Status:
RECRUITING
Assessment of Patient Satisfaction After Arthroplasty: A Comparative Study by Implant Type
Lead Sponsor:
GCS Ramsay Santé pour l'Enseignement et la Recherche
Conditions:
Gonarthrosis
Eligibility:
All Genders
18+ years
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 bet...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 27 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT04460989
Start Date
October 27 2021
End Date
October 31 2025
Last Update
July 1 2024
Active Locations (1)
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1
Centre Orthopédique Santy
Lyon, France, 69008