Evaluation of Triathlon - a New Total Knee Prosthesis System - Triathlon vs. Duracon
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|ClinicalTrials.gov Identifier: NCT00436982|
Recruitment Status : Completed
First Posted : February 19, 2007
Results First Posted : December 8, 2015
Last Update Posted : February 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Arthroplasty, Replacement, Knee||Device: Cemented Triathlon total knee system Device: Duracon total knee system||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Evaluation of Triathlon - a New Total Knee Prosthesis System. Prospective, Comparative, Randomised, Roentgen Stereophotogrammetric Analysis (RSA) Series|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||January 4, 2017|
Active Comparator: Cemented Triathlon total knee system
The Triathlon total knee system is the successor of the Duracon total knee system and was observed in a prospective randomised, parallel, double-blind study.
Device: Cemented Triathlon total knee system
Active Comparator: Cemented Duracon total knee system
The Duracon total knee system is the predecessor of the Triathlon total knee system and was observed in a prospective randomised, parallel, double-blind study.
Device: Duracon total knee system
- Roentgen Stereophotogrammetric Analysis (RSA) [ Time Frame: 2 years ]To compare the maximum total point motion (MTPM) of the Triathlon and Duracon tibial components at two years assessed by means of RSA.
- Roentgen Stereophotogrammetric Analysis (RSA) [ Time Frame: 3 months, 1, 5, 7 and 10 years ]To compare the maximum total point motion (MTPM) of the Triathlon and Duracon tibial components by means of RSA.
- Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score) [ Time Frame: [Time Frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 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.
- Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire [ Time Frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years ]
KOOS consists of 5 subscales; Pain, other Symptoms, Activities of Daily Living (ADL), Sport and Recreation Function (Sport/Rec) and knee-related Quality of Life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
[taken from User Guide] http://www.koos.nu/
- Investigation of Clinical Performance and Patient Outcome With EQ-5D Patient Questionnaire [ Time Frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years ]
The EQ-5D is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; the EQ visual analogue scale (EQ VAS) and EQ-5D descriptive system. The EQ VAS collects health state values using a 20 cm visual analogue scale with the endpoints labeled best imaginable health state at the top and worst imaginable health state at the bottom, having numeric values of 100 to 0 respectively. The EQ-5D Time Trade-off (TTO) descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/comfort and anxiety/depression. Each dimension has three levels: no problems, some problems and extreme problems, where an overall score of 1 represents full health.
NOTE: While the protocol includes pre-operative, 3 months, and 1 year, this data was not collected.
- Mean Operative Time [ Time Frame: intra-operative ]Skin to skin operative time
- Duration Hospital Stay [ Time Frame: preoperative to discharge ]
- Blood Loss [ Time Frame: intra-operative ]Blood loss during surgery
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): NCT00436982
|Principal Investigator:||Sören Toksvig-Larsen, ass. prof||Department of ortopaedics, Hässleholm Hospital|