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: August 27, 2015
Last verified: August 2015
  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) 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.


Secondary Outcome Measures:
  • 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.


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

Locations
United States, Arizona
The CORE Institute
Phoenix, Arizona, United States, 85023
United States, Florida
Heekin Institute for Orthopedic Research
Jacksonville, Florida, United States, 32204
United States, Illinois
Midwest Orthopaedics at Rush
Chicago, Illinois, United States, 60612
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, New Jersey
Rothman Institute
Egg Harbor Township, New Jersey, United States, 08234
Ridgewood Orthopedics
Ridgewood, New Jersey, United States, 07450
United States, New York
Upstate Bone and Joint Center
East Syracuse, New York, United States, 13057
United States, North Carolina
University of North Carolina Orthopedics
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center
Durham, North Carolina, United States, 27703
United States, Ohio
Wellington Orthopaedic & Sports Medicine
Cincinnati, Ohio, United States, 45255
United States, Oklahoma
The Orthopaedic Center
Tulsa, Oklahoma, United States, 74120
United States, Texas
Scott & White Clinic
Temple, Texas, United States, 76508
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: August 27, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 03, 2015