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Joint Replacement
Triathlon PKR for Knee Replacement Surgery (PKR Trial)
N/A
Waitlist Available
Led By Paul Jacob, MD
Research Sponsored by Stryker Orthopaedics
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 10-years
Awards & highlights
PKR Trial Summary
This trial is comparing the long-term effects of two different types of knee replacements.
PKR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Investigation of Clinical Performance and Patient Outcome With the Functional Knee Society Score (KSS).
Secondary outcome measures
10-years Kaplan Meier Survival Analysis
PKR Trial Design
1Treatment groups
Experimental Treatment
Group I: Triathlon PKRExperimental Treatment1 Intervention
All subjects enrolled will receive the Triathlon PKR device.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Triathlon PKR
2013
N/A
~70
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Who is running the clinical trial?
Stryker OrthopaedicsLead Sponsor
78 Previous Clinical Trials
20,322 Total Patients Enrolled
Paul Jacob, MDPrincipal InvestigatorOklahoma Sports Science and Orthopaedics
Soren Toksvig-Larsen, MDPrincipal InvestigatorHassleholm Sygehus Ortopaedkirurgisk afd.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition affecting your brain, muscles, or senses that could make it risky for you to have a medical device implanted or could make it difficult to monitor how well the device is working.You have a condition that causes your bones to become weaker and might affect how well you do in the study, according to the surgeon.Your knee can bend at least 90 degrees and has less than 10 degrees of stiffness.You have inflammatory arthritis or a condition called avascular necrosis (AVN).You have had surgery to completely replace or partially repair the affected joint.You have had surgery to repair a torn ACL in your knee in the past.You have an allergy or sensitivity to the materials used in the medical device.Your bones are weakened or infected, and they cannot support the artificial joint properly.You have recently had surgery on your upper leg or knee bones.You have had a previous implant that cannot support or hold the new device securely in place.You need a certain type of knee replacement surgery called primary cemented unicompartmental knee replacement.You have been diagnosed with either osteoarthritis or arthritis caused by a previous injury.Your knee ligaments are healthy and stable.Your leg alignment before surgery is not more than 15 degrees bent inward or outward.
Research Study Groups:
This trial has the following groups:- Group 1: Triathlon PKR
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.
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