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Joint Replacement
Hip Resurfacing for Arthritis (BHR Trial)
N/A
Waitlist Available
Led By Edwin Su, MD
Research Sponsored by Smith & Nephew, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 21 years of age and skeletally mature
Patients requiring primary hip resurfacing due to non-inflammatory arthritis such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/DDH
Must not have
Subjects with infection or sepsis
Subjects with bone stock inadequate to support the device
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will evaluate the long-term safety and effectiveness of the BHR system in patients with arthritis.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, typical risks may include pain at the surgery site, infection risk from surgery, possible reaction to materials used in BHR system if there's a metal sensitivity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 21 or older and my bones have stopped growing.
Select...
I need hip resurfacing due to arthritis or hip damage not caused by inflammation.
Select...
I need hip surgery due to arthritis like rheumatoid arthritis.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I currently have an infection or sepsis.
Select...
My bones are too weak to support a medical device.
Select...
I have moderate to severe kidney problems.
Select...
I have a weakened immune system due to AIDS or I'm taking high doses of steroids.
Select...
I am severely overweight.
Select...
I do not have severe vascular, muscle, or nerve conditions that could affect surgery recovery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Hip ResurfacingExperimental Treatment1 Intervention
Birmingham Hip Resurfacing
Find a Location
Who is running the clinical trial?
Smith & Nephew, Inc.Lead Sponsor
169 Previous Clinical Trials
22,147 Total Patients Enrolled
16 Trials studying Arthritis
1,672 Patients Enrolled for Arthritis
Edwin Su, MDPrincipal InvestigatorHospital for Special Surgery, New York
1 Previous Clinical Trials
200 Total Patients Enrolled
Christopher Drinkwater, MDPrincipal InvestigatorUniversity of Rochester
Michael Anderson, MDPrincipal InvestigatorAurora Medical Center
John Noble, Jr., MDPrincipal InvestigatorCenter for Orthopaedics
Lawrence Housman, MDPrincipal InvestigatorTucson Orthopaedic Institute
John Masonis, MDPrincipal InvestigatorOrthoCarolina Research Institute, Inc.
2 Previous Clinical Trials
240 Total Patients Enrolled
Andy Engh, MDPrincipal InvestigatorAnderson Orthopaedic Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can attend follow-up visits for the next ten years.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.I have moderate to severe kidney problems.I have a weakened immune system due to AIDS or I'm taking high doses of steroids.I am severely overweight.I am 21 or older and my bones have stopped growing.I do not have severe vascular, muscle, or nerve conditions that could affect surgery recovery.I need hip resurfacing due to arthritis or hip damage not caused by inflammation.I need hip surgery due to arthritis like rheumatoid arthritis.
Research Study Groups:
This trial has the following groups:- Group 1: Hip Resurfacing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.