Status:
ACTIVE_NOT_RECRUITING
Evaluation of a New Navigation System in Computer-assisted Total Knee Arthroplasty
Lead Sponsor:
GCS Ramsay Santé pour l'Enseignement et la Recherche
Conditions:
Gonarthrosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Evaluation of a new navigation system in computer-assisted total knee arthroplasty.
Detailed Description
Single-blind, randomised, prospective comparative study in two parallel groups (conventional or computer-assisted arthroplasty). The patient will be evaluated during 3 visits: inclusion D0 (before ar...
Eligibility Criteria
Inclusion
- Adult man or woman who has signed the informed consent for participation in the study,
- Patient with primary uni or bilateral gonarthrosis
- For whom an indication for total knee arthroplasty has been given
Exclusion
- History of fracture, arthroplasty or osteotomy of the knee
- Severe preoperative laxity warranting a constrained prosthesis
- Inflammatory rheumatic disease or any other progressive concomitant condition that may impact on the patient's functional prognosis
- Traumatic articular or extra-articular deformities of the lower limb
- Neurological disease, after-effects of a stroke
- Mental deficiency or any other reason that may hinder the understanding or the strict application of the protocol
- Patient not affiliated to the French social security system
- Patient under legal protection, guardianship or curatorship
- Patient already included in another therapeutic study protocol or having participated in another trial in the previous three months
Key Trial Info
Start Date :
January 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT05435690
Start Date
January 6 2023
End Date
May 31 2026
Last Update
December 3 2025
Active Locations (1)
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1
Hôpital Privé Jean Mermoz
Lyon, France, 69008