Migration and Survival of All-polyethylene Tibial All Poly Components Compared to the Metal-backed Modular Components of the Triathlon CS Total Knee System. A Single Center RSA Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Arthritis
- Sponsor
- Region Skane
- Enrollment
- 60
- Primary Endpoint
- Migration, measured by means of RSA
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
The primary objective is the assessment of prosthetic migration results after two years of the Triathlon CS Knee System with all-polyethylene tibial components compared to the Triathlon CS 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. The 10 years results will be used to verify the predicted long-term survival results.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Migration, measured by means of RSA
Time Frame: 2 years
Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA)
Secondary Outcomes
- Migration, measured by means of RSA(10 years)
- Investigation of clinical performance and patient outcome with the Knee Society Score (KSS)(pre-operative, 3 months, 1, 2, 5, 7 and 10 years)
- 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)
- 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)
- 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)
- Investigation of patient outcome with radiographic analysis(pre-operative, 3 months, 1, 2, 5, 7 and 10 years)