NCT00611585

A Safety and Efficacy Study of the Birmingham Hip Resurfacing System

Birmingham Hip Resurfacing System (BHR) Post Approval Study: A Prospective, Multi-Centered Study of the Birmingham Hip Resurfacing System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 329 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to meet a PMA condition of approval of the BHR System. The study will evaluate the long term safety and effectiveness of the BHR system in patients with non-inflammatory and inflammatory arthritis.

Detailed description

This is a post-approval, prospective, non-randomized, longitudinal, unmasked, multi-center, clinical trial designed to evaluate the longer-term safety and effectiveness of the BHR system. The data collected will permit clinical evaluation for the device performance in improving hip pain, function and range of motion through ten years. The study will permit radiographic evaluation of proper component fixation and alignment maintenance through 10 years post-operative. The incidence of revision is an especially important measure in this study. Data collected will allow analysis of the implant survivorship.

Conditions

• Arthritis

Interventions

Type	Name	Description
DEVICE	Birmingham Hip Resurfacing	Hip resurfacing system: single use device for hybrid fixation in patients requiring primary hip resurfacing arthroplasty

Timeline

• Start date: 2006-10-06
• Primary completion: 2025-05-12
• Completion: 2025-05-12
• First posted: 2008-02-11
• Last updated: 2026-04-15

Locations

7 sites across 1 country: United States