Hip Revision Surgery Technique for Hip Osteoarthritis

Palo Alto (17 mi)

Overseen byThomas Turgeon, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Orthopaedic Innovation Centre

No Placebo Group

Trial Summary

What is the purpose of this trial?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).

Eligibility Criteria

This trial is for adults needing hip revision surgery due to osteoarthritis, who can follow the study's procedures and self-evaluations. They must be able to use the standard implant without special requirements. Excluded are those with severe obesity (BMI>40), unresolved infections, certain joint diseases, known metal allergies to device components, or participation in another clinical study within 30 days.

Inclusion Criteria

I need a hip revision surgery for either the femoral stem, acetabular cup, or both.

Exclusion Criteria

I need surgery to treat an infection.

I have a condition that causes joint inflammation.

I am able to understand and agree to the study's procedures and risks.

I need a very long press-fit revision stem for surgery.

I currently have an ongoing infection.

I have severe defects, dysplasia, or a tumor.

My BMI is over 40, indicating severe obesity.

Treatment Details

The REDAPT Revision Hip System is being tested for its stability and fixation in patients undergoing hip revision surgery. The focus is on measuring stem subsidence and cup migration over a period of up to five years using model-based RSA imaging techniques.

1Treatment groups

Experimental Treatment

Group I: Hip revisionExperimental Treatment3 Interventions

Revision to cup and stem, cup only or stem only.