Triathlon CS Knee System with all-polyethylene tibial components
DevicePrimary Total Knee Replacement
Other names: Stryker Orthopaedics
NCT Number: NCT04358575
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.
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Notify Me40 year–75 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Primary Total Knee Replacement
Other names: Stryker Orthopaedics
Primary Total Knee Replacement
Other names: Stryker Orthopaedics
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)
Time frame: 10 years
Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA)
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, 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.
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years
Plain radiographs will be obtained for assessment of fixation of the device.
Region Skane
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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