The Journal of bone and joint surgery. American volume
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J Bone Joint Surg Am · Mar 2016
Randomized Controlled Trial Multicenter StudyOP-1 Compared with Iliac Crest Autograft in Instrumented Posterolateral Fusion: A Randomized, Multicenter Non-Inferiority Trial.
Spinal fusion with the use of autograft is a commonly performed procedure. However, harvesting of bone from the iliac crest is associated with complications. Bone morphogenetic proteins (BMPs) are extensively used as alternatives, often without sufficient evidence of safety and efficacy. The purpose of this study was to investigate non-inferiority of osteogenic protein-1 (OP-1, also known as BMP-7) in comparison with iliac crest bone graft in posterolateral fusions. ⋯ Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
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J Bone Joint Surg Am · Mar 2016
ReviewAnalysis of FDA-Approved Orthopaedic Devices and Their Recalls.
The U.S. Food and Drug Administration (FDA) evaluates medical devices by two main pathways. The more stringent Premarket Approval (PMA) review requires clinical trials, and the Premarket Notification 510(k) process generally exempts devices from clinical trials if they prove to be substantially equivalent to existing devices. We hypothesized that orthopaedic devices are more likely to be cleared through the 510(k) process and thus are more susceptible to being recalled. ⋯ When orthopaedic surgeons are considering using a new device clinically in their patients, it is important for them to consider how the new device was approved by the FDA. If the device was approved by the 510(k) pathway, then it may have been approved without additional clinical studies confirming efficacy or safety.
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J Bone Joint Surg Am · Mar 2016
Comparative StudyOutcomes of Unicompartmental Knee Arthroplasty After Aseptic Revision to Total Knee Arthroplasty: A Comparative Study of 768 TKAs and 578 UKAs Revised to TKAs from the Norwegian Arthroplasty Register (1994 to 2011).
The general recommendation for a failed primary unicompartmental knee arthroplasty (UKA) is revision to a total knee arthroplasty (TKA). The purpose of the present study was to compare the outcomes, intraoperative data, and mode of failure of primary UKAs and primary TKAs revised to TKAs. ⋯ Despite TKA→TKA seeming to be a technically more difficult surgical procedure, with a higher percentage of re-revisions due to deep infection compared with UKA→TKA, the overall outcomes of UKA→TKA and TKA→TKA were similar.
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J Bone Joint Surg Am · Mar 2016
Dynamic Stabilization with Active Locking Plates Delivers Faster, Stronger, and More Symmetric Fracture-Healing.
Axial dynamization of fractures can promote healing, and overly stiff fixation can suppress healing. A novel technology, termed active plating, provides controlled axial dynamization by the elastic suspension of locking holes within the plate. This prospective, controlled animal study evaluated the effect of active plates on fracture-healing in an established ovine osteotomy model. We hypothesized that symmetric axial dynamization with active plates stimulates circumferential callus and delivers faster and stronger healing relative to standard locking plates. ⋯ The stimulatory effect of controlled motion on fracture-healing by active locking plates has the potential to reduce healing complications and to shorten the time to return to function.
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J Bone Joint Surg Am · Mar 2016
Multicenter Study Comparative Study Clinical TrialComparison of Outcomes of Surgical Treatment for Ossification of the Posterior Longitudinal Ligament Versus Other Forms of Degenerative Cervical Myelopathy: Results from the Prospective, Multicenter AOSpine CSM-International Study of 479 Patients.
Degenerative cervical myelopathy (DCM) is an all-encompassing term that includes cervical spondylotic myelopathy (CSM), ossification of the posterior longitudinal ligament (OPLL), and other spinal abnormalities that cause cervical cord compression. It is unclear whether surgery is equally effective and safe for patients with OPLL as it is for those with other forms of DCM. The purpose of this study was to compare surgical outcomes of patients with OPLL and those with other forms of DCM. ⋯ Surgical decompression for the treatment of OPLL resulted in improvements in functional status and quality of life comparable to those seen in patients with other forms of DCM. Patients with OPLL were at a higher risk of perioperative complications than patients with other forms of DCM.