Triathlon Total Stabilizer (TS) Outcomes Study
|ClinicalTrials.gov Identifier: NCT00958789|
Recruitment Status : Active, not recruiting
First Posted : August 13, 2009
Results First Posted : May 19, 2017
Last Update Posted : June 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Arthroplasty, Replacement, Knee||Device: Triathlon TS Knee System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||181 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Total Stabilizer (TS) Total Knee System|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||April 25, 2016|
|Estimated Study Completion Date :||April 2019|
Triathlon TS Knee
Triathlon TS Knee System
Device: Triathlon TS Knee System
Total knee replacement for revision cases
- Knee Society Score (KSS) Change From Preoperative Time Point to 2 Years [ Time Frame: pre-op, 2 years ]
KSS Pain score, KSS Function score, Total Combined KSS
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.
Additionally, the KSS Pain subscore and KSS Function subscore are added together to obtain a total combined score (minimum score 0, maximum score 200).
- The Effect of Joint Line Restoration on Post-op Stability, Anterior Knee Pain & Functional Performance. [ Time Frame: 2 years, 5 years ]
- SF-36 Health Survey Change From Pre-op to Post-op Visits [ Time Frame: pre-op, 1, 2, 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.
- Radiographic Stability [ Time Frame: 1, 2, 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 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. A migrating or shifting prosthesis, with or without the disappearance of radiolucent lines, should be considered as a possible or impending failure regardless of the score. Radiolucency in at least 50% of a zone and measuring at least 1 mm in width is defined as radiolucency present. Subsidence is defined as settling of the prosthetic component in bone, and is related to the distance between fixed bony landmarks on the tibia and the prosthesis.
- Revision Rates [ Time Frame: 5 years ]
- Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits [ Time Frame: pre-op, 1, 2, 5 years ]KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
- HSS Patella Score Change From Pre-op to Post-op Visits [ Time Frame: pre-op, 1, 2, 5 years ]The HSS Patella Score incorporates both subjective symptoms and objective data specific to the patellofemoral joint. It consists of one score from 0-100 with a score of 100 indicating no pain, no functional limitations, no tenderness or crepitus and normal quadriceps strength.
- Lower Extremity Activity Scale Score Change From Pre-op to Post-op Visits [ Time Frame: pre-op, 1, 2, 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.
- Knee Society Score (KSS) Change From Pre-op to Post-op Visits [ Time Frame: pre-op, 1, 5 year ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00958789
|United States, Arizona|
|The CORE Institute|
|Phoenix, Arizona, United States, 85023|
|United States, Florida|
|Heekin Institute for Orthopedic Research|
|Jacksonville, Florida, United States, 32204|
|United States, Illinois|
|Midwest Orthopaedics at Rush|
|Chicago, Illinois, United States, 60612|
|United States, Massachusetts|
|Tufts Medical Center|
|Boston, Massachusetts, United States, 02111|
|United States, New Jersey|
|Egg Harbor Township, New Jersey, United States, 08234|
|Ridgewood, New Jersey, United States, 07450|
|United States, New York|
|Upstate Bone and Joint Center|
|East Syracuse, New York, United States, 13057|
|United States, North Carolina|
|University of North Carolina Orthopedics|
|Chapel Hill, North Carolina, United States, 27599|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27703|
|United States, Ohio|
|Wellington Orthopaedic & Sports Medicine|
|Cincinnati, Ohio, United States, 45255|
|United States, Oklahoma|
|The Orthopaedic Center|
|Tulsa, Oklahoma, United States, 74120|
|United States, Texas|
|Scott & White Clinic|
|Temple, Texas, United States, 76508|
|Study Chair:||Kirby D Hitt, M.D.||Scott & White Hospital|