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Triathlon PSR Tibial Insert for Joint Replacement Surgery
Study Summary
This trial will study the Triathlon Total Knee System, a new type of knee replacement. They will compare it to the old type of knee replacement to see if it is just as good.
- Joint Replacement Surgery
- Knee
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You are allergic or sensitive to the materials used in the medical device.You have been diagnosed with pain that radiates from your lower back down to your legs.You need a knee replacement surgery and it will be done using cement.Your bones are too weak to support an artificial joint properly.You have severe knee joint instability because the ligaments that hold your knee together are not working properly.You have been diagnosed with avascular necrosis or inflammatory arthritis.You have a mental or neuromuscular condition that could increase the chances of problems with the artificial joint or recovery after surgery.You have a condition called Non-Inflammatory Degenerative Joint Disease (NIDJD).
- Group 1: Triathlon PSR Tibial Insert
- 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
Are there current openings for participants in this trial?
"Affirmative. Clinicaltrials.gov's records show that this research project is actively recruiting volunteers, having been first published on February 8th 2021 and most recently altered on August 26th 2022. 250 participants are needed from one medical centre to participate in the study."
How many people have been recruited to participate in this trial?
"That is correct. According to clinicaltrials.gov, this experimental trial which was first posted on February 8th 2021 is still seeking volunteers. The study requires 250 individuals from one site for enrollment purposes."
Does this research endeavor accept participants who have reached legal adulthood?
"The target population for this medical research is adults aged 18 to 75."
Is it possible to participate in this trial?
"This clinical trial seeks 250 individuals who have undergone arthroplasty, aged between 18 and 75. Additional criteria include: the ability to adhere to post-op evaluations; a signed IRB/EC approved Informed Patient Consent Form; male or non-pregnant female status; skeletally mature; diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD); and eligibility for primary cemented total knee replacement."
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