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Not Applicable
Triathlon PSR Tibial Insert for Joint Replacement Surgery
N/A
Waitlist Available
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 preop, 6 week, 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial evaluates a knee replacement system called the Triathlon Total Knee System with a special part known as the PSR Tibial Insert. It targets patients who are having their first knee replacement surgery. The system works by replacing damaged knee parts with artificial ones to help improve movement and reduce pain. The Triathlon Total Knee System has shown excellent early outcomes and high survival rates in previous studies.
Eligible Conditions
- Joint Replacement Surgery
- Knee
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ preop, 6 week, 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~preop, 6 week, 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean SF-36 Physical Component Score
Secondary study objectives
EuroQol-5 Dimension (EQ-5D)
Range of Motion
Survivorship of Triathlon PSR Insert
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Triathlon PSR Tibial InsertExperimental Treatment1 Intervention
Cases receiving a Triathlon Total Knee with the Triathlon PSR Tibial Insert
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Who is running the clinical trial?
Stryker OrthopaedicsLead Sponsor
78 Previous Clinical Trials
20,398 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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).
Research Study Groups:
This trial has the following groups:- Group 1: Triathlon PSR Tibial Insert
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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