Triathlon Total Stabilizer (TS) Outcomes Study

October 21, 2021 updated by: Stryker Orthopaedics

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient has signed an Institutional Review Board (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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Triathlon TS Knee
Triathlon TS Knee System
Total knee replacement for revision cases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Society Score (KSS) Change From Preoperative Time Point to 2 Years
Time Frame: pre-op, 2 years

KSS Pain score, KSS Function score, Total Combined KSS

The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (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.

Additionally, the KSS Pain subscore and KSS Function subscore are added together to obtain a total combined score (minimum score 0, maximum score 200).

pre-op, 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Society Score (KSS) Functional Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative
Time Frame: 2 years, 5 years

This outcome measure shows the results of the KSS Functional Score for the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by the amount in mm that the joint line was restored to the physiological joint line postoperative. One group was those that were restored to ≤ 5 mm and the other was those that were restored to > 5mm.

The Functional Score of the Knee Society Clinical Rating System ranges from a potential minimum score of 0 to a maximum score of 100 points. It is based on points assigned to ability to walk, climb stairs and the use of ambulatory aids. A higher value represents a better outcome.

2 years, 5 years
Knee Stability Results Stratified by Joint Line Restoration Groups at 2 and 5 Year Postoperative
Time Frame: 2 year and 5 year postoperative

Measures the knee stability results for the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by amount in mm that the joint line was restored to physiological joint line postoperative. One group were restored to ≤ 5 mm and the other were restored to > 5mm. Knee stability is evaluated in the anterior-posterior (AP) and medial-lateral (ML) planes.

AP drawer test determines instability in mm of the tibia. It was done in the AP plane in both JLR groupings (≤ 5mm and > 5mm) at 2 years and 5 years. The AP measurements were sub categorized into 5mm and 5-10mm.

ML is tested with a varus valgus stress test to determine any instability as measured in degrees. The ML measurements were done in both JLR groupings (≤ 5mm and > 5mm) at 2 years and 5 years with all results in only one category of < 5 degrees.

The higher the number of degrees or mm measured the more instability in the knee.

2 year and 5 year postoperative
Anterior Knee Pain Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative
Time Frame: 2 year and 5 year postoperative

Measures the presence or absence of anterior knee pain in the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by the amount in mm that the joint line was restored to the physiological joint line postoperative. One group was those that were restored to ≤ 5 mm and the other was those that were restored to > 5mm.

Anterior knee pain is determined by clinical examination with patient and clinician whether it is present or absent.

2 year and 5 year postoperative
Short Form Health Survey (SF-36) Health Survey Change From Pre-op to Post-op Visits
Time Frame: pre-op, 1, 2, 5 years
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.
pre-op, 1, 2, 5 years
Number of Knees With Radiographic Stability at 1, 2 and 5 Years Postoperative
Time Frame: 1, 2, 5 years

The scoring system was based on the Knee Society guidelines and determined by measuring the width of the radiolucent lines for each of the zones of the implant components in millimeters.

The total widths are added for each zone which produces a numerical score. Radiolucency in at least 50% of a zone and measuring at least 1 mm in width is defined as radiolucency present. Failure is defined as a score of 10 or greater, regardless of symptoms and considered as radiographic instability.

1, 2, 5 years
Number of Knees With a Revision of Femoral and/or Tibial Baseplate Component
Time Frame: 5 years
Revision was defined as the removal of either the femoral component or the tibial baseplate component.
5 years
Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits
Time Frame: pre-op, 1, 2, 5 years
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.
pre-op, 1, 2, 5 years
Hospital Special Surgery (HSS) Patella Score Change From Pre-op to Post-op Visits
Time Frame: pre-op, 1, 2, 5 years
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.
pre-op, 1, 2, 5 years
Lower Extremity Activity Scale (LEAS) Score Change From Pre-op to Post-op Visits
Time Frame: pre-op, 1, 2, 5 years
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.
pre-op, 1, 2, 5 years
Knee Society Score (KSS) Change From Pre-op to Post-op Visits
Time Frame: pre-op, 1,2, 5 year
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.
pre-op, 1,2, 5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Kirby D Hitt, M.D., Scott & White Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

April 25, 2016

Study Completion (Actual)

March 28, 2019

Study Registration Dates

First Submitted

August 11, 2009

First Submitted That Met QC Criteria

August 12, 2009

First Posted (Estimate)

August 13, 2009

Study Record Updates

Last Update Posted (Actual)

October 22, 2021

Last Update Submitted That Met QC Criteria

October 21, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 65

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arthroplasty, Replacement, Knee

Clinical Trials on Triathlon TS Knee System

3
Subscribe