NCT04541693

REDAPT Revision Hip System With RSA

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Orthopaedic Innovation Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Detailed 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)

Conditions

• Hip Osteoarthritis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-01-15
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2020-09-09
• Last updated: 2024-11-15

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study