Triathlon Total Stabilizer (TS) Outcomes Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00958789
First received: August 11, 2009
Last updated: May 20, 2016
Last verified: May 2016

August 11, 2009
May 20, 2016
July 2009
April 2016   (final data collection date for primary outcome measure)
Knee Society Score (KSS) change from preoperative time point to 2 years [ Time Frame: pre-op, 2 years ] [ Designated as safety issue: No ]
Total KSS, KSS Pain score, KSS Function score. The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.
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
  • The effect of joint line restoration on post-op stability, anterior knee pain & functional performance. [ Time Frame: 2 years, 5 years ] [ Designated as safety issue: No ]
  • SF-36 Health Survey change from pre-op to post-op visits [ Time Frame: pre-op, 1, 2, 5 years ] [ Designated as safety issue: No ]
    The SF-36 Health Survey is a 36-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
  • Radiographic stability [ Time Frame: 1, 2, 5 years ] [ Designated as safety issue: Yes ]
    Parameters for radiographic failures will follow the guidelines that have been set by the Knee Society. The scoring system for each of the three components is determined by measuring the width of the radiolucent lines for each of the zones in millimeters for each of the three components. The total widths are added for each zone for each of the three prostheses. The total produces a numerical score for each component. Failure is defined as a score of 10 or greater, regardless of symptoms. A migrating or shifting prosthesis, with or without the disappearance of radiolucent lines, should be considered as a possible or impending failure regardless of the score. Radiolucency in at least 50% of a zone and measuring at least 1 mm in width is defined as radiolucency present. Subsidence is defined as settling of the prosthetic component in bone, and is related to the distance between fixed bony landmarks on the tibia and the prosthesis.
  • Revision rates [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Knee injury and Osteoarthritis Outcome Score (KOOS) change from pre-op to post-op visits [ Time Frame: pre-op, 1, 2, 5 years ] [ Designated as safety issue: No ]
    KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
  • HSS Patella Score change from pre-op to post-op visits [ Time Frame: pre-op, 1, 2, 5 years ] [ Designated as safety issue: No ]
    The HSS Patella Score incorporates both subjective symptoms and objective data specific to the patellofemoral joint. It consists of one score from 0-100 with a score of 100 indicating no pain, no functional limitations, no tenderness or crepitus and normal quadriceps strength.
  • Lower Extremity Activity Scale score change from pre-op to post-op visits [ Time Frame: pre-op, 1, 2, 5 years ] [ Designated as safety issue: No ]
    The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.
  • Knee Society Score (KSS) change from pre-op to post-op visits [ Time Frame: pre-op, 1, 5 year ] [ Designated as safety issue: No ]
    The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.
  • 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. 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.
 
Active, not 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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00958789
65
No
Not Provided
Not Provided
Stryker Orthopaedics
Stryker Orthopaedics
Not Provided
Study Chair: Kirby D Hitt, M.D. Scott & White Hospital
Stryker Orthopaedics
May 2016

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