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Recruiting NCT02255331

Using MRI To Detect Soft Tissue Reactions And Implant Integration As Related To Implant Modularity

Trial Parameters

Condition Complications; Arthroplasty
Sponsor Hospital for Special Surgery, New York
Study Type OBSERVATIONAL
Phase N/A
Enrollment 240
Sex ALL
Min Age 21 Years
Max Age 95 Years
Start Date 2017-09-15
Completion 2026-05

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 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.

Eligibility Criteria

Inclusion Criteria: Cohort #1: 1. Have a total hip replacement with a ceramic component undergoing revision for any reason, including recurrent dislocation. 2. Have a metal-on-polyethylene total hip replacement and have repeated dislocation, or 3. Have a metal-on-polyethylene total hip replacement greater than 1 year old, or 4. Have an infected total hip replacement (any surface bearing) Cohort #2: 1. Have a total hip replacement with a ceramic component. 2. Have a metal-on-polyethylene total hip replacement. 3. Have your original or revised total hip replacement. Exclusion Criteria: Cohort #1: 1. Have occupational exposure to cobalt or chromium 2. Presence of MOM or recalled implant 3. Have had a prior revision of your total hip 4. Standard contra-indications to MRI Cohort #2: 1. Have occupational exposure to cobalt or chromium. 2. Have cemented components. 3. Presence of a metal-on-metal or recalled implant. 4. Standard contra-indications to MRI.

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