Hip Resurfacing for Arthritis

(BHR Trial)

No longer recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Smith & Nephew, Inc.

Must not be taking: Corticosteroids

Disqualifiers: Infection, Renal insufficiency, Metal sensitivity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Surgical procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Birmingham Hip Resurfacing System for individuals with hip arthritis. The aim is to evaluate the long-term safety and effectiveness of this treatment for non-inflammatory arthritis, like osteoarthritis (where protective cartilage on bone ends wears down), and inflammatory arthritis, such as rheumatoid arthritis (where the immune system attacks the joints). Individuals with hip arthritis considering hip resurfacing surgery might be suitable candidates. Participants must be available for follow-up visits for at least ten years to help researchers assess the treatment's effectiveness. As an unphased trial, this study allows participants to contribute to valuable research that could enhance future arthritis treatments.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Birmingham Hip Resurfacing System is safe for arthritis patients?

Research has shown that the Birmingham Hip Resurfacing (BHR) System is generally safe and well-tolerated by patients. Studies have found that the BHR system lasts a long time, with 95.1% of implants functioning well after 15 years, meaning most patients did not need a replacement during that period.

Another study found similar results, indicating that the BHR system is effective and durable, especially for patients with larger hip sizes. While these results are promising, some patients may have different experiences. Overall, the treatment appears to have a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Birmingham Hip Resurfacing System is unique because, unlike traditional total hip replacements, it preserves more of the patient's natural bone. This system is particularly appealing for younger, active individuals with arthritis who might outlive a conventional hip implant and require a revision surgery later. Researchers are excited about this treatment because it potentially offers better range of motion and stability, allowing patients to maintain a more active lifestyle.

What evidence suggests that the Birmingham Hip Resurfacing System is effective for arthritis?

Research has shown that the Birmingham Hip Resurfacing (BHR) System, which participants in this trial will receive, effectively treats hip arthritis. In the U.S., studies have found that the BHR has a high success rate, with 96% to 99% of patients not needing additional surgery even after 10 years. For men, the BHR system has a 95.1% success rate over 15 years, indicating that most implants function well without issues. Another study reported a similar success rate of about 96.5% after 12 years. These results suggest that the BHR system can provide a long-lasting solution for people with arthritis. ^{2 4 5 6 7}

Who Is on the Research Team?

Edwin Su, MD

Principal Investigator

Hospital for Special Surgery, New York

Christopher Drinkwater, MD

Principal Investigator

University of Rochester

Michael Anderson, MD

Principal Investigator

Aurora Medical Center

John Noble, MD

Principal Investigator

Center for Orthopaedics

Lawrence Housman, MD

Principal Investigator

Tucson Orthopaedic Institute

John Masonis, MD

Principal Investigator

OrthoCarolina Research Institute, Inc.

Andy Engh, MD

Principal Investigator

Anderson Orthopaedic Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 21 with arthritis needing hip resurfacing, who can follow up for ten years. It's not for those with infections, severe muscle or nerve diseases, poor bone quality, metal allergies, women of childbearing age, the immunosuppressed or severely overweight individuals.

Inclusion Criteria

I can attend follow-up visits for the next ten years.

Subject meets none of the exclusion criteria

I am 21 or older and my bones have stopped growing.

Exclusion Criteria

I currently have an infection or sepsis.

Subjects with known or suspected metal sensitivity (e.g. jewelry)

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Birmingham Hip Resurfacing procedure

Surgical procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, including radiographic evaluation and analysis of implant survivorship

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Birmingham Hip Resurfacing System

Trial Overview

The study tests the long-term safety and effectiveness of the Birmingham Hip Resurfacing (BHR) System in patients with various types of arthritis including osteoarthritis and rheumatoid arthritis.

How Is the Trial Designed?

Group I: Hip Resurfacing Experimental Treatment 1 Intervention

Birmingham Hip Resurfacing

Who Is Running the Clinical Trial?

Smith & Nephew, Inc.

Lead Sponsor

Trials

176

Recruited

23,500+

Dr. Maria Berkman

Smith & Nephew, Inc.

Chief Medical Officer since 2023

MD from Harvard Medical School

Dr. Deepak Nath

Smith & Nephew, Inc.

Chief Executive Officer since 2022

PhD in Theoretical Mechanics, University of California, Berkeley

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11905902/

Long-Term Results of the Birmingham Hip Resurfacing ...

The intermediate-term survivorship of the BHR in the U.S. has been shown to be excellent at 10 years, ranging from 96% to 99%. Patient selection ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S0883540325002505

Hip Resurfacing Arthroplasty in Men: A Minimum 15-Year ...

The overall survivorship at 15 years was 95.1%. Implants with femoral head sizes ≥ 48 mm demonstrated 95.8% survivorship, while those < 48 mm showed 91.3% ...

3.

mdpi.com

mdpi.com/1996-1944/17/16/3965

Outcomes of Birmingham Hip Resurfacing Based on ...

The average age was 52, and the follow-up time was 12 years. The overall survival rate was found to be 96.5% (6 revisions). The main revision ...

4.

rheumatologyadvisor.com

rheumatologyadvisor.com/news/birmingham-hip-resurfacing-safe-effective-over-15-years/

Birmingham Hip Resurfacing Safe, Effective Over 15 Years

Birmingham hip resurfacing (BHR) is effective and shows implant longevity in appropriately selected patients, according to a study published in the March 19 ...

5.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf4/p040033b.pdf

Summary of Safety and Effectiveness Data - accessdata.fda.gov

INTRODUCTION: A clinical data series was used to support the safety and effectiveness of the Birmingham Hip. Resurfacing (BHR) system. The BHR was implanted in ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10959564/

Long-Term Outcomes of Birmingham Hip Resurfacing ...

Patients undergoing an HRA with use of the BIRMINGHAM HIP Resurfacing System can expect good implant survivorship at 10 years with acceptable functional ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00611585

A Safety and Efficacy Study of the Birmingham Hip ...

The study will evaluate the long term safety and effectiveness of the BHR system in patients with non-inflammatory and inflammatory arthritis. Detailed ...