (3) the patient received intra- or postoperative allogeneic transfusions. Estimated blood loss, levels fused, volume(s) transfused, and all related complications were recorded. Costs included the cost of allogeneic blood transfusion, setting up the cell saver recovery system, and infusing autologous blood from cell saver, whereas effectiveness measures were allogeneic blood transfusions averted and quality adjusted life years. Results The incremental cost-effectiveness ratio was $55,538 per allogeneic transfusion averted, with a decrease in the transfusion rate from 40.0% to 38.7% associated with the cell saver approach. This translated into an incremental cost-effectiveness ratio of $5,555,380 per quality adjusted life years gained, which is well above the threshold for an intervention to be considered cost-effective ($100,000 per quality adjusted life years gained). Conclusion The use of cell saver during a single-level PLDF does not significantly reduce the need for allogeneic blood transfusion and is not cost-effective. The high cost of cell saver in combination with the low complication rate of allogeneic blood transfusion, suggest that cell saver should not be used for single-level PLDF. Further studies are needed to evaluate the necessity for cell saver among other types of spinal surgery.

Study design Longitudinal cohort. Objectives To determine the discriminate validity of the Short Form-6D (SF-6D) compared with the SF-36 in a cohort of patients with lumbar degenerative disorders. Summary of background data Cost-utility studies are important for the demonstration of comparative effectiveness of treatments for lumbar degenerative disorders. Multidimensional patient-reported outcome tools including the SF-36 and Oswestry Disability Index (ODI) may be limited to measuring the utility of specific health care states. The evaluation of utility is based on single-index preference-based health state scales, such as the SF-6D. The loss of discriminative properties using a single-index compared with a multidimensional score is unknown. Methods The cohort studies included 1104 patients who had decompression and lumbar fusion with complete ODI, SF-36, and SF-6D data at baseline and 2-year follow-up. Discriminative properties of the 3 measures were compared by computing the effect size (ES) and the standardized response mean (SRM). The larger the ES and SRM, the more sensitive to change the measure is. The relative validity (RV) statistic for each measure was also determined with the SF-6D as reference. Measures that are more sensitive than the SF-6D would have RVs greater than 1.0, those that are less sensitive would have RVs less than 1.0. Results The ODI had the greatest ES at 0.93 followed by the SF-6D at 0.88 and the SF-36 Physical Composite Score (PCS) at 0.85. The ODI also had the greatest standardized response mean at 0.73 followed by the SF-6D at 0.70 and the SF-36 PCS at 0.57. The RV statistics for both the ODI (1.28) and the SF-36 PCS (1.32) were greater compared with the SF-6D. The SF-36 bodily pain domain had the greatest ES (1.42), SRM (0.81), and RV (1.50). The general health domain had the lowest ES (0.21) and SRM (0.23), whereas mental health domain had the lowest RV. Conclusions In this cohort of patients, using the single-index SF-6D produces a loss of discriminative properties compared with the SF-36 and ODI. However, this loss is small, because all the effect sizes remain large (≥0.80). Therefore, these losses should not preclude the use of the SF-6D compared with the SF-36 and may be preferred because it is more easily interpretable and less difficult to incorporate in economic evaluations.

STUDY DESIGN Longitudinal cohort. OBJECTIVE To present Oswestry Disability Index scores and SF-6D utility values among patients with different diagnostic etiologies who underwent fusion surgery. SUMMARY OF BACKGROUND DATA Several studies have increased our understanding of health-related quality-of-life measures in patients with low back pain. With rising health care costs, cost-utility analysis is increasingly used by decision makers. Thus, clinicians and researchers need to understand the psychometrics and clinical importance of health state utility values in patients with spine disorders. METHODS A total of 1104 patients who had decompression and lumbar fusion with complete data to compute the SF-6D score at baseline and 2-year follow-up were identified. Primary surgical cases were classified as disc pathology (n = 200), spondylolisthesis (n = 288), instability (n = 43), stenosis (n = 134), or scoliosis (n = 44). Revision cases were classified as nonunion (n = 94), adjacent-level degeneration (n = 98), or postdiscectomy revision (n = 203). Baseline SF-6D and change in SF-6D scores at 2 years were compared among the groups as well as primary versus revision cases. RESULTS There were 674 women and 430 men. The mean age at surgery was 56.65 ± 12.7 years. There were 220 (19.9%) smokers. The worst mean baseline SF-6D score was in patients with nonunion (0.492), followed by disc pathology (0.493), adjacent-level degeneration (0.494), postdiscectomy revision (0.499), stenosis (0.504), instability (0.512), spondylolisthesis (0.520), and scoliosis (0.530). There was a statistically significant difference in baseline SF-6D score among the different groups (P = 0.002). The mean change in SF-6D score was greatest in patients with stenosis (0.088), followed by spondylolisthesis (0.085), scoliosis (0.076), disc pathology (0.076), instability (0.073), postdiscectomy revision (0.070), adjacent-level degeneration (0.066), and nonunion (0.050). There was no statistically significant difference in change in SF-6D score among the different groups (P = 0.096). However, revision cases had statistically significantly smaller gains in SF-6D score (0.064) than primary cases (0.082, P = 0.012). CONCLUSION Patients with lumbar degenerative disorders have health state values similar to patients with chronic renal disease, Crohn's disease, or coronary artery disease. Health state values of patients with different indications for surgery differ at baseline and after surgery. Revision cases have worse baseline SF-6D scores and less improvement in scores at 2 years after surgery than primary cases. Further studies are needed to gain a greater understanding of health state utility values in patients with lumbar degenerative disorders.

Study Design. Prospective cohort. Objectives. The purpose of this study is to examine the relationship between radiographic fusion and patient-reported health-related quality of life (HRQOL) measures in patients undergoing instrumented posterolateral lumbar fusion. Summary of Background Data. Previous studies have shown that a solid fusion does not always produce clinical success. However, these studies did not use validated patient-reported HRQOL measures. Methods. One hundred ninety-three patients who underwent instrumented posterolateral fusion with complete preoperative and 2-year HRQOL measures and a fine-cut computed tomographic (CT) scan with reconstructions done at 2 years after surgery specifically done to assess fusion status were identified. HRQOL measures included the Oswestry Disability Index (ODI), the Short Form-36 and back and leg pain numerical rating scales. The percentage of patients reaching the minimum clinically important difference and substantial clinical benefit for ODI and Short Form-36 were also calculated. CT scans were graded as fused or not by three independent reviewers. Comparisons were made in outcomes measures between the patients with solid fusions and those judged not to have a solid radiographic fusion. Results. There were 124 women and 69 men with an average age of 63 years. Patients judged to have a solid fusion demonstrated a better ODI score at 2 years than those who were not solidly fused (P = 0.023). There was a trend toward greater improvement in mean ODI score in those with a solid fusion (P = 0.074). A statistically greater number of patients who had a solid fusion (111 of 171, 65%) achieved the minimum clinically important difference for ODI than those who did not achieve a solid fusion (7 of 22, 32%) (P = 0.004). Conclusion. A greater proportion of patients achieved clinically relevant improvements in low back specific quality-of-life measures when they had achieved a solid fusion than patients who did not have a solid fusion. Although radiographic fusion may not be the true measure of clinical success, this study suggests that solid arthrodesis contributes to clinical outcome and is an important goal of fusion surgery.

Study Design. Cross-sectional cohort. Objective. This study aims to provide an algorithm to estimate Short Form-6D (SF-6D) utilities using data from the Neck Disability Index (NDI), neck pain, and arm pain scores. Summary of Background Data. Although cost-utility analysis is increasingly used to provide information about the relative value of alternative interventions, health state values or utilities are rarely available from clinical trial data. The Neck Disability Index (NDI) and numerical rating scales for neck and arm pain are widely used diseasespecific measures in patients with cervical degenerative disorders. The purpose of this study is to provide an algorithm to allow estimation of SF-6D utilities using data from the NDI, and numerical rating scales for neck and arm pain. Methods. SF-36, NDI, neck and arm pain rating scale scores were prospectively collected before surgery, at 12 and 24 months after surgery in 2080 patients undergoing cervical fusion for degenerative disorders. SF-6D utilities were computed, and Spearman correlation coefficients were calculated for paired observations from multiple time points between NDI, neck and arm pain scores, and SF-6D utility scores. SF-6D scores were estimated from the NDI, neck and arm pain scores were estimated using a linear regression model. Using a separate, independent dataset of 396 patients in which NDI scores were available, SF-6D was estimated for each subject and compared to their actual SF-6D. Results.The mean age for those in the development sample was 50.4 ± 11.0 years and 33% were male. In the validation sample, the mean age was 53.1 ± 9.9 years and 35% were male. Correlations between the SF-6D and the NDI, neck and arm pain scores were statistically significant (P < 0.0001) with correlation coefficients of 0.82, 0.62, and 0.50, respectively. The regression equation using NDI aloneto predict SF-6D had an R 2 of 0.66 and a root mean square error of 0.056. In the validation analysis, there was no statistically significant difference (P = 0.961) between actual mean SF-6D (0.49 ± 0.08) and the estimated mean SF-6D score (0.49 ± 0.08), using the NDI regression model. Conclusion.This regression-based algorithm may be a useful tool to predict SF-6D scores in studies of cervical degenerative disease that have collected NDI but not utility scores.

