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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00957723
Recruitment Status : Completed
First Posted : August 12, 2009
Results First Posted : April 8, 2014
Last Update Posted : October 12, 2018
Information provided by (Responsible Party):
Stryker Orthopaedics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Knee Device: Triathlon® CR Total Knee System Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 419 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Post-market, Non-randomized, Historical Controlled, Multi-center Study of the Outcomes of the Triathlon® Cruciate Retaining (CR) Total Knee System
Study Start Date : February 2005
Actual Primary Completion Date : April 2010
Actual Study Completion Date : September 26, 2017

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Active Range of Motion [ Time Frame: 2 Years ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Patellar Subluxation, Dislocation and Fracture Rate [ Time Frame: 5 years ]
    The incidence of patellar subluxation, dislocation or fracture is reported.

  8. 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?

  9. Implant Survivorship [ Time Frame: 10 years ]
    Implant survivorship at 10 years postoperative is determined using the Kaplan-Meier method.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00957723

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

Responsible Party: Stryker Orthopaedics Identifier: NCT00957723     History of Changes
Other Study ID Numbers: 56
First Posted: August 12, 2009    Key Record Dates
Results First Posted: April 8, 2014
Last Update Posted: October 12, 2018
Last Verified: October 2018