REDAPT Revision Hip System With RSA

Study Overview
=================
Brief 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: femoral stem revision (n=30 hips) acetabular cup revision (n=22 hips)

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

Conditions
-----------------
Hip Osteoarthritis

Intervention / Treatment
-----------------
* Device: Full revision
* Device: Cup revision
* Device: Stem revision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients needing revision hip arthroplasty in which either the femoral stem or the acetabular cup, or both components, will be revised Ability to use study device (not requiring specialized implants) Patients between the ages of 18+ older Patients willing and able to comply with follow-up requirements and self-evaluations Ability to give informed consent Exclusion Criteria: Acute infection requiring washout, debridement, and liner exchange Unresolved infection Undergoing stage 1 of a 2-stage revision for infection Known metal allergy to device components Active participation in another clinical study (within the past 30 days) Known risk for loss to follow-up (significant geographical distance from treatment centre) BMI>40 (severe obesity) Unable to provide informed consent (cognitive impairment) Patients requiring a bearing couple different than metal on polyethylene Patients requiring extreme distal press-fit revision stems (greater than 240 mm in length) Patients with severe defects, dysplasia, or tumor Inflammatory joint disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hip revision<br>Revision to cup and stem, cup only or stem only. | Device: Full revision<br>* Both cup and stem require revision<br>Device: Cup revision<br>* Only the cup requires revision<br>Device: Stem revision<br>* Only the stem requires revision<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in RSA Migrations from baseline(2-week) to 6-month, 1-year and 2-year | Stability over a period of two year measured by migration with Röntgen Stereometric Analysis | Post-op: 2-week, 6-month, 1-year, 2-year | 
| Changes in Oxford-12 Hip Score from baseline(pre-op) to 6-month, 1-year and 2-year | The Oxford Hip Score (OHS) is a patient self-administered 12-item questionnaire with each question having a Likaert-like response option. Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance. The OHS measures pain and general activities of daily living. | Pre-op, Post-op (6 months, 1 year, and 2 years) | 
| Changes in EQ-5D-5L from baseline(pre-op) to 6-month, 1-year and 2-year | The EuroQol 5D 5L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject. | Pre-op, Post-op (6 months, 1 year, and 2 years) | 
| Change is Pain VAS from baseline(pre-op) to 6-month, 1-year and 2-year | Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in patient reported satisfaction as measured using the visual analogue scale (VAS) from 0 (No pain) - 100 (Worst pain imaginable) | Pre-op, Post-op (6 months, 1 year, and 2 years) | 
| Changes in Patient Satisfaction (Likert scale) from baseline(pre-op) to 6-month, 1-year and 2-year | Patient satisfaction with their hip surgery will be assessed using a 5-point Likert scale: Very Unsatisfied (1), Unsatisfied (2), Neutral (3), Satisfied (4), and Very Satisfied (5). | Pre-op, Post-op (6 months, 1 year, and 2 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stem subsidence | Comparing RSA exams at the specified time points to determine relative movement of the REDAPT hip stem | 1-year, 2-year |