REDAPT Revision Hip System With RSA

June 26, 2023 updated by: Orthopaedic Innovation Centre

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2K 3S8
        • Concordia Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Hip revision
Revision to cup and stem, cup only or stem only.
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

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
Time Frame: Post-op: 2-week, 6-month, 1-year, 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
Time Frame: Pre-op, Post-op (6 months, 1 year, and 2 years)
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
Time Frame: Pre-op, Post-op (6 months, 1 year, and 2 years)
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
Time Frame: Pre-op, Post-op (6 months, 1 year, and 2 years)
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
Time Frame: Pre-op, Post-op (6 months, 1 year, and 2 years)
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
Time Frame: 1-year, 2-year
Comparing RSA exams at the specified time points to determine relative movement of the REDAPT hip stem
1-year, 2-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orthopaedic Innovation Centre

Investigators

  • Principal Investigator: Thomas Turgeon, MD, Concordia Joint Replacement Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2019

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

August 31, 2020

First Submitted That Met QC Criteria

September 4, 2020

First Posted (Actual)

September 9, 2020

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 26, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2018-092

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hip Osteoarthritis

Clinical Trials on Full revision

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe