All-poly Versus Metal-backed
- Conditions
- Osteoarthritis
- Interventions
- Device: Triathlon PS Knee System with all-polyethylene tibial componentsDevice: Triathlon PS Knee System with metal-backed modular components
- Registration Number
- NCT04358601
- Lead Sponsor
- Region Skane
- Brief Summary
The primary objective is the assessment of prosthetic migration results after two years of the Triathlon PS Knee System with all-polyethylene tibial components compared to the Triathlon PS Knee System with metal-backed modular components by means of Roentgen Stereophotogrammetry.
- Detailed Description
The secondary objective will be the prediction of the long-term survival based on the two-year migration patterns combined with clinical factors and radiographic aspects. In order to identify other clinical parameters besides the fixation of the prosthesis components, clinical scores and radiographic aspects will be correlated with the RSA outcome.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description All-polyethylene tibial components Triathlon PS Knee System with all-polyethylene tibial components Triathlon PS Knee System with all-polyethylene tibial components Metal-backed modular components Triathlon PS Knee System with metal-backed modular components Triathlon PS Knee System with metal-backed modular components
- Primary Outcome Measures
Name Time Method Migration, measured by means of RSA 2 years Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA)
- Secondary Outcome Measures
Name Time Method Investigation of clinical performance and patient outcome with the Knee Injury and Osteoarthritis Outcome Score (KOOS) patient questionnaire pre-operative, 3 months, 1, 2, 5, 7 and 10 years KOOS consists of 5 subscales: Pain, other symptoms, function in daily living , function in sport and recreation 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).
Migration, measured by means of RSA 10 years Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA)
Investigation of clinical performance and patient outcome with the Knee Society Score (KSS) 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, range of motion (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 the Forgotten Joint Score (FJS) patient questionnaire. pre-operative, 3 months, 1, 2, 5, 7 and 10 years The FJS consists of 12 questions and focuses on the patients' awareness of their joint replacement during a range of day to day and recreational activities. The score has a range of 0-100.questionnaire
Investigation of clinical performance and patient outcome with EuroQuol-5 dimension (EQ-5D) patient questionnaire pre-operative, 3 months, 1, 2, 5, 7 and 10 years The EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status.
Investigation of patient outcome with radiographic analysis pre-operative, 3 months, 1, 2, 5, 7 and 10 years Plain radiographs will be obtained for assessment of fixation of the device.