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General Orthopaedics

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Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 542 - 542
1 Dec 2013
Su E Housman LR Masonis J Noble JW
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Background

Post-market surveillance is necessary to ensure the safety and efficacy of newly introduced technologies and implants. The Birmingham Hip Resurfacing (Smith and Nephew, Inc., Memphis, TN) was the first hip resurfacing implant approved for use by the US FDA in May 2006. A prospective, multi-center postmarket approval study has been in progress to assess safety and efficacy of this implant.

Methods

Patients meeting inclusion criteria were enrolled at five sites. Clinical evaluation and radiographs were obtained at 3 months and 1 year, and annually thereafter for a total of 10 years. Blood metal ion levels were measured at 1 year and 4 years.