Stryker Triathlon® Cruciate Substituting vs. Posterior Stabilized Outcomes Study

Osteoarthritis, Knee Clinical Trial

Official title:

A Prospective, Randomized, Comparison of Total Knee Arthroplasty With the Triathlon® CS Tibial Insert vs. the Triathlon® PS Tibial Insert.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01367925
• Other study ID #: SJRC-CS/PS
• Status: Completed
• Phase: N/A
• First received: May 22, 2011
• Last updated: December 11, 2017
• Start date: December 2007
• Est. completion date: July 2016

Study information

• Verified date: December 2017
• Source: Spokane Joint Replacement Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Stryker Triathlon® CS Tibial Insert

• Stryker Triathlon® PS Tibial Insert

Locations

Country	Name	City	State
United States	Spokane Joint Replacement Center	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Spokane Joint Replacement Center

Country where clinical trial is conducted

United States, 

Outcome

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