Clinical Trial

REDAPT Revision Hip System With RSA

Active, Not Recruiting
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Summary
The principal objectives of the study are to evaluate early and mid-term fixation of the REDAPT revision hip stem and acetabular cup as measured by stem subsidence and proximal cup migration at 2 and 5 years post-surgery through model-based RSA. Secondary objectives include; evaluate the progression of migration between 1 and 2 years and between 2 and 5 years, assess pre- to post-surgery patient improvement in function and health status, evaluate femoral and acetabular radiolucency at 2 and 5 years, and assess patterns of stem migrate on for different revision scenarios (preservation of the trochanters and extended trochanteric osteotomy).
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2020-09-04; most recent amendment 2024-11-13.
Status change: Recruiting → Active, Not Recruiting 2023-06-26
Trial Details
NCT Number NCT04541693
Lead Sponsor Orthopaedic Innovation Centre
Conditions Hip Osteoarthritis
Enrollment 8 participants
Start Date 2019-01-15
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-11-15