Triathlon Total Stabilizer (TS) Outcomes Study

This study is currently recruiting participants.
Verified March 2014 by Stryker Orthopaedics
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00958789
First received: August 11, 2009
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

This study will be a prospective, non-randomized evaluation of the change between preoperative and postoperative outcomes for those receiving the Triathlon® TS Total Knee System for a revision knee operation. When available, the Triathlon® TS Extended Condyle Femur (ECF) may also be included. The mean total Knee Society Score (for pain, motion and function) change is not 10% worse than, or is superior to, the expected change according to published revision total knee replacement data, for cases implanted with the Triathlon® TS Total Knee System as compared from preoperative to 2 years postoperative.


Condition Intervention
Arthroplasty, Replacement, Knee
Device: Triathlon TS Knee System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Total Stabilizer (TS) Total Knee System

Resource links provided by NLM:


Further study details as provided by Stryker Orthopaedics:

Primary Outcome Measures:
  • Knee Society Score (KSS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Joint Line restoration on postop stability, anterior knee pain & functional performance. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Preop & postop outcomes other than the KSS (SF-36, KOOS, HSS Patella Score, Krackow Activity Scale) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Radiographic stability, revision rates and complications [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 181
Study Start Date: July 2009
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Triathlon TS Knee
Triathlon TS Knee System
Device: Triathlon TS Knee System
Total knee replacement for revision cases

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has signed an IRB approved, study specific Informed Patient Consent Form.
  • Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.
  • Patient is a candidate for revision of all femoral and tibial components of a total knee replacement.
  • Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

  • Patient has a Body Mass Index (BMI) > 40.
  • Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
  • Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
  • Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
  • Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
  • Patient has a failed unicondylar knee prosthesis.
  • Patient has a known sensitivity to device materials.
  • Patient is a prisoner.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958789

Contacts
Contact: Michael S Howard 201-831-5807 michael.howard@stryker.com
Contact: Danielle Campbell 201-831-5498 danielle.campbell@stryker.com

Locations
United States, Arizona
SHRI-CORE labs Recruiting
Sun City West, Arizona, United States, 85375-5855
Contact: Bethany Larsen    623-537-5695    bethany.larsen@thecoreinstitute.com   
Principal Investigator: David Jacofsky, MD         
Sub-Investigator: Mark Campbell, MD         
Sub-Investigator: Scott Siverhus, MD         
United States, Florida
Heekin Orthopaedic Institute for Research, Inc. Recruiting
Jacksonville, Florida, United States, 32204
Contact: Gwen Gratto-Cox    904-674-2017    gwen@heekinortho.com   
Principal Investigator: David Heekin, M.D.         
United States, Illinois
Midwest Orthopaedics at Rush Recruiting
Chicago, Illinois, United States, 60612
Contact: Jane Garcia    312-432-2418    jane.garcia@rushortho.com   
Principal Investigator: Craig Della Valle, MD         
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Nicole Kneeland    617-636-5159    nkneeland@tuftsmedicalcenter.org   
Principal Investigator: Eric Smith, MD         
United States, New Jersey
Rothman Institute Recruiting
Egg Harbor Township, New Jersey, United States, 08234
Contact: Anne Marie Madden    609-407-6446    annemarie.madden@rothmaninstitute.com   
Contact: Victoria Younger    609-667-7015      
Principal Investigator: Fabio Orozco, MD         
Sub-Investigator: Alvin Ong, MD         
Ridgewood Orthopedics Recruiting
Ridgewood, New Jersey, United States, 07450
Contact: Stephanie Harbeson    201-445-2830 ext 159    sharbeson@ridgewoodortho.com   
Principal Investigator: Mark Pizzurro, MD         
United States, New York
Upstate Bone and Joint Center Recruiting
East Syracuse, New York, United States, 13057
Contact: Tina Craig, CCRP    315-464-8618    craigt@upstate.edu   
Principal Investigator: Timothy Damron, MD         
Sub-Investigator: Robert Sherman, MD         
United States, North Carolina
University of North Carolina Orthopedics Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Jenny Williams, BSN    919-966-2878    JBradfor@unch.unc.edu   
Principal Investigator: Del Gaizo Dan, MD         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27703
Contact: Loretta Taylor    919-668-9179    loretta.taylor@duke.edu   
Principal Investigator: Samuel Wellman, MD         
United States, Ohio
Wellington Orthopaedic & Sports Medicine Recruiting
Cincinnati, Ohio, United States, 45255
Contact: Yvonne Gantenberg    513-924-3502    yvonne@wellingtonortho.com   
Principal Investigator: Joel Sorger, M.D.         
Sub-Investigator: Suresh Nayak, M.D.         
United States, Oklahoma
The Orthopaedic Center Recruiting
Tulsa, Oklahoma, United States, 74120
Contact: Andrea Pope    918-925-3230    apope@toctulsa.com   
Principal Investigator: Yogesh Mittal, MD         
United States, Texas
Scott & White Clinic Recruiting
Temple, Texas, United States, 76508
Contact: Chris Herrick    254-724-9292    cherrick@swmail.sw.org   
Principal Investigator: Kirby Hitt, MD         
Sponsors and Collaborators
Stryker Orthopaedics
Investigators
Study Chair: Kirby D Hitt, M.D. Scott & White Hospital
  More Information

No publications provided

Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT00958789     History of Changes
Other Study ID Numbers: 65
Study First Received: August 11, 2009
Last Updated: March 10, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 17, 2014