Clinical orthopaedics and related research
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Clin. Orthop. Relat. Res. · Apr 2016
How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?
The FDA approves novel, high-risk medical devices through the premarket approval (PMA) process based on clinical evidence supporting device safety and effectiveness. Devices subsequently may undergo postmarket modifications that are approved via one of several PMA supplement review tracks, usually without additional supporting clinical data. While orthopaedic devices cleared via the less rigorous 510(k) pathway have been studied previously, devices cleared through the PMA pathway and those receiving postmarket PMA supplements warrant further investigation. ⋯ As the ultimate end-users of these devices, orthopaedic surgeons should be aware that even among high-risk medical devices approved via the FDA's PMA pathway, considerable postmarket device modification occurs. Continued postmarket device monitoring will be essential to limit patient safety risks.
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Clin. Orthop. Relat. Res. · Mar 2016
Randomized Controlled Trial Multicenter StudyA Randomized Trial Among Compression Plus Nonsteroidal Antiinflammatory Drugs, Aspiration, and Aspiration With Steroid Injection for Nonseptic Olecranon Bursitis.
Olecranon bursitis might be a minor problem in the outpatient clinic but relatively be common to occur. However, there are few well-designed studies comparing approaches to treatment. ⋯ Level II, therapeutic study.
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Clin. Orthop. Relat. Res. · Mar 2016
How Does the Level of Sacral Resection for Primary Malignant Bone Tumors Affect Physical and Mental Health, Pain, Mobility, Incontinence, and Sexual Function?
En bloc resection for treatment of sacral tumors is the approach of choice for patients with resectable tumors who are well enough to undergo surgery, and studies describe patient survival, postoperative complications, and recurrence rates associated with this treatment. However, most of these studies do not provide patient-reported functional outcomes other than binary metrics for bowel and bladder function postresection. ⋯ Level III, therapeutic study.