Triathlon® Cruciate Retaining (CR) Total Knee System Outcomes Study

October 11, 2018 updated by: Stryker Orthopaedics

A Post-market, Non-randomized, Historical Controlled, Multi-center Study of the Outcomes of the Triathlon® Cruciate Retaining (CR) Total Knee System

The purpose of this study is to evaluate the clinical outcomes (range of motion, pain, function, radiographic stability, and health related quality of life) of patients receiving the Triathlon® Cruciate Retaining (CR) Total Knee System. These outcomes will be evaluated by comparing pre-operative to post-operative scores, as well as to a control group. The control group is the Scorpio® CR Total Knee System.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The Triathlon® Cruciate Retaining (CR) Total Knee System components are for use in cemented total knee arthroplasty for painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis (excluded from this study according to protocol). The components are designed to improve range of motion (ROM) and stability. This study serves to demonstrate that subjects have reduced pain, increased ROM and improved stability following implantation with the Triathlon Cruciate Retaining (CR) Total Knee System as compared to the historical control.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
419

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Arizona Institute for Bone and Joint Disorders
    • Florida
      • Miami, Florida, United States, 33136
        • Cedars Medical Center University of Miami
    • Georgia
      • Columbus, Georgia, United States, 31908
        • Hughston Sports Medicine Center
    • Iowa
      • Cedar Rapids, Iowa, United States, 52401
        • Physician's Clinic of Iowa, Mercy Medical Center
    • Massachusetts
      • Newton, Massachusetts, United States, 02462
        • Newton Wellesley Hospital
    • New York
      • Buffalo, New York, United States, 14203
        • Buffalo General Hospital, Department of Orthopaedics Kaleida Health
    • Ohio
      • Akron, Ohio, United States, 44330
        • Crystal Clinic
    • Oregon
      • Bend, Oregon, United States, 97701
        • The Center: Orthopaedic & Neurosurgical Care & Research
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Knoxville Orthopaedic Clinic
    • Texas
      • Temple, Texas, United States, 76508
        • Scott & White Memorial Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233
        • Aurora Advanced Healthcare

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The subject is a male or non-pregnant female between the ages of 21 and 80.
  2. The subject requires a primary cemented total knee replacement.
  3. The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
  4. The subject has intact collateral ligaments.
  5. The subject has signed the IRB-approved, study specific Informed Patient Consent Form.
  6. The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

  1. Patient has inflammatory arthritis.
  2. The subject is morbidly obese, BMI > 40.
  3. The subject has a history of total or unicompartmental reconstruction of the affected joint.
  4. Patient has had a high tibial osteotomy or femoral osteotomy.
  5. The subject has no obvious charcot (i.e. a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device).
  6. The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
  7. The subject is immunologically suppressed, or receiving chronic steroids (> 30 days duration).
  8. The subject's bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prothesis.
  9. The subject has had a knee fusion to the affected joint.
  10. The subject has an active or suspected latent infection in or about the knee joint.
  11. The subject 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Triathlon® CR Total Knee System
Participants receive the Triathlon® CR Total Knee System
Device: Triathlon® CR Total Knee System
The purpose is to evaluate the Triathlon® CR Total Knee System.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Active Range of Motion
Time Frame: 2 Years
2 Years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Knee Society Score (KSS) Over Time
Time Frame: preoperative, 1, 2, and 5 years
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.
preoperative, 1, 2, and 5 years
Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM)
Time Frame: 1, 2, and 5 years
Knee range of motion is measured by the number of degrees flexion and extension observed. Active motion is the number of degrees that a participant can extend and flex their knee independently. Passive motion is the number of degrees that an examiner is able to extend and flex the knee without the assistance of the participant. The Knee Society Score range of motion utilized for this study defines the range from 0 degrees of extension to 125 degrees of flexion.
1, 2, and 5 years
Number of Knees With Radiographic Failure Assessed Via the Knee Society Total Knee Arthroplasty Roentgenographic Score
Time Frame: 1, 2, and 5 years
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 in millimeters 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.
1, 2, and 5 years
Change in SF-36 Health Survey Over Time
Time Frame: preoperative, 1, 2, 3, 4, and 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.
preoperative, 1, 2, 3, 4, and 5 years
Change in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Over Time
Time Frame: preoperative,1, 2, 3, 4 and 5 years
The WOMAC collects information specific to osteoarthritis outcomes. The questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and physical findings. Pain is scored from 0 to 100 for each set of factors, with 0 indicating no pain and 100 indicating extreme pain. Total WOMAC scores range from 0 to 300. Lower values represent better outcomes.
preoperative,1, 2, 3, 4 and 5 years
Change in Lower-Extremity Activity Scale (LEAS) Over Time
Time Frame: preoperative, 1, 2, 3, 4, and 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.
preoperative, 1, 2, 3, 4, and 5 years
Patellar Subluxation, Dislocation and Fracture Rate
Time Frame: 5 years
The incidence of patellar subluxation, dislocation or fracture is reported.
5 years
Patient Outcome Long Term Follow-up Questionnaire Over Time
Time Frame: 6, 7, 8, 9, and 10 years

Patient-reported outcome is collected using a long-term follow-up questionnaire at 6, 7, 8, 9, and 10 years postoperative for the subjects who consent to participation in the long-term follow-up study. The questionnaire consists of three yes or no questions:

  1. Do you have any pain in your knee that has the study knee replacement?
  2. Are you satisfied with the results of your study total knee replacement?
  3. Have you had any surgery on your study knee since the time of your last study required visit/contact?
6, 7, 8, 9, and 10 years
Implant Survivorship
Time Frame: 10 years
Implant survivorship at 10 years postoperative is determined using the Kaplan-Meier method.
10 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stryker Orthopaedics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kirby Hitt, MD, Scott & White Memorial Hospital
  • Principal Investigator: Knute Buehler, MD, The Center: Orthopaedic & Neurosurgical Care & Research
  • Principal Investigator: Brian Covino, MD, Knoxville Orthopedic Clinic
  • Principal Investigator: Joseph Davies, MD, Aurora Advanced Healthcare
  • Study Chair: Kenneth Greene, MD, Crystal Clinic
  • Principal Investigator: Anthony Hedley, MD, Arizona Institute for Bone and Joint Disorders
  • Principal Investigator: Joseph McCarthy, MD, Newton-Wellesley Hospital
  • Principal Investigator: Jeffrey Nassif, MD, Physician's Clinic of Iowa, PC
  • Principal Investigator: Kenneth Krackow, MD, Buffalo General Hospital, Department of Orthopaedics
  • Principal Investigator: Sean Scully, MD, Cedars Medical Center University of Miami
  • Principal Investigator: Mathew Phillips, MD, Buffalo General Hospital, Department of Orthopaedics

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 26, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 56

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.

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