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Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_10 | Pages 20 - 20
1 Oct 2020
TEN-YEAR RESULTS OF THE FIRST US FDA-APPROVED HIP RESURFACING DEVICE
Engh CA Ho H Bhal V Housman LR Masonis JL Noble JW Hopper RH Su EP
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Introduction

The BIRMINGHAM HIP◊ Resurfacing is a metal-on-metal (MOM) hip implant system approved by the US FDA in 2006. The approval required a multicenter, prospective, post-approval study (PAS). Our purpose is to report the current minimum 10-year results.

Methods

253 patients (280 hips) had surgery between October 2006 and December 2009 at one of 5 sites. We report revisions, survivorship, EQ-5D, Harris Hip Score (HHS), radiographic findings, and metal levels including cobalt (Co) and chromium (Cr). The mean age at surgery was 51 years, 74% male, BMI 28, osteoarthritis 95%. 243 (87%) of hips have known outcome or 10-year minimum follow-up (fup). Prior to 10 years, 5 patients died, 20 hips were revised, and 37 hips did not complete 10-year fup.

Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 542 - 542
1 Dec 2013
Five-Year Results of a Post-Market Approval Study of the First US FDA-Approved Hip Resurfacing Device: A Difference in Survival Between Male and Female Gender
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.

Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 41 - 41
1 Mar 2013
The Use of a Composite Femoral Component in Primary Tha: A 5-Year Prospective, Randomized Controlled, Clinical, Radiographic and DEXA Comparative Study
Cohen R Skrepnik N Katz J Maltry J Housman LR Slagis S Eberle R
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The purpose of this study was to compare the clinical, radiographic, and DEXA results of Epoch® Femoral Component for primary THA with other non-cemented femoral components. The Epoch and Epoch 14+ (Zimmer, Warsaw, IN) Composite Femoral Components were studied in conjunction with the VerSys® Fiber Metal Taper, Fiber Metal Mid coat and Beaded Fullcoat Femoral Components (Zimmer, Warsaw, IN). All patients were randomized into one of five component groups and followed prospectively. All patients across the five groups were matched with respect to demographics and body mass index (BMI) (Table 1). Diagnoses were evenly distributed across all study groups. There was no significant change in BMD at 5-years when compared to the baseline (6 month) DEXA measurements for all component groups except for the Beaded Fullcoat component subset which had significant decreases in BMD in proximal zones 1, 6 and 7, The Fiber Metal Taper showed similar decreases in BMD in zones 1 and 7, and the Epoch Component had a significant decrease in BMD in zone 7 only. Additionally, our DEXA findings complement and support the subjective radiographic interpretations performed for this study cohort. The results from this prospective, randomized controlled clinical trial showed that the Epoch Composite Femoral Component for primary THA can achieve results equal to standard alloy components of varying design. Based on these early results, the Epoch and Epoch 14+ Femoral Components for primary THA are justified for continuance of further prospective study.