Stryker Cruciate Substituting/Posterior Stabilized Outcomes Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
David F. Scott, MD, Spokane Joint Replacement Center
ClinicalTrials.gov Identifier:
NCT01367925
First received: May 22, 2011
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

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
Osteoarthritis of the Knee

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Triathlon® Cruciate Substituting Versus Posterior Stabilized Outcomes Study

Resource links provided by NLM:


Further study details as provided by Spokane Joint Replacement Center:

Primary Outcome Measures:
  • Clinical outcomes, Knee Society Score [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Clinical outcomes to include overall success, failure rate, revison rate, clinical scores (Knee Society Score), range of motion, pain, stability, radiographic success


Estimated Enrollment: 126
Study Start Date: December 2007
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
CS
CS Group
PS
PS Group

Detailed Description:

This study compares the clinical and radiographic outcomes obtained with the use of the Stryker Triathalon CS and PS tibial inserts.

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Adult patients undergoing TKA

Criteria

Inclusion Criteria:

  • Adults with DJD of the knee ages 20-80 years old
  • BMI less than 40
  • undergoing primary total knee arthroplasty
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01367925

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

No publications provided

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
Study First Received: May 22, 2011
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Spokane Joint Replacement Center:
Osteoarthritis
Total Knee Replacement

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

ClinicalTrials.gov processed this record on September 14, 2014