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Clinical Trial 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).


Clinical Trial Description

This is a prospective, single arm, consecutive series study of patients undergoing revision hip arthroplasty. Patients will be grouped based on the revision implants they receive during surgery. Patients who receive a full hip revision (stem and cup), will be counted in both study groups. The two study groups are: 1. femoral stem revision (n=30 hips) 2. acetabular cup revision (n=22 hips) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04541693
Study type Interventional
Source Orthopaedic Innovation Centre
Contact
Status Active, not recruiting
Phase N/A
Start date January 15, 2019
Completion date December 31, 2027

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