Spine
-
Randomized Controlled Trial Multicenter Study
Results of the prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential fusion for the treatment of 1-level degenerative disc disease.
A prospective, randomized, multicenter, Food and Drug Administration-regulated Investigational Device Exemption clinical trial. ⋯ ProDisc-L has been found to be safe and efficacious. In properly chosen patients, ProDisc-L has been shown to be superior to circumferential fusion by multiple clinical criteria.
-
Randomized Controlled Trial
Erector spinae muscle changes on magnetic resonance imaging following lumbar surgery through a posterior approach.
Prospective randomized study of patients undergoing lumbar arthrodesis. ⋯ Erector spinae muscle alterations mainly occur distal to posterior lumbar surgical procedures.
-
Comment Review
Counterpoint: physician-industry relationships can be ethically established, and conflicts of interest can be ethically managed.
Review of the nature of conflicts of interest in physician-industry relationships, with a focus on the efforts to ethically manage physician-industry relationships. ⋯ Careful consideration of conflicts of interest in physician-industry relationships has provided an opportunity to review our goals as physicians in society, and to continue collaborative advancement of our field for the benefit of our patients.
-
Comparative Study
rhBMP-2 (ACS and CRM formulations) overcomes pseudarthrosis in a New Zealand white rabbit posterolateral fusion model.
The study design consisted of a New Zealand white rabbit model of pseudarthrosis repair. Study groups consisting of no graft, autograft, or recombinant human bone morphogenetic protein-2 (rhBMP-2) with absorbable collagen sponge (ACS) or compression resistant matrix (CRM) were evaluated. ⋯ The 2 rhBMP-2 formulations led to significantly higher fusion rates and histologic bone formation than no graft and autograft controls in this pseudarthrosis repair model.