The spine journal : official journal of the North American Spine Society
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Randomized Controlled Trial Multicenter Study Comparative Study
Results of the prospective, randomized, controlled multicenter Food and Drug Administration investigational device exemption study of the ProDisc-C total disc replacement versus anterior discectomy and fusion for the treatment of 1-level symptomatic cervical disc disease.
Cervical total disc replacement (TDR) is intended to address radicular pain and preserve functional motion between two vertebral bodies in patients with symptomatic cervical disc disease (SCDD). ⋯ The results of this clinical trial demonstrate that ProDisc-C is a safe and effective surgical treatment for patients with disabling cervical radiculopathy because of single-level disease. By all primary and secondary measures evaluated, clinical outcomes after ProDisc-C implantation were either equivalent or superior to those same clinical outcomes after Fusion.
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Randomized Controlled Trial
Choice of plate may affect outcomes for single versus multilevel ACDF: results of a prospective randomized single-blind trial.
Conflicting views exist according to the individual philosophy about various plate designs that can be used in anterior cervical discectomy and fusion (ACDF) to achieve clinical and radiological improvement within shortest time period. No prospective randomized study has ever been conducted to clarify the relationship between clinical outcomes, fusion rates, and the choice of plate (static vs. dynamic design). ⋯ Although clinical improvement is a good predictor of successful ACDF, radiological evidence of fusion alone is not reliable as a parameter of success. The design of plate does not affect the outcomes in single-level fusions but statistics indicate that multiple-level fusions may have better clinical outcome when a dynamic plate design is used.
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Randomized Controlled Trial
Is a videotape to change beliefs and behaviors superior to a standard videotape in acute low back pain? A randomized controlled trial.
Cognitive behavioral therapy has been used successfully in acute low back pain (LBP) treatment, but the use of a cognitive behavioral videotape as an adjunct to treatment has not been studied. ⋯ Compared with a standard instructional videotape, a behavioral videotape did not change beliefs, outcomes, or costs over 1 year. Cost-effective behavioral interventions with high patient retention rates are needed, especially for those at greatest risk of high utilization of resources.
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Randomized Controlled Trial Multicenter Study
The safety and efficacy of OP-1 (rhBMP-7) as a replacement for iliac crest autograft for posterolateral lumbar arthrodesis: minimum 4-year follow-up of a pilot study.
Although autogenous bone is still considered to be the gold standard graft material for promoting spinal fusion, other bone graft substitutes have been developed in an attempt to improve arthrodesis rates and avoid the complications associated with the procurement of autograft. The bone morphogenetic proteins (BMPs) represent a family of osteoinductive growth factors that are known to stimulate the osteoblastic differentiation of stem cells. Osteogenic protein-1 (OP-1) Putty is a commercially available BMP preparation that is already approved for use in humans. Previous clinical studies involving patients with degenerative spondylolisthesis have reported that the efficacy and safety of OP-1 Putty is comparable to that of autograft at both 1- and 2-year follow-up. ⋯ Despite the challenges associated with obtaining a solid uninstrumented fusion in patients with degenerative spondylolisthesis, the rates of radiographic fusion, clinical improvement, and overall success associated with the use of OP-1 Putty were at least comparable to that of the autograft controls for at least 48 months after surgery. These results appear to validate the short-term results previously reported for OP-1 Putty and suggest that this material may potentially represent a viable bone graft substitute for certain fusion applications.
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Randomized Controlled Trial Multicenter Study
Randomized, prospective, and controlled clinical trial of pulsed electromagnetic field stimulation for cervical fusion.
Multilevel fusions, the use of allograft bone, and smoking have been associated with an increased risk of nonunion after anterior cervical discectomy and fusion (ACDF) procedures. Pulsed electromagnetic field (PEMF) stimulation has been shown to increase arthrodesis rates after lumbar spine fusion surgery, but there are minimal data concerning the effect of PEMF stimulation on cervical spine fusion. ⋯ This is the first randomized, controlled trial that analyzes the effects of PEMF stimulation on cervical spine fusion. PEMF stimulation significantly improved the fusion rate at 6 months postoperatively in patients undergoing ACDF with an allograft and an anterior cervical plate, the eligibility criteria being patients who were smokers or had undergone multilevel cervical fusion. At 12 months postoperatively, however, the fusion rate for PEMF patients was not significantly different from that of the control group. There were no differences in the incidence of adverse events in the two groups, indicating that the use of PEMF stimulation is safe in this clinical setting.