Stryker Triathlon® Cruciate Substituting vs. Posterior Stabilized Outcomes Study

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Device: Stryker Triathlon® CS Tibial Insert; Device: Stryker Triathlon® PS Tibial Insert

• Registration Number: NCT01367925
• Lead Sponsor: Spokane Joint Replacement Center

Brief Summary

This study compares the clinical and radiographic outcomes obtained with the use of the Stryker Triathalon® Cruciate Substituting (CS) and Posterior Stabilized (PS) tibial inserts.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2011-05-22
• Study First Submitted QC: 2011-06-06
• Study First Posted: 2011-06-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-11
• Last Update Posted: 2017-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• Adults ages 20-80 years old
• Body mass index <40
• Undergoing primary total knee arthroplasty for osteoarthritis of the knee

Exclusion Criteria

• Inflammatory arthritis
• Revisions

Other criteria may apply

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cruciate Substituting Tibial Insert	Stryker Triathlon® CS Tibial Insert	-
Posterior Stabilized Tibial Insert	Stryker Triathlon® PS Tibial Insert	-

Primary Outcome Measures

Name	Time	Method
Clinical outcomes, Knee Society Score	Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative	Clinical outcomes to include overall success, failure rate, revison rate, clinical scores (Knee Society Score), range of motion, pain, stability, radiographic success

Trial Locations

Locations (1)

Spokane Joint Replacement Center; 🇺🇸 Spokane, Washington, United States