About this trial
The main objective of this study is to evaluate the benefit of personalized prostheses compared to conventional prostheses on patient satisfaction 24 months after total knee arthroplasty.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult man or woman who has signed consent to participate in the study
Patient with uni- or bilateral primary gonarthrosis
For which an indication for total knee arthroplasty has been established
Disqualifiers
History of knee arthroplasty or osteotomy
History of knee fracture
Inflammatory rheumatic disease or any other progressive concomitant disease that may affect the patient's functional prognosis.
Joint or extra-articular deformities of the lower limb of traumatic origin
Trial population
Patient with uni or bilateral primary gonarthrosis
Trial design
Cohort
Prospective
Treatments tested in this trial
arthroplasty
Procedure/Surgerytotal knee replacement
Treatment groups
Trial outcomes
Primary outcomes
IKS self-questionnaire Score at M24
The score obtained on the IKS self-questionnaire at 24 months will be compared between the two treatment groups by an analysis of covariance, with the basal IKS score as a covariate and the type of prosthesis as a factor.
Secondary outcomes
SF12 score at M24
The comparison between groups will be made on the evolution of scores, in relation to the baseline value, by an analysis of covariance with treatment and time as fixed factors, the subject as a random factor and the baseline value as a covariate. The interaction Time x Treatment will be added to the model. The effects of time and treatment will be tested at each evaluation point.
KOOS Score at M24
The comparison between groups will be made on the evolution of scores, in relation to the baseline value, by an analysis of covariance with treatment and time as fixed factors, the subject as a random factor and the baseline value as a covariate. The interaction Time x Treatment will be added to the model. The effects of time and treatment will be tested at each evaluation point.
Forgotten Joint Score at M24
The comparison between groups will be made on the evolution of scores, in relation to the baseline value, by an analysis of covariance with treatment and time as fixed factors, the subject as a random factor and the baseline value as a covariate. The interaction Time x Treatment will be added to the model. The effects of time and treatment will be tested at each evaluation point.
Sponsors and contacts
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