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

Recruiting

• Conditions: Gonarthrosis
• Interventions: Procedure: arthroplasty

• Registration Number: NCT04460989
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2020-07-02
• Study First Submitted QC: 2020-07-02
• Study First Posted: 2020-07-08
• Study Start: 2021-10-27
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 480

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
standard implant	arthroplasty	arthroplasty with a standard implant
personalized implant	arthroplasty	arthroplasty with a customized implant

Primary Outcome Measures

Name	Time	Method
IKS self-questionnaire Score at M24	24 MONTHS	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 Outcome Measures

Name	Time	Method
Forgotten Joint Score at M24	24 months	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.
SF12 score at M24	24 months	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	24 months	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.

Trial Locations

Locations (1)

Centre Orthopédique Santy; 🇫🇷 Lyon, France