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ACTIVE NOT RECRUITING
NCT04541693
NA

REDAPT Revision Hip System With RSA

Sponsor: Orthopaedic Innovation Centre

View on ClinicalTrials.gov

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).

Official title: Early Stability Assessment of the REDAPT Revision Hip System With Radiostereometric Analysis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2019-01-15

Completion Date

2027-12-31

Last Updated

2024-11-15

Healthy Volunteers

Yes

Interventions

DEVICE

Full revision

Both cup and stem require revision

DEVICE

Cup revision

Only the cup requires revision

DEVICE

Stem revision

Only the stem requires revision

Locations (1)

Concordia Hospital

Winnipeg, Manitoba, Canada