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Orthopedic Implant

Hip Revision Surgery Technique for Hip Osteoarthritis

N/A
Waitlist Available
Led By Thomas Turgeon, MD
Research Sponsored by Orthopaedic Innovation Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients needing revision hip arthroplasty in which either the femoral stem or the acetabular cup, or both components, will be revised
Be older than 18 years old
Must not have
Acute infection requiring washout, debridement, and liner exchange
Inflammatory joint disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year, 2-year
Awards & highlights
No Placebo-Only Group

Summary

This trial is evaluating a new hip revision surgery technique to see if it is more effective than current methods.

Who is the study for?
This trial is for adults needing hip revision surgery due to osteoarthritis, who can follow the study's procedures and self-evaluations. They must be able to use the standard implant without special requirements. Excluded are those with severe obesity (BMI>40), unresolved infections, certain joint diseases, known metal allergies to device components, or participation in another clinical study within 30 days.
What is being tested?
The REDAPT Revision Hip System is being tested for its stability and fixation in patients undergoing hip revision surgery. The focus is on measuring stem subsidence and cup migration over a period of up to five years using model-based RSA imaging techniques.
What are the potential side effects?
While specific side effects aren't listed here, typical risks associated with hip revision surgeries may include infection risk at the surgical site, potential dislocation or loosening of new implants, pain or discomfort during recovery, bleeding complications, and possible damage to surrounding tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need a hip revision surgery for either the femoral stem, acetabular cup, or both.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need surgery to treat an infection.
Select...
I have a condition that causes joint inflammation.
Select...
I am able to understand and agree to the study's procedures and risks.
Select...
I need a very long press-fit revision stem for surgery.
Select...
I currently have an ongoing infection.
Select...
I have severe defects, dysplasia, or a tumor.
Select...
My BMI is over 40, indicating severe obesity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-year, 2-year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-year, 2-year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change is Pain VAS from baseline(pre-op) to 6-month, 1-year and 2-year
Changes in EQ-5D-5L from baseline(pre-op) to 6-month, 1-year and 2-year
Changes in Oxford-12 Hip Score from baseline(pre-op) to 6-month, 1-year and 2-year
+2 more
Secondary study objectives
Stem subsidence

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Hip revisionExperimental Treatment3 Interventions
Revision to cup and stem, cup only or stem only.

Find a Location

Who is running the clinical trial?

Orthopaedic Innovation CentreLead Sponsor
6 Previous Clinical Trials
662 Total Patients Enrolled
Thomas Turgeon, MDPrincipal InvestigatorConcordia Joint Replacement Group
8 Previous Clinical Trials
373 Total Patients Enrolled

Media Library

REDAPT Revision Hip System (Orthopedic Implant) Clinical Trial Eligibility Overview. Trial Name: NCT04541693 — N/A
Hip Osteoarthritis Research Study Groups: Hip revision
Hip Osteoarthritis Clinical Trial 2023: REDAPT Revision Hip System Highlights & Side Effects. Trial Name: NCT04541693 — N/A
REDAPT Revision Hip System (Orthopedic Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04541693 — N/A
~3 spots leftby Dec 2027
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