Outcome of lumbar arthrodesis in patients sixty-five years of age or older.

BACKGROUND: The value of lumbar spine arthrodesis in older patients is not well documented. As most of the literature regarding lumbar arthrodesis in older patients has focused on the prevalence of complications, the purpose of this study was to determine the clinical outcomes for older compared with younger patients undergoing lumbar arthrodesis. METHODS: We studied 224 patients who underwent a single-level posterolateral lumbar arthrodesis with an iliac crest bone graft. Outcome measures included the Oswestry Disability Index, the Medical Outcomes Study Short Form-36 and numeric rating scales for back and leg pain, as well as a radiographic assessment of fusion. Outcome measures were evaluated on the basis of the mean change and the percentage of patients reaching a minimum clinically important difference threshold. For comparison, the patients were divided into two groups: 174 patients who were younger than sixty-five years and fifty patients who were sixty-five years of age or older. RESULTS: Substantial improvements from baseline were noted in all of the clinical and health-related quality-of-life measures at the six-month, one-year, and two-year intervals. The mean improvements in the Oswestry Disability Index score at two years postoperatively were 28.5 points for the older patients and 24.5 points for the younger patients. For Short Form-36 physical component summary scores, the mean improvement from baseline was 14.2 points for the older group and 11.7 points for the younger group at two years. The older patients also demonstrated a similar or greater improvement in the numeric rating scale back and leg pain scores at all time intervals, with a significant difference in leg pain scores at two years postoperatively (10.4 points for the older patients and 6.4 points for the younger patients; p=0.002). Perioperative complications, although an obvious concern, did not appear to adversely affect clinical and health-related quality-of-life outcomes at two years postoperatively. CONCLUSIONS: This study demonstrates a substantial benefit for patients sixty-five years of age or older with degenerative disc disease who are treated with a single-level lumbar decompression and instrumented arthrodesis, and we conclude that lumbar arthrodesis is a viable and reasonable treatment option for appropriately selected patients sixty-five years of age or older.

The efficacy of rhBMP-2 for posterolateral lumbar fusion in smokers.

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.

Clinical outcomes and fusion success at 2 years of single-level instrumented posterolateral fusions with recombinant human bone morphogenetic protein-2/compression resistant matrix versus iliac crest bone graft.

STUDY DESIGN: This is a prospective, randomized study comparing iliac crest bone graft to bone morphogenetic protein (BMP)/compression resistant matrix in instrumented posterolateral fusions for single-level lumbar degenerative disease. A higher recombinant human bone morphogenetic protein (rhBMP)-2 dose and a carrier specific for posterior spine applications were used. OBJECTIVES: As part of a Food and Drug Administration IDE study, clinical outcomes and fusion rates of single-level instrumented posterolateral fusions using iliac crest bone graft or BMP/compression resistant matrix were evaluated. SUMMARY OF BACKGROUND DATA: Although iliac crest graft is the gold standard for lumbar fusion, alternatives to obviate the morbidity of graft harvest have become available. Randomized clinical trials have demonstrated equivalent fusion rates and clinical outcomes with rhBMP-2 and a collagen sponge versus autograft in anterior lumbar fusions. A human pilot study using rhBMP-2 with biphasic calcium phosphate demonstrated similar results for posterolateral fusions. METHODS: Demographic and perioperative data, Short Form 36, Oswestry Low Back Pain Disability Index, and leg and back pain scores were determined before surgery, and 1.5, 3, 6, 12, and 24 months after surgery. Independent neuroradiologists' evaluation of fine-cut computerized tomography scans with reconstructions were obtained at 6, 12, and 24 months. RESULTS: There were 98 subjects, 45 in the iliac crest bone graft group and 53 in the BMP/compression resistant matrix group. There were no significant differences for age, weight, sex, smoking, or previous surgery between the groups. The average operative time (2.9 hours) and blood loss (465 cc) in the iliac crest bone graft group was greater than in the BMP/compression resistant matrix group (2.4 hours and 273 cc). There were no significant differences in any outcome measure at all time intervals. The fusion rate was lower in the iliac crest bone graft group (73%) than in the BMP/compression resistant matrix group (88%) at P = 0.051. CONCLUSION: There was significant improvement of Short Form 36 (physical component score and pain), Oswestry Low Back Pain Disability Index, and leg and back pain scores in both groups over all time intervals. Surgical time and blood loss were significantly less in the BMP/compression resistant matrix group. The fusion rate in the BMP/compression resistant matrix group was significantly higher than the iliac crest bone graft group.