MedTrace Logo

REDAPT Revision Hip System With RSA

NCT04541693 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-11-15

No results posted yet for this study

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).

Conditions

  • Hip Osteoarthritis

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

Sponsors & Collaborators

  • Orthopaedic Innovation Centre

    lead OTHER

Principal Investigators

  • Thomas Turgeon, MD · Concordia Joint Replacement Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-15
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04541693 on ClinicalTrials.gov