- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04618770
Triathlon PSR Outcomes Study
A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon Total Knee System Using the Triathlon PSR Tibial Insert
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jeff Broady
- Phone Number: 201-831-5000
- Email: jeff.broady@stryker.com
Study Contact Backup
- Name: Britta von den Brincken
- Phone Number: 00491638999202
- Email: britta.vondenbrincken@stryker.com
Study Locations
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28207
- OrthoCarolina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient has signed an IRB/EC approved; study specific Informed Patient Consent Form.
- Patient is a male or non-pregnant female, skeletally mature, age 18-75 years at time of study device implantation.
- Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
- Patient is a candidate for primary cemented total knee replacement.
- Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion Criteria:
- Patient has a Body Mass Index (BMI) > 45.
- Patient is already participating in the study for a contralateral total knee replacement.
- Patient has a diagnosis of avascular necrosis or inflammatory arthritis.
- Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
- Patient has any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
- Patient has a compromised bone stock which cannot provide adequate support to the prosthesis.
- Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
- Patient is diagnosed with lumbar radicular pain.
- Patient has severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
- Patient has a known sensitivity to device materials.
- Patient is a prisoner.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Triathlon PSR Tibial Insert
Cases receiving a Triathlon Total Knee with the Triathlon PSR Tibial Insert
|
The Triathlon PSR Tibial Insert is intended to be used as a component in primary TKA and is designed to reduce rotational constraint at deep flexion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean SF-36 Physical Component Score
Time Frame: pre-operative, 6 weeks, 1 year
|
The SF-36 is a 36-item patient completed questionnaire to measure general health and well-being.
It includes physical and mental status component sub scores; each ranging from 0-100.
Low values represent a poor health state and high values represent a good health state.
|
pre-operative, 6 weeks, 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EuroQol-5 Dimension (EQ-5D)
Time Frame: PreOp, 6 week, 1 year
|
The EuroQol-5 Dimension (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; EQ-5D descriptive system and the visual analogue scale (VAS). The EQ-5D descriptive system comprises the following five dimensions: mobility self care, usual activities, pain/comfort and anxiety/depression. Each dimension has 3 levels indicating no problems, some problems or extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health and a high score shows better health. With the EQ VAS the respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status). |
PreOp, 6 week, 1 year
|
Range of Motion
Time Frame: PreOp, 6 weeks, 1 year
|
Range of Motion evaluates how much the knee can be bent and straightened.
The normal range of motion is typically 0 to 135 degrees.
|
PreOp, 6 weeks, 1 year
|
Survivorship of Triathlon PSR Insert
Time Frame: 1 Year
|
All-cause survivorship of the Triathlon PSR Tibial Insert will be evaluated through 10 year.
|
1 Year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 103
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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