A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon Total Knee System Using the Triathlon PSR Tibial Insert

Stryker Orthopaedics1 site in 1 country37 target enrollmentFebruary 8, 2021

ConditionsArthroplasty Knee

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Arthroplasty
Sponsor: Stryker Orthopaedics
Enrollment: 37
Locations: 1
Primary Endpoint: Mean SF-36 Physical Component Score
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Triathlon Total Knee System using the Triathlon PSR Tibial Insert for primary total knee arthroplasty (TKA) in a consecutive series of patients who meet the eligibility criteria. The SF-36 score of subjects receiving the Triathlon Total Knee with the Triathlon PSR insert is expected to be comparable with that of subjects receiving historical Triathlon PS cemented constructs.

Registry

clinicaltrials.gov

Start Date

February 8, 2021

End Date

January 27, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Stryker Orthopaedics

Responsible Party

Sponsor

Eligibility Criteria

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) \>
•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.

Outcomes

Primary Outcomes

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.