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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Arthritis
• Intervention / Treatment: Device: Birmingham Hip Resurfacing

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 Type: Interventional
• Enrollment (Actual): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85713
      • Tucson Orthopaedic Institute
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • Center for Orthopaedics
  • New York
    • New York, New York, United States, 10021
      • Hospital For Special Surgery
    • Rochester, New York, United States, 14672
      • University of Rochester Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina
  • Virginia
    • Alexandria, Virginia, United States, 22306
      • Anderson Orthopaedic Clinic
  • Wisconsin
    • Grafton, Wisconsin, United States, 53024
      • Aurora Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Hip Resurfacing; Birmingham Hip Resurfacing	Device: Birmingham Hip Resurfacing; Hip resurfacing system: single use device for hybrid fixation in patients requiring primary hip resurfacing arthroplasty; Other Names: BHR

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events	post op through 10 years

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Principal Investigator: Andy Engh, MD, Anderson Orthopaedic Clinic; Principal Investigator: Lawrence Housman, MD, Tucson Orthopaedic Institute; Principal Investigator: John Masonis, MD, OrthoCarolina Research Institute, Inc.; Principal Investigator: Edwin Su, MD, Hospital for Special Surgery, New York; Principal Investigator: John Noble, Jr., MD, Center for Orthopaedics; Principal Investigator: Michael Anderson, MD, Aurora Medical Center; Principal Investigator: Christopher Drinkwater, MD, University of Rochester

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Anticipated): December 1, 2026
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: January 28, 2008
• First Submitted That Met QC Criteria: February 8, 2008
• First Posted (Estimate): February 11, 2008

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: BHR