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: Completed
• 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: Observational
• Enrollment (Actual): 329
• 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

• Sampling Method: Non-Probability Sample

Study Population

The BHR System is a single use device intended for hybrid fixation: cemented femoral head component and cementless acetabular component. The BHR System is intended for use in patients requiring primary hip resurfacing arthroplasty due to:

• Non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/DDH, or
• Inflammatory arthritis such as rheumatoid arthritis. BHR System is intended for patients who, due to relatively younger age or increase activity level, may not be suitable for traditional total hip arthroplasty due to an increase possibility of requiring future ipsilateral hip joint revision.

Description

Inclusion Criteria:

A. Males or females, at least 21 years of age, inclusive, and skeletally mature.

B. The BHR System is a single use device intended for hybrid fixation: cemented femoral head component and cementless acetabular component. The BHR System is intended for use in patients requiring primary hip resurfacing arthroplasty due to:

• non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/DDH, or
• inflammatory arthritis such as rheumatoid arthritis.

The BHR System is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring future ipsilateral hip joint revision.

C. The subject or his/her legal guardian was willing to consent to participate in the study by signing and dating the approved consent form;

D. The subject was available for clinical follow-up through at least ten years postoperative;

E. The patient met none of the exclusion criteria.

Exclusion Criteria:

A. Subjects with infection or sepsis,

B. Subjects with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery,

C. Female subjects of child-bearing age due to unknown effect on the fetus of medal ion release.

D. Subjects with bone stock inadequate to support the device including:

• Subjects with severe osteopenia should not receive a BHR procedure. Patients with a family history of severe osteoporosis or sever osteopenia.
• Subjects with osteonecrosis or avascular necrosis (AVN) with >50% involvement of the femoral head (regardless of FICAT Grade) should not receive a BHR.
• Note: In cases of questionable bone stock, a DEXA scan may be necessary to assess inadequate bone stock.

E. Subjects with known moderate to severe renal insufficiency. Subjects on medications (such as high-dose or chronic aminoglycoside treatment) or with co-morbidities (such as diabetes) that increase the risk of future, significant renal impairment should be advised of the possibility of increase in system medal ion concentration. Preoperative and postoperative monitoring of renal function 9such creatinine, GFR, BUN) at 6wk/3month, 6 month (optional visit), 1-, 2-, 3-, 4,-, 5-, and 10-year time points was necessary.

F. Patients who were immunosuppressed with disease such as AIDS or persons receiving high dose of corticosteroids.

G. Patients with psychological or neurological conditions which would pre-empt their ability or unwillingness to participate in the study.

H. Patients who were severely overweight.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Measure Description	Time Frame
Proportion of Participants with Revision by 10 Years	Proportion of participants with revision by 10 years. A revision was defined as removal with or without replacement of the components (device revision may have been partial or total).	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harris Hip Score (HHS): Overall Score	The Harris Hip Score is a joint specific score that evaluates domains of Pain (1 item, 0-44 points), Function (7 items, 0-47 points), Absence of Deformity (1 item, 0 or 4 points), and hip Range of Motion (2 items, 0-5 points). Total scores range from 0 to 100 with a higher overall score reflecting improved clinical outcomes (i.e., a higher score was a better outcome).	Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Harris Hip Score (HHS): Pain Score	The Harris Hip Score is a joint specific score that evaluates domains of Pain (1 item, 0-44 points), Function (7 items, 0-47 points), Absence of Deformity (1 item, 0 or 4 points), and Range of Motion (2 items, 0-5 points). The Pain domain assesses the severity of hip pain and its interference with daily activities. The score ranges from 0 to 44, with higher scores representing less pain (i.e., a higher score was a better outcome).	Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Harris Hip Score (HHS): Function Score	The Harris Hip Score is a joint specific score that evaluates domains of Pain (1 item, 0-44 points), Function (7 items, 0-47 points), Absence of Deformity (1 item, 0 or 4 points), and Range of Motion (2 items, 0-5 points). The Function domain evaluates the patient's ability to perform daily activities and gait-related tasks. The Function score ranges from 0 to 47, with higher scores indicating better functional performance and mobility (i.e., a higher score was a better outcome).	Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Harris Hip Score (HHS): Absence of Deformity Score	The Harris Hip Score is a joint specific score that evaluates domains of Pain (1 item, 0-44 points), Function (7 items, 0-47 points), Absence of Deformity (1 item, 0 or 4 points), and Range of Motion (2 items, 0-5 points). The Absence of Deformity domain assesses structural hip alignment and deformity. The Absence of Deformity score ranges from 0 to 4, with higher scores indicating fewer hip deformities (i.e., a higher score was a better outcome).	Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Harris Hip Score (HHS): Range of Motion Score	The Harris Hip Score is a joint specific score that evaluates domains of Pain (1 item, 0-44 points), Function (7 items, 0-47 points), Absence of Deformity (1 item, 0 or 4 points), and Range of Motion (2 items, 0-5 points). The Range of Motion domain assesses structural hip alignment and deformity. The Range of Motion score ranges from 0 to 5, with higher scores indicating greater hip mobility and improved joint function (i.e., a higher score was a better outcome).	Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Any Radiographic Findings	Independent radiographic assessment to determine radiographic findings (Yes/No). A 'Yes' response for radiographic findings were due to either radiolucencies, migration, osteolysis, stress shielding, or heterotopic ossification.	Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Radiographic Findings for Acetabular Radiolucent Lines	Independent radiographic assessment to determine radiographic findings for presence of any acetabular radiolucent lines (Yes/No).	Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Radiographic Findings for Acetabular Migration	Independent radiographic assessment to determine radiographic findings for any acetabular migration (Yes/No).	Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Radiographic Findings for Acetabular Osteolysis Lines	Independent radiographic assessment to determine radiographic findings for presence of any acetabular osteolysis lines (Yes/No).	Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Radiographic Findings for Acetabular Stress Shielding	Independent radiographic assessment to determine radiographic findings for any acetabular stress shielding (Yes/No).	Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Radiographic Findings for Femoral Radiolucent Lines	Independent radiographic assessment to determine radiographic findings for presence of any femoral radiolucent lines (Yes/No).	Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Radiographic Findings for Femoral Migration	Independent radiographic assessment to determine radiographic findings for any femoral migration (Yes/No).	Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Radiographic Findings for Femoral Osteolysis Lines	Independent radiographic assessment to determine radiographic findings for presence of any femoral osteolysis lines (Yes/No).	Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Radiographic Findings for Femoral Stress Shielding	Independent radiographic assessment to determine radiographic findings for any femoral stress shielding (Yes/No).	Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Radiographic Assessment: Heterotopic Ossification	Independent radiographic assessment to determine heterotopic ossification was measured using the Brooker Scale grading. Participants with Heterotopic Ossification were classified by one of the following grade categories: I (Islands of bone); II (Bone spurs having at least 1 centimeter); III (Bone spurs reducing the space to less than 1 centimeter); IV (Apparent bony ankylosis of the hip); None	3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years
Cumulative Number of Revisions	Cumulative number of participants with hip revisions. A revision was defined as removal with or without replacement of the components (device revision may have been partial or total).	3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 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 (Actual): October 6, 2006
• Primary Completion (Actual): May 12, 2025
• Study Completion (Actual): May 12, 2025

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Arthritis
• Other Study ID Numbers: BHR.PAS.2006.01

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No