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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00957723
First received: August 10, 2009
Last updated: November 12, 2015
Last verified: November 2015

August 10, 2009
November 12, 2015
February 2005
April 2010   (final data collection date for primary outcome measure)
  • Active Range of Motion [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
  • Implant Survivorship [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
To compare the active range of motion (ROM) values for subjects receiving the Triathlon CR Total Knee System with those of the a control group. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00957723 on ClinicalTrials.gov Archive Site
  • Change in Knee Society Score (KSS) Over Time [ Time Frame: preoperative, 1, 2, 5 years ] [ 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.
  • Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) [ Time Frame: 1,2,5 years ] [ Designated as safety issue: No ]
    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.
  • Number of Knees With Radiographic Failure Assessed Via the Knee Society Total Knee Arthroplasty Roentgenographic Score [ 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 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.
  • Change in SF-36 Health Survey Over Time [ Time Frame: preoperative, 1,2,3,4,5 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.
  • Change in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Over Time [ Time Frame: preoperative,1,2,3,4 and 5 years ] [ Designated as safety issue: No ]
    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.
  • Change in Lower-Extremity Activity Scale (LEAS) Over Time [ Time Frame: preoperative, 1,2,3,4,5 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.
  • Patellar Subluxation, Dislocation and Fracture Rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    The incidence of patellar subluxation, dislocation or fracture is reported.
  • Patient Outcome Long Term Follow-up Questionnaire Over Time [ Time Frame: 6,7,8,9,10 years ] [ Designated as safety issue: No ]
To compare health related quality of life (QOL), radiographic stability, and complications when compared with subject's pre-operative status as well as with the control group, where available. [ Time Frame: 2 years and 5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Triathlon® Cruciate Retaining (CR) Total Knee System Outcomes Study
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.
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Arthroplasty, Replacement, Knee
Device: Triathlon® CR Total Knee System
The purpose is to evaluate the Triathlon® CR Total Knee System.
Triathlon® CR Total Knee System
Participants receive the Triathlon® CR Total Knee System
Intervention: Device: Triathlon® CR Total 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
419
January 2018
April 2010   (final data collection date for primary outcome measure)

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.
Both
21 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00957723
56
No
Not Provided
Not Provided
Stryker Orthopaedics
Stryker Orthopaedics
Not Provided
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
Stryker Orthopaedics
November 2015

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