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.|
|ClinicalTrials.gov Identifier: NCT00957723|
Recruitment Status : Completed
First Posted : August 12, 2009
Results First Posted : April 8, 2014
Last Update Posted : October 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Arthroplasty, Replacement, Knee||Device: Triathlon® CR Total Knee System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||419 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Active Range of Motion [ Time Frame: 2 Years ]
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Patellar Subluxation, Dislocation and Fracture Rate [ Time Frame: 5 years ]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, 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:
- Do you have any pain in your knee that has the study knee replacement?
- Are you satisfied with the results of your study total knee replacement?
- Have you had any surgery on your study knee since the time of your last study required visit/contact?
- Implant Survivorship [ Time Frame: 10 years ]Implant survivorship at 10 years postoperative is determined using the Kaplan-Meier method.
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 ClinicalTrials.gov 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|
|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|
|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|