Triathlon Total Stabilizer (TS) Outcomes Study

This study is currently recruiting participants. (see Contacts and Locations)
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
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: 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 August 26, 2014