Study design Retrospective cohort analysis. Objective To investigate health-related quality of life improvements in patients undergoing lumbar fusion to revise a previous lumbar spine surgery. Summary of background data Spinal fusion is often used as a surgical intervention in patients who have previously undergone lumbar surgery. Prior studies suggest results that are inferiorto primary fusions. However, most of these studies are based on subjective surgeon evaluations, lack patient-reported outcomes, and include various diagnoses such as prior discectomy, adjacent level degeneration, and nonunion. Methods From a single-center database, we identified 171 patients who underwent lumbar fusion to revise a previous lumbar spine surgery. All had prospectively collected outcome measures at a minimum 2-year follow-up. The study group included 91 patients who had previous discectomy or laminectomy, 42 patients undergoing revision for adjacent segment degeneration (ASD) and 38 patients undergoing revision for nonunion. All patients completed the Oswestry Disability Index (ODI), MOS Short Form 36 (SF-36), and back and leg pain numerical rating scores before surgery and at 1 and 2 years after surgery. We compared mean changes in outcome measures and percentage of patients reaching the minimum clinically important difference (MCID) threshold in the 3 groups. Logistic regression analysis was performed to identify preoperative factors which could predict significant improvement. Results Statistically significant improvements were noted in back pain, leg pain, and ODI in all 3 groups. Postdecompression and ASD patients demonstrated significant improvements in SF-36 PCS at 2 years, while nonunion patients did not. A total of 49% of postdecompression patients, 38% of ASD patients, and 29% of nonunion patients reached the MCID for ODI. About 46% of postdecompression patients, 40% of ASD patients, and 24% of nonunion patients reached the MCID for SF-36 PCS. Significant improvement from index surgery was the only factor which able to predict reaching the MCID for ODI, while worker's compensation and narcotic use predicted failure to reach the MCID for SF-36 PCS. Conclusion The current study demonstrates that patients undergoing lumbar fusion as a revision of a prior lumbar surgery can expect only modest improvements in health-related quality of life. Postdecompression patients achieved moderate improvements in clinical outcome measures, whereas ASD and nonunion patients showed only modest improvements. Further investigation is needed to identify preoperative predictors that will assist the selection of patients who will benefit from revision lumbar fusion.

Study Design. Case-control propensity matched. Objective. To compare clinical outcomes after lumbar fusion in patients receiving workers' compensation with a case-matched control group who are not on workers' compensation. Summary of Background Data. Previous studies have demonstrated poor outcomes in patients receiving workers' compensation after lumbar fusion. However, a case-control study where patients are matched for covariates known to affect outcomes after lumbar fusion, including baseline clinical outcome measures, has not been done. Methods. From 783 patients who underwent posterolateral fusion with complete preoperative and 2-year postoperative outcome measures, 60 patients who were receiving workers' compensation were identified. Outcome measures included the Oswestry Disability Index (ODI), Short Form-36 (SF-36), and back and leg pain numerical rating scales. Propensity scoring technique was used to match these patients with a control group not receiving workers' compensation using sex, age, smoking status, body mass index, diagnosis, number of levels fused, preoperative ODI, SF-36 Physical Component Summary (PCS), SF-36 Mental Component Summary, and back and leg pain scores, producing 58 matched pairs. Results. There were no significant differences between the demographics, job classification, and preoperative outcome scores in the two groups. At 2 years after operation, patients not receiving workers' compensation had a significantly greater improvement in ODI (P = 0.009) and SF-36 PCS (P = 0.007) compared with those receiving workers' compensation. Although patients not receiving workers' compensation had greater improvements in back and leg pain compared with those receiving workers' compensation, this did not reach statistical significance (P = 0.079). The mean 2-year ODI, SF-36 PCS, and back pain raw scores of patients receiving workers' compensation were significantly lower than those not receiving workers' compensation. Only 19% of workers' compensation patients achieved minimum clinically important difference in terms of ODI compared with 36% of those not receiving workers' compensation (P= 0.061). Only 16% of workers' compensation patients achieved SF-36 PCS minimum clinically important difference compared with 40% of those not receiving workers' compensation (P = 0.006). Conclusion. After controlling for covariates known to affect outcomes after lumbar fusion, patients on workers' compensation have significantly less improvement of clinical outcomes in both mean change in ODI and SF-36 PCS, as well as the number of patients achieving substantial clinical benefit. The improvement in back pain was similar between the two groups, but patients on workers' compensation remained more disabled after lumbar fusion. Differences in outcomes may be related to unidentified covariates associated with workers' compensation status.

