The Journal of bone and joint surgery. American volume
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J Bone Joint Surg Am · Apr 2016
CommentSurgical Procedure to Treat Adult Spinal Deformity: Importance of an Informed Decision-Making Process: Commentary on an article by Peter G. Passias, MD, et al.: "Predictors of Revision Surgical Procedure Excluding Wound Complications in Adult Spinal Deformity and Impact on Patient-Reported Outcomes and Satisfaction. A Two-Year Follow-up".
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J Bone Joint Surg Am · Apr 2016
Longitudinal Change of Medial and Lateral Patellar Stiffness After Reconstruction of the Medial Patellofemoral Ligament for Patients with Recurrent Patellar Dislocation.
Longitudinal changes in patellar stiffness following reconstruction of the medial patellofemoral ligament for recurrent patellar dislocation at full extension are unknown. ⋯ Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
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J Bone Joint Surg Am · Apr 2016
Radial Head Fractures Treated with Modular Metallic Radial Head Replacement: Outcomes at a Mean Follow-up of Eight Years.
Radial head arthroplasty is commonly used to treat acute unreconstructible radial head fractures. The purpose of this study was to report on the clinical and radiographic outcomes at a minimum follow-up of five years after radial head arthroplasty with a modular metallic implant for the treatment of acute radial head fractures. ⋯ Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.
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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.