J Am Acad Orthop Sur
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J Am Acad Orthop Sur · May 2008
ReviewThe FDA process for the evaluation and approval of orthopaedic devices.
The US Food and Drug Administration (FDA) is a scientific, regulatory, and public health agency whose authority includes overseeing the marketing of products relevant to medical practice. Devices are classified based on the extent of oversight needed to ensure public safety. Divisions within the FDA provide specific expertise regarding drugs, devices, biologic products, and combinations thereof. ⋯ Expert panels advise the agency on issues related to product safety and efficacy, and clinical studies may be required to provide data based on these parameters. Clinical data are monitored postapproval for potential adverse events not evident in earlier trials. Orthopaedic surgeons are involved in all aspects of the FDA as employees, consultants, product advocates, participants in clinical trials and advisory panels, and experts involved in the appropriate reporting of adverse events.
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Ankle fractures in patients with diabetes mellitus have long been recognized as a challenge to practicing clinicians. Complications of impaired wound healing, infection, malunion, delayed union, nonunion, and Charcot arthropathy are prevalent in this patient population. Controversy exists as to whether diabetic ankle fractures are best treated noninvasively or by open reduction and internal fixation. ⋯ Also, Charcot ankle arthropathy occurs more commonly in patients who were initially undiagnosed and had a delay in immobilization and in patients treated nonsurgically for displaced ankle fractures. Several techniques have been described to minimize complications associated with diabetic ankle fractures (eg, rigid external fixation, use of Kirschner wires or Steinmann pins to increase rigidity). Regardless of the specifics of treatment, adherence to the basic principles of preoperative planning, meticulous soft-tissue management, and attention to stable, rigid fixation with prolonged, protected immobilization are paramount in minimizing problems and yielding good functional outcomes.
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During the past three decades, internal fixation has become increasingly popular for fracture management and limb reconstruction. As a result, during their training, orthopaedic surgeons receive less formal instruction in the art of extremity immobilization and cast application and removal. ⋯ Certain materials and methods of ideal cast and splint application are recommended to prevent morbidity in the patient who is at high risk for complications with casting and splinting. Those at high risk include the obtunded or comatose multitrauma patient, the patient under anesthesia, the very young patient, the developmentally delayed patient, and the patient with spasticity.
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De quervain disease, or stenosing tenosynovitis of the first dorsal compartment of the wrist, is a common wrist pathology. Pain results from resisted gliding of the abductor pollicis longus and the extensor pollicis brevis tendons in the fibro-osseus canal. de Quervain tenosynovitis of the wrist is more common in women than men. Diagnosis may be made on physical examination. ⋯ Nonsurgical management, consisting of corticosteroid injections and supportive thumb spica splinting, is usually successful. In resistant cases, surgical release of the first dorsal compartment is done, taking care to protect the radial sensory nerve and identify all accessory compartments. Repair of the extensor retinaculum by step-cut lengthening or other techniques is rarely required.