Triathlon® Cruciate Retaining (CR) Total Knee System Outcomes Study
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: August 10, 2009
Last updated: November 12, 2015
Last verified: November 2015
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 Design:||Intervention Model: Single Group Assignment
Masking: 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|
Further study details as provided by Stryker Orthopaedics:
Primary Outcome Measures:
- Active Range of Motion [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
- Implant Survivorship [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ]
|Study Start Date:||February 2005|
|Estimated Study Completion Date:||January 2018|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
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.
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.
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00957723
Please refer to this study by its ClinicalTrials.gov identifier: 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|
Sponsors and Collaborators
|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|