NCT04460989 - Assessment of Patient Satisfaction After Arthroplasty: A Comparative Study by Implant Type | Crick

Overview

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.

Prospective randomized monocentric prospective comparative study carried out as a single blind study on two parallel groups (standard implant or customized implant). Secondary Objectives: Compare between groups : * the functional outcome of the arthroplasty * pain progression * the evolution of the quality of life * the conditions of the surgery (duration of surgery, length of hospitalization, blood loss) * the frequency of adverse events related to arthroplasty

Study Type

OBSERVATIONAL

Enrollment

480

Conditions

Gonarthrosis

Interventions

arthroplastyPROCEDURE

total knee replacement

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Neurological diseases, stroke sequelae * Mental disability or any other reason that may hinder the understanding or strict application of the protocol * Patient not affiliated to the French social security scheme * Patient under legal protection, guardianship or trusteeship * Patient already included in another therapeutic study protocol or having participated in another trial within the previous three months * Arthroplasty actually performed * Absence of per operative complications in bone (femoral or tibial bone), ligament (rupture or disinsertion of the patellar or quadricipital tendon) or nerve (lesion of the external popliteal sciatica).

Locations (1)

Centre Orthopédique Santy

Lyon, France

RECRUITING

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.

Time frame: 24 MONTHS

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.

Time frame: 24 months

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

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

Central Contacts

Michel BONNIN, MD

CONTACT

04 37 53 00 26 bonnin.michel@gmail.com

Tarik AIT SI SELMI, MD

CONTACT

04 37 53 07 04 tarik.aitsiselmi@gmail.com