Assessment of Patient Satisfaction After Arthroplasty: A Comparative Study by Implant Type

ConditionGonarthrosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • arthroplasty

    Procedure/Surgery

    total knee replacement

Treatment groups

480 Participants
are divided into 2 treatment groups
Group A: standard implant1 intervention
Group B: personalized implant1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
24 MONTHS

Secondary outcomes

1

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.

Time frame
24 months
2

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.

Time frame
24 months
3

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.

Time frame
24 months

Other outcomes

Sponsors and contacts

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