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

Status: Completed
Location: See all (7) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
Tucson Orthopaedic Institute
Tucson
Louisiana
Center for Orthopaedics
Lake Charles
North Carolina
OrthoCarolina
Charlotte
New York
Hospital for Special Surgery
New York
University of Rochester Medical Center
Rochester
Virginia
Anderson Orthopaedic Clinic
Alexandria
Wisconsin
Aurora Medical Center
Grafton
Time Frame
Start Date: 2006-09
Completion Date: 2025-05-12
Participants
Target number of participants: 360
Treatments
Other: Hip Resurfacing
Birmingham Hip Resurfacing
Authors
Richard Steinfeld
Related Therapeutic Areas
Sponsors
Leads: Smith & Nephew, Inc.

This content was sourced from clinicaltrials.gov