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Stryker Triathlon® Cruciate Substituting vs. Posterior Stabilized Outcomes Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01367925
Recruitment Status : Completed
First Posted : June 7, 2011
Last Update Posted : December 13, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Osteoarthritis, Knee Device: Stryker Triathlon® CS Tibial Insert Device: Stryker Triathlon® PS Tibial Insert

Study Design

Study Type : Observational
Actual Enrollment : 125 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Prospective, Randomized, Comparison of Total Knee Arthroplasty With the Triathlon® CS Tibial Insert vs. the Triathlon® PS Tibial Insert.
Study Start Date : December 2007
Primary Completion Date : July 2016
Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adult patients undergoing total knee arthroplasty

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367925

United States, Washington
Spokane Joint Replacement Center
Spokane, Washington, United States, 99218
Sponsors and Collaborators
Spokane Joint Replacement Center
Principal Investigator: David F Scott, MD Spokane Joint Replacement Center
More Information

Responsible Party: David F. Scott, MD, PI, Spokane Joint Replacement Center
ClinicalTrials.gov Identifier: NCT01367925     History of Changes
Other Study ID Numbers: SJRC-CS/PS
First Posted: June 7, 2011    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017

Keywords provided by David F. Scott, MD, Spokane Joint Replacement Center:
Total Knee Replacement

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases