NCT05435690
Active, Not Recruiting
N/A
Evaluation of a New Navigation System in Computer-assisted Total Knee Arthroplasty
GCS Ramsay Santé pour l'Enseignement et la Recherche1 site in 1 country126 target enrollmentJanuary 6, 2023
ConditionsGonarthrosis
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Gonarthrosis
- Sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- KSS M12
- Status
- Active, Not Recruiting
- Last Updated
- 5 months ago
Overview
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 arthroplasty), M3 (intermediate visit 3 months after arthroplasty) and M12 (final visit 12 months after arthroplasty).
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
KSS M12
Time Frame: Month 12
Assessment of functional outcome at 12 months by Knee Scoring System (KSS) score
Secondary Outcomes
- KOOS JR M12(Month 12)
- FJS M3(Month 3)
- Hospitalization duration(Month 1)
- KSS M3(Month 3)
- EQ-5D M3(Month 3)
- EQ-5D M12(Month 12)
- FJS M312(Month 12)
- Surgery duration(Day 0)
- Postoperative outcome predictive factor(Month 1)
- KOOS JR M3(Month 3)
- Lower limb alignment(Month 12)
- Safety analysis(Month 12)
Study Sites (1)
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