Using MRI To Detect Soft Tissue Reactions And Implant Integration As Related To Implant Modularity (NCT02255331) | Clinical Trial Compass
RecruitingNot Applicable
Using MRI To Detect Soft Tissue Reactions And Implant Integration As Related To Implant Modularity
United States240 participantsStarted 2017-09-15
Plain-language 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 provides a non-invasive biomarker for clinicians and surgeons to detect early adverse synovial reactions which may exist in the absence of clinical symptoms, thus imparting essential information for clinical management. This study will address two of the most commons causes of hip implant failure, including adverse local tissue reaction in implants not traditionally associated with adverse tissue reactions, as well as the presence of aseptic loosening and loss of implant-bone integration.
Who can participate
Age range21 Years – 95 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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)
✓. 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 criteria
✕. Have occupational exposure to cobalt or chromium
✕. Presence of MOM or recalled implant
✕. Have had a prior revision of your total hip
What they're measuring
1
Utilize MRI to evaluate total hip arthroplasty designs traditionally not implicated with the presence of adverse local tissue reactions.
Timeframe: An expected average of 1 year post-operatively
2
Longitudinal monitor of arthroplasty loosening in patients with different individual risk factors and implant bearing surfaces and characteristics
Timeframe: This outcome will be measured at 4 different time points: Initial office visit, 1 year follow-up, 2 year follow-up, 3 year follow-up.