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

Study 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).

Official Title
-----------------
Evaluation of a New Navigation System in Computer-assisted Total Knee Arthroplasty

Conditions
-----------------
Gonarthrosis

Intervention / Treatment
-----------------
* Device: Computer-assisted arthroplasty


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-blind, randomised, prospective comparative study in two parallel groups (conventional or computer-assisted arthroplasty).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computer-assisted arthroplasty<br> | Device: Computer-assisted arthroplasty<br>* Computer-assisted arthroplasty<br>|
| No Intervention: Conventional arthroplasty<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KSS M12 | Assessment of functional outcome at 12 months by Knee Scoring System (KSS) score | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KSS M3 | Assessment of functional outcome at 3 months by Knee Scoring System (KSS) score | Month 3 | 
| KOOS JR M3 | Functional self-evaluation of the knee joint: Knee injury and Osteoarthritis Outcome Score (KOOS) | Month 3 | 
| KOOS JR M12 | Functional self-evaluation of the knee joint: Knee injury and Osteoarthritis Outcome Score (KOOS) | Month 12 | 
| EQ-5D M3 | Quality of life evaluation on EuroQol 5D | Month 3 | 
| EQ-5D M12 | Quality of life evaluation on EuroQol 5D | Month 12 | 
| FJS M3 | Self-evaluation of patient satisfaction with Forgotten Joint Score (FJS) | Month 3 | 
| FJS M312 | Self-evaluation of patient satisfaction with Forgotten Joint Score (FJS) | Month 12 | 
| Surgery duration | Surgery duration | Day 0 | 
| Hospitalization duration | Hospitalization duration | Month 1 | 
| Lower limb alignment | Measurement of lower limb alignment in degrees of varus or valgus at M3 and M12 | Month 12 | 
| Postoperative outcome predictive factor | Description of a possible correlation between preoperative laxity and postoperative outcome | Month 1 | 
| Safety analysis | Descriptive analysis of adverse events | Month 12 |