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Procedure
Hip Replacement Systems for Hip Osteoarthritis
N/A
Waitlist Available
Led By Thomas Turgeon, MD
Research Sponsored by Canadian Radiostereometric Analysis Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively
Awards & highlights
Study Summary
This trial will assess two hip replacement systems to see how well they work in patients.
Who is the study for?
This trial is for individuals previously enrolled in the DSJ_2018_02 and DSJ_2019_02 studies, without severe diseases like Charcot's or Paget's, not bedridden, with a life expectancy over 2 years, BMI under 45 kg/m2, no recent hip implants or participation in other trials. Pregnant women and those with infections or poor bone quality are excluded.Check my eligibility
What is being tested?
The study continues to evaluate two hip replacement systems: Pinnacle Dual Mobility and Pinnacle Gription Acetabular Cup. It follows up on patients' experiences from previous related trials to assess long-term outcomes of these devices.See study design
What are the potential side effects?
While specific side effects aren't listed for this follow-up study, typical risks of hip replacement may include pain at the surgery site, infection risk around the implant, possible dislocation or loosening of the new joint over time.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~preoperative, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperatively
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in RSA Migrations from baseline(6-week) to 6-month, 1-year and 2-year
Secondary outcome measures
Change of functional outcome over 2 year follow-up period (Harris Hip Score)
Complications
Forgotten Joint Score (FJS)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Pinnacle GriptionExperimental Treatment1 Intervention
Pinnacle Gription Acetabular Cup
Group II: Pinnacle Dual MobilityExperimental Treatment1 Intervention
Pinnacle Dual Mobility System
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Who is running the clinical trial?
Canadian Radiostereometric Analysis NetworkLead Sponsor
7 Previous Clinical Trials
313 Total Patients Enrolled
DePuy SynthesIndustry Sponsor
30 Previous Clinical Trials
4,842 Total Patients Enrolled
Thomas Turgeon, MDPrincipal InvestigatorConcordia Joint Replacement Group
7 Previous Clinical Trials
288 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have Charcot's or Paget's disease.I currently have an infection.I have not had, nor plan to have, hip surgery on the opposite side within 6 months.I have an amputation in my leg that affects my ability to undergo rehabilitation after surgery.I am bedridden as determined by my doctor.My BMI is over 45.I am not pregnant or breastfeeding.I am on medication for a muscle disorder like fibromyalgia that makes it hard to move.My affected limb cannot undergo surgery due to muscle loss or poor blood flow.I need a hip replacement revision and have a specific type of femoral stem.
Research Study Groups:
This trial has the following groups:- Group 1: Pinnacle Gription
- Group 2: Pinnacle Dual Mobility
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.
Is this research endeavor seeking new participants?
"Upon review of the information available on clinicaltrials.gov, it is apparent that this trial has ceased its recruitment endeavours since June 26th 2023. Although there are currently no further opportunities to partake in this study, 96 other medical trials remain open for enrollment at present."
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