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

August 11, 2009
March 10, 2014
July 2009
April 2016   (final data collection date for primary outcome measure)
Knee Society Score (KSS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To evaluate the change in outcomes from the preoperative time point to 2 years postoperative in cases implanted with the Triathlon® TS Total Knee System, with regard to both components of the Knee Society Score. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00958789 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To evaluate the effect of Joint Line restoration on postop stability, anterior knee pain & functional performance. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • To evaluate the change between preop & postop outcomes other than the KSS for the Triathlon® TS group, as well as the change for all outcomes before & after date of availability for the extended condylar design. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To review radiographic stability, revision rates and complications for those implanted with the Triathlon® TS Total Knee System. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Triathlon Total Stabilizer (TS) Outcomes Study
A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Total Stabilizer (TS) Total Knee System

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Arthroplasty, Replacement, Knee
Device: Triathlon TS Knee System
Total knee replacement for revision cases
Triathlon TS Knee
Triathlon TS Knee System
Intervention: Device: Triathlon TS Knee System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
181
April 2019
April 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Michael S Howard 201-831-5807 michael.howard@stryker.com
Contact: Danielle Campbell 201-831-5498 danielle.campbell@stryker.com
United States
 
NCT00958789
65
No
Stryker Orthopaedics
Stryker Orthopaedics
Not Provided
Study Chair: Kirby D Hitt, M.D. Scott & White Hospital
Stryker Orthopaedics
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP