Hip Resurfacing for Arthritis

(BHR Trial)

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

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

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

Subject meets none of the exclusion criteria

Exclusion Criteria

I currently have an infection or sepsis.

I am a woman who can become pregnant.

My bones are too weak to support a medical device.

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