A Safety and Efficacy Study of the Birmingham Hip Resurfacing System

NCT ID: NCT00611585

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2025-05-12

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.

Conditions

Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hip Resurfacing

Birmingham Hip Resurfacing

Group Type: OTHER

Birmingham Hip Resurfacing

Intervention Type: DEVICE

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

Interventions

Birmingham Hip Resurfacing

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

Intervention Type: DEVICE

Other Intervention Names

BHR

Eligibility Criteria

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

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andy Engh, MD

Role: PRINCIPAL_INVESTIGATOR

Anderson Orthopaedic Clinic

Lawrence Housman, MD

Role: PRINCIPAL_INVESTIGATOR

Tucson Orthopaedic Institute

John Masonis, MD

Role: PRINCIPAL_INVESTIGATOR

OrthoCarolina Research Institute, Inc.

Edwin Su, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

John Noble, Jr., MD

Role: PRINCIPAL_INVESTIGATOR

Center for Orthopaedics

Michael Anderson, MD

Role: PRINCIPAL_INVESTIGATOR

Aurora Medical Center

Christopher Drinkwater, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

Tucson Orthopaedic Institute

Tucson, Arizona, 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

OrthoCarolina

Charlotte, North Carolina, United States

Anderson Orthopaedic Clinic

Alexandria, Virginia, United States

Aurora Medical Center

Grafton, Wisconsin, United States

Countries

United States

Other Identifiers

BHR

Identifier Type: -

Identifier Source: org_study_id