A Safety and Efficacy Study of the Birmingham Hip Resurfacing System (BHR)

Smith & Nephew

Status

Active, not recruiting

Conditions

Arthritis

Treatments

Device: Birmingham Hip Resurfacing

Study type

Interventional

Funder types

Industry

Identifiers

NCT00611585

BHR

Details and patient eligibility

About

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.

Full 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.

Enrollment

360 patients

Sex

All

Ages

21 to 75 years old

Volunteers

No Healthy Volunteers

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