Evaluation of a New Navigation System in Computer-assisted Total Knee Arthroplasty (NaviKnee)

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status

Active, not recruiting

Conditions

Gonarthrosis

Treatments

Device: Computer-assisted arthroplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT05435690

2021-A01677-34

Details and patient eligibility

About

Evaluation of a new navigation system in computer-assisted total knee arthroplasty.

Full 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 arthroplasty), M3 (intermediate visit 3 months after arthroplasty) and M12 (final visit 12 months after arthroplasty).

Enrollment

126 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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