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

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

Recruiting
18 years and older
All
Phase N/A

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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.

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

Eligibility

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 details
    Gonarthrosis

NCT04460989

GCS Ramsay Santé pour l'Enseignement et la Recherche

16 October 2025

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