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Completed

NCT Number: NCT00611585

A Safety and Efficacy 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.

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Key information

Conditions

Arthritis Joint Diseases Musculoskeletal Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tucson Orthopaedic Institute, Tucson, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Birmingham Hip Resurfacing

Device

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

Other names: BHR

Primary outcomes

  1. Proportion of Participants with Revision by 10 Years

    Time frame: 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).

Secondary outcomes

  1. Harris Hip Score (HHS): Overall Score

    Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years

    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).

  2. Harris Hip Score (HHS): Pain Score

    Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years

    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).

  3. Harris Hip Score (HHS): Function Score

    Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years

    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).

  4. Harris Hip Score (HHS): Absence of Deformity Score

    Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years

    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).

  5. Harris Hip Score (HHS): Range of Motion Score

    Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years

    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).

  6. Radiographic Assessment: Any Radiographic Findings

    Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years

    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.

  7. Radiographic Assessment: Radiographic Findings for Acetabular Radiolucent Lines

    Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years

    Independent radiographic assessment to determine radiographic findings for presence of any acetabular radiolucent lines (Yes/No).

  8. Radiographic Assessment: Radiographic Findings for Acetabular Migration

    Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years

    Independent radiographic assessment to determine radiographic findings for any acetabular migration (Yes/No).

  9. Radiographic Assessment: Radiographic Findings for Acetabular Osteolysis Lines

    Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years

    Independent radiographic assessment to determine radiographic findings for presence of any acetabular osteolysis lines (Yes/No).

  10. Radiographic Assessment: Radiographic Findings for Acetabular Stress Shielding

    Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years

    Independent radiographic assessment to determine radiographic findings for any acetabular stress shielding (Yes/No).

  11. Radiographic Assessment: Radiographic Findings for Femoral Radiolucent Lines

    Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years

    Independent radiographic assessment to determine radiographic findings for presence of any femoral radiolucent lines (Yes/No).

  12. Radiographic Assessment: Radiographic Findings for Femoral Migration

    Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years

    Independent radiographic assessment to determine radiographic findings for any femoral migration (Yes/No).

  13. Radiographic Assessment: Radiographic Findings for Femoral Osteolysis Lines

    Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years

    Independent radiographic assessment to determine radiographic findings for presence of any femoral osteolysis lines (Yes/No).

  14. Radiographic Assessment: Radiographic Findings for Femoral Stress Shielding

    Time frame: Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years

    Independent radiographic assessment to determine radiographic findings for any femoral stress shielding (Yes/No).

  15. Radiographic Assessment: Heterotopic Ossification

    Time frame: 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years

    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

  16. Cumulative Number of Revisions

    Time frame: 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years

    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).

Sponsors and collaborators

Lead sponsor

Smith & Nephew, Inc.

Industry

Registry information

Official study title

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

Acronym: BHR

Important dates

Study start
2006
Primary completion
2025
Study completion
2025
First posted
Feb 11, 2008
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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