A Safety and Efficacy Study of the Birmingham Hip Resurfacing System

Not Applicable

Active, not recruiting

• Conditions: Arthritis
• Interventions: Device: Birmingham Hip Resurfacing

• Registration Number: NCT00611585
• Lead Sponsor: Smith & Nephew, Inc.

Brief 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.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2008-01-28
• Study First Submitted QC: 2008-02-08
• Study First Posted: 2008-02-11
• Status Verified: 2024-12
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-15
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• At least 21 years of age and skeletally mature
• Patients requiring primary hip resurfacing due to:
• Non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/DDH
• Inflammatory arthritis such as rheumatoid arthritis
• Subject or his/her legal guardian is willing to consent to participate in the study by signing and dating the approved consent form
• Subject is available for clinical follow-up through at least ten years
• Subject meets none of the exclusion criteria

Exclusion Criteria

• Subjects with infection or sepsis
• Subjects with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery
• Female subjects of child-bearing age
• Subjects with bone stock inadequate to support the device
• Subjects with known moderate to severe renal insufficiency
• Subjects with known or suspected metal sensitivity (e.g. jewelry)
• Subjects who are immunosuppressed with diseases such as AIDS or persons receiving high doses of corticosteroids
• Subjects with psychological or neurological conditions which would pre-empt their ability or unwillingness to participate in the study
• Subjects who are severely overweight

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hip Resurfacing	Birmingham Hip Resurfacing	Birmingham Hip Resurfacing

Primary Outcome Measures

Name	Time	Method
Effectiveness evaluation based on incidence of revision, radiographic review and Harris Hip Score	3 months, 1-10 years

Secondary Outcome Measures

Name	Time	Method
Adverse events	post op through 10 years

Trial Locations

Locations (7)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States

Anderson Orthopaedic Clinic; 🇺🇸 Alexandria, Virginia, United States

OrthoCarolina; 🇺🇸 Charlotte, North Carolina, United States

Aurora Medical Center; 🇺🇸 Grafton, Wisconsin, United States

Tucson Orthopaedic Institute; 🇺🇸 Tucson, Arizona, United States

Center for Orthopaedics; 🇺🇸 Lake Charles, Louisiana, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States