REDAPT Revision Hip System With RSA

N/AActive Not RecruitingNCT04541693

Orthopaedic Innovation Centre8 enrolled

Overview

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).

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)

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hip Osteoarthritis

Interventions

Full revisionDEVICE

Both cup and stem require revision

Cup revisionDEVICE

Only the cup requires revision

Stem revisionDEVICE

Only the stem requires revision

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Concordia Hospital

Winnipeg, Manitoba, Canada

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 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.

Time frame: 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)

Time frame: 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).

Time frame: Pre-op, Post-op (6 months, 1 year, and 2 years)

Secondary Outcomes

Data from ClinicalTrials.gov

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