STUDY DESIGN: Prospective longitudinal cohort. OBJECTIVE: This study evaluated the effect of preoperative Mental Component Summary (MCS), preoperative Physical Component Summary (PCS), preoperative Oswestry Disability Index (ODI), back pain predominance, body mass index (BMI), age, smoking status, and workers' compensation on health-related quality of life after lumbar fusion. These factors were selected as they are readily available and may influence a surgeon's decision-making process. SUMMARY OF BACKGROUND DATA: Measures of health-related quality of life are increasingly used to evaluate treatment effectiveness. However, their use as a predictive tool to determine which patients will improve has been limited. METHODS: The Short Form 36 (SF-36) and ODI were collected before surgery and two years after surgery in 489 patients undergoing lumbar fusion for degenerative disorders. Linear regression modeling was used to determine the effect of preoperative MCS, preoperative PCS, preoperative ODI, back pain predominance, BMI, age, smoking status, and workers' compensation on the change in ODI and change in SF-36 PCS two years after lumbar fusion. RESULTS: Patients with better preoperative MCS (P = 0.008) and worse preoperative ODI scores (P < 0.0001) achieved greater ODI improvement. Workers' compensation patients did significantly worse (P = 0.03). Patients with better preoperative MCS (P = 0.0004), better preoperative PCS (P = 0.0155), and worse preoperative ODI scores (P = 0.0210) achieved greater PCS improvement. Those on workers' compensation had lower changes in PCS, an effect that was nearly significant (P = 0.0644). There were no significant correlations between PCS and ODI improvement and back pain predominance, BMI, age, and smoking status. Attempts at determining threshold values for MCS, PCS, and ODI that are predictive of a patient achieving minimum clinically important difference for PCS and ODI were unsuccessful. CONCLUSION: Patients with good preoperative MCS and poor preoperative ODI scores who are not on workers' compensation are more likely to improve after lumbar fusion. Threshold values for MCS, PCS, and ODI predictive of a patient achieving minimum clinically important difference for PCS and ODI could not be determined.

Study Design. Prospective randomized controlled trial of rhBMP-2/ACS (Infuse bone graft) versus iliac crest bone graft (ICBG) for lumbar spine fusion in patients over 60 years of age. Objective. To report on clinical, radiographic, and economic outcomes, at 2-year follow-up, in patients treated by posterolateral lumbar fusion with rhBMP-2/ACS versus ICBG. Summary of Background Data. RhBMP-2/ACS is widely used "off-label" for posterolateral spinal fusion. Despite encouraging initial reports, outstanding issues include the need for evidence regarding safety and efficacy in an older population; and an assessment of cost-effectiveness. Methods. Patients over 60 years old were randomized to rhBMP-2/ACS (n = 50) or ICBG (n = 52). Oswestry Disability Index, Short Form-36, and numerical rating scales for back and leg pain were determined preoperatively and at 6, 12, and 24 months postoperatively. Fusion was evaluated by fine-cut computed tomography scan 2 years postoperatively by 3 reviewers. All in-patient and subsequent out-patient event costs were recorded by a dedicated hospital coder. Results. Two-year postoperative improvement in Oswestry Disability Index averaged 15.8 in the rhBMP-2/ACS group and 13.0 in the ICBG group. Mean improvement in Short Form-36 physical component score was 6.6 in the rhBMP-2/ACS group and 7.5 in the ICBG group. There were 20 complications in the ICBG group and 8 complications in the rhBMP-2/ACS group (P = 0.014). Sixteen ICBG and 10 rhBMP-2/ACS patients required additional treatment for persistent back or leg symptoms. Two rh-BMP-2/ACS patients had revision procedures, 1 for nonunion. Eight patients in the ICBG group had revision procedures, 5 for nonunion. Mean fusion grade on computed tomography scan was significantly (P = 0.030) better in the rhBMP-2/ACS (4.3) compared with the ICBG group (3.8). Mean cost of the initial admission was $36,530 in the rhBMP-2/ACS group and $34,235 in the iliac crest bone graft (ICBG) group. Total cost of care over 2 years was $42,574 for the ICBG group and $40,131 for the rhBMP-2/ ACS group. Conclusion. RhBMP-2/ACS is a viable ICBG replacement in older patients in terms of safety, clinical efficacy, and cost-effectiveness.