Status:
RECRUITING
Using MRI To Detect Soft Tissue Reactions And Implant Integration As Related To Implant Modularity
Lead Sponsor:
Hospital for Special Surgery, New York
Collaborating Sponsors:
Medical College of Wisconsin
Conditions:
Complications; Arthroplasty
Complications; Arthroplasty, Mechanical
Eligibility:
All Genders
21-95 years
Brief Summary
Patients with a total hip replacement may require early revision surgery due to an adverse local tissue reaction or bone resorption that occurs due to wear debris released from the implant. MRI provid...
Detailed Description
Total hip arthroplasty (THA) has been successful in achieving pain reduction, but recent concerns have been raised regarding the development of adverse local tissue reactions (ALTRs). Our group has pr...
Eligibility Criteria
Inclusion
- Cohort #1:
- Have a total hip replacement with a ceramic component undergoing revision for any reason, including recurrent dislocation.
- Have a metal-on-polyethylene total hip replacement and have repeated dislocation, or
- Have a metal-on-polyethylene total hip replacement greater than 1 year old, or
- Have an infected total hip replacement (any surface bearing)
- Cohort #2:
- Have a total hip replacement with a ceramic component.
- Have a metal-on-polyethylene total hip replacement.
- Have your original or revised total hip replacement.
Exclusion
- Cohort #1:
- Have occupational exposure to cobalt or chromium
- Presence of MOM or recalled implant
- Have had a prior revision of your total hip
- Standard contra-indications to MRI
- Cohort #2:
- Have occupational exposure to cobalt or chromium.
- Have cemented components.
- Presence of a metal-on-metal or recalled implant.
- Standard contra-indications to MRI.
Key Trial Info
Start Date :
September 15 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT02255331
Start Date
September 15 2017
End Date
August 1 2026
Last Update
June 19 2025
Active Locations (1)
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1
Hospital for Special Surgery
New York, New York, United States, 10021