The use of rhBMP-2 in interbody fusion cages. Definitive evidence of osteoinduction in humans: a preliminary report.

STUDY DESIGN: A prospective randomized controlled human clinical pilot trial. OBJECTIVES: To determine the feasibility of using rhBMP-2/collagen as a substitute for autogenous bone graft inside interbody fusion cages to achieve arthrodesis in humans. SUMMARY OF BACKGROUND DATA: Preclinical studies have shown rhBMP-2 to be an effective substitute for autogenous bone graft, but there are no studies to date documenting such efficacy for human spine fusion. METHODS: Fourteen patients with single-level lumbar degenerative disc disease refractory to nonoperative management were randomized to receive lumbar interbody arthrodesis with a tapered cylindrical threaded fusion cage filled with rhBMP-2/collagen sponge or autogenous iliac crest bone. Patients were evaluated with radiographs, sagittally reformatted computed tomography scans, and Short Form-36 and Oswestry outcome questionnaires. RESULTS: All 11 patients who received rhBMP-2 were judged by three independent radiologists to have solid fusions (at 6, 12, and 24 months postimplantation), whereas only 2 of the 3 control patients, who received the standard treatment of autogenous iliac crest bone, were deemed to be fused. The Oswestry Disability Questionnaire scores of the rhBMP-2 group improved sooner (after 3 months) than those of the autograft group, with both groups demonstrating similar improvement at 6 months. Short Form 36 scores continued to improve up to 24 months. CONCLUSION: The arthrodesis was found to occur more reliably in patients treated with rhBMP-2-filled fusion cages than in controls treated with autogenous bone graft, although the sample size was limited. There were no adverse events related to the rhBMP-2 treatment. This study is one of the first to show consistent and unequivocal osteoinduction by a recombinant growth factor in-humans.

Transpedicle instrumentation in the degenerative spine.

Controversy continues regarding the use of pedicle instrumentation in fusion surgery on the degenerative lumbar spine. Recently, however, published reports are increasingly demonstrative of the positive effect of pedicle fixation on fusion and outcome success in the management of these disorders. Recent developments in surgical technique and implant design have improved operative risk and implant related complications. However, patient selection and demonstration of the underlying pathophysiology of degenerative lumbar motion segment pain remain 2 of the main challenges to clinical practice. The importance of well designed clinical studies are of paramount consequence in the solution of the existing controversies surrounding surgical treatment of the degenerative lumbar spine. Equally significant is the need to establish general and accepted measures of outcome to assess and compare treatment options. Combining study design and accepted outcome assessment will permit the resolution of the remaining controversies. The future of pedicle instrumentation of the degenerative lumbar spine is of necessity tied to the resolution of these remaining points of controversy-only thereafter can the current rate of advances continue.

Recent medical-legal proceedings and their effect on the practice of medicine in Chicago.

Since January 1994, northern Illinois has experienced a significant increase in litigation, which has been directly related to the lack of FDA approval of pedicle screw devices, and the adverse media attention to the FDA's actions. These activities coupled with those of the Public Citizen Health Research Group's have had a chilling effect on the practice of medicine. This is unwarranted, Congress has never provided the FDA with the authority to regulate the practice of medicine; and the FDA has reiterated that it lacks the intent or ability for such regulation. Medical science continues to outpace the regulatory process, and therefore it will remain the science of medicine that determines the standard of care.