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Triathlon PKR for Knee Replacement Surgery (PKR Trial)
PKR Trial Summary
This trial is comparing the long-term effects of two different types of knee replacements.
PKR Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PKR Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Triathlon PKR
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Who has the opportunity to engage in this experiment?
"This research is looking to enroll 175 individuals aged 21-75 who require a primary cemented unicompartmental knee replacement. In addition, participants must have less than 10 degrees of flexion contracture and greater than 90 degrees of flexion, preoperative mechanical alignment no more than 15 degrees varus or valgus, intact cruciate and collateral ligaments without instability, and they must sign an IRB approved informed consent form."
Are there any open enrollment slots for this clinical experiment?
"Clinicaltrials.gov attests that this medical investigation is actively searching for participants, with the initial posting occurring on January 1st 2010 and a recent update conducted on July 8th 2022."
Does the eligibility for this trial extend to individuals under thirty-five years of age?
"Patients that are 21 to 75 years old may join this clinical trial."
What is the cap on patient enrollment for this clinical trial?
"Affirmative. The clinicaltrials.gov repository contains information that this experiment is currently seeking participants, first posted on January 1st 2010 and last amended July 8th 2022. 175 individuals will be required across 3 sites for the study."
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