A Safety and Efficacy Study of the Birmingham Hip Resurfacing System

NCT00611585 | Completed

• 1 other identifier: BHR.PAS.2006.01
• Study Type: observational
• Target: 329
• Locations: 1 country
• Sites: 7

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.

Conditions

Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Harris Hip Score (HHS): Overall Score

  Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years

• Harris Hip Score (HHS): Pain Score

  Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years

• Harris Hip Score (HHS): Function Score

  Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years

• Harris Hip Score (HHS): Absence of Deformity Score

  Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years

• Harris Hip Score (HHS): Range of Motion Score

  Baseline, 3 months, 1 year, 2 years, 3 years, 4 years, 5 years, 10 years

Study Arms (1)

Hip Resurfacing

Birmingham Hip Resurfacing

Device: Birmingham Hip Resurfacing

Interventions

Birmingham Hip Resurfacing DEVICE

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

Also known as: BHR

Hip Resurfacing

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (7)

Tucson Orthopaedic Institute

Tucson, Arizona, 85713, United States

Location

Center for Orthopaedics

Lake Charles, Louisiana, 70601, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

University of Rochester Medical Center

Rochester, New York, 14672, United States

Location

OrthoCarolina

Charlotte, North Carolina, 28207, United States

Location

Anderson Orthopaedic Clinic

Alexandria, Virginia, 22306, United States

Location

Aurora Medical Center

Grafton, Wisconsin, 53024, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

laboratory collection: whole blood, serum

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2008
• First Posted: February 11, 2008
• Study Start: October 6, 2006
• Primary Completion: May 12, 2025
• Study Completion: May 12, 2025
• Last Updated: April 15, 2026

Record last verified: 2024-12

Locations

US (7)