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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year, 2-year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I need a hip revision surgery for either the femoral stem, acetabular cup, or both.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-year, 2-year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-year, 2-year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
Stem subsidence
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
5 Previous Clinical Trials
637 Total Patients Enrolled
Thomas Turgeon, MDPrincipal InvestigatorConcordia Joint Replacement Group
7 Previous Clinical Trials
362 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need a type of joint replacement that is not metal on polyethylene.I am 18 years old or older.I need surgery to treat an infection.I need a hip revision surgery for either the femoral stem, acetabular cup, or both.I have a condition that causes joint inflammation.I am able to understand and agree to the study's procedures and risks.I need a very long press-fit revision stem for surgery.You are allergic to the metal used in the medical device.I currently have an ongoing infection.I am in the first stage of a two-part surgery due to an infection.I have severe defects, dysplasia, or a tumor.My BMI is over 40, indicating severe obesity.
Research Study Groups:
This trial has the following groups:- Group 1: Hip revision
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical investigation offer participation to those aged sixty and above?
"Based on the criteria for inclusion, an individual must be between 18 and 80 years old to participate in this medical trial."
Answered by AI
What is the current recruitment rate for this research project?
"Affirmative. A review of clinicaltrials.gov confirms that this experiment is currently enrolling volunteers, having first been posted on 15th January 2019 and most recently modified 16th May 2022. 50 patients are sought to be enrolled at a single medical site."
Answered by AI
What are the criteria necessary to join this experiment?
"Qualified individuals must have hip joint issues and be aged between 18 to 80; this clinical trial is currently recruiting up to 50 patients."
Answered by AI
Is there currently an opportunity to join this experiment?
"Clinicaltrials.gov reports that this medical research is recruiting patients for participation; the trial was published on January 15th 2019 and underwent its most recent update on May 16th 2022."
Answered by AI
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