A Safety and Efficacy Study of the Birmingham Hip Resurfacing System

Arthritis Clinical Trial

— BHR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00611585
• Other study ID #: BHR
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2006
• Est. completion date: December 2026

Study information

• Verified date: November 2023
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 360
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis

Intervention

Device:
• Birmingham Hip Resurfacing
Hip resurfacing system: single use device for hybrid fixation in patients requiring primary hip resurfacing arthroplasty

Locations

Country	Name	City	State
United States	Anderson Orthopaedic Clinic	Alexandria	Virginia
United States	OrthoCarolina	Charlotte	North Carolina
United States	Aurora Medical Center	Grafton	Wisconsin
United States	Center for Orthopaedics	Lake Charles	Louisiana
United States	Hospital for Special Surgery	New York	New York
United States	University of Rochester Medical Center	Rochester	New York
United States	Tucson Orthopaedic Institute	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness evaluation based on incidence of revision, radiographic review and Harris Hip Score		3 months, 1-10 years
Secondary	Adverse events		post op through 10 years