Stryker Triathlon® Cruciate Substituting vs. Posterior Stabilized Outcomes Study

December 11, 2017 updated by: David F. Scott, MD, Spokane Joint Replacement Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Spokane, Washington, United States, 99218
        • Spokane Joint Replacement Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients undergoing total knee arthroplasty

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cruciate Substituting Tibial Insert
Device: Stryker Triathlon® CS Tibial Insert
Posterior Stabilized Tibial Insert
Device: Stryker Triathlon® PS Tibial Insert

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcomes, Knee Society Score
Time Frame: 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
Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spokane Joint Replacement Center

Investigators

  • Principal Investigator: David F Scott, MD, Spokane Joint Replacement Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

May 22, 2011

First Submitted That Met QC Criteria

June 6, 2011

First Posted (Estimate)

June 7, 2011

Study Record Updates

Last Update Posted (Actual)

December 13, 2017

Last Update Submitted That Met QC Criteria

December 11, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJRC-CS/PS

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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