Gonarthrosis
Conditions
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).
Interventions
DEVICEComputer-assisted arthroplasty
Computer-assisted arthroplasty
Sponsors
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Single-blind, randomised, prospective comparative study in two parallel groups (conventional or computer-assisted arthroplasty).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| KSS M12 | Month 12 | Assessment of functional outcome at 12 months by Knee Scoring System (KSS) score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety analysis | Month 12 | Descriptive analysis of adverse events |
| KSS M3 | Month 3 | Assessment of functional outcome at 3 months by Knee Scoring System (KSS) score |
| KOOS JR M3 | Month 3 | Functional self-evaluation of the knee joint: Knee injury and Osteoarthritis Outcome Score (KOOS) |
| KOOS JR M12 | Month 12 | Functional self-evaluation of the knee joint: Knee injury and Osteoarthritis Outcome Score (KOOS) |
| EQ-5D M3 | Month 3 | Quality of life evaluation on EuroQol 5D |
| Postoperative outcome predictive factor | Month 1 | Description of a possible correlation between preoperative laxity and postoperative outcome |
| FJS M3 | Month 3 | Self-evaluation of patient satisfaction with Forgotten Joint Score (FJS) |
| FJS M312 | Month 12 | Self-evaluation of patient satisfaction with Forgotten Joint Score (FJS) |
| Surgery duration | Day 0 | Surgery duration |
| Hospitalization duration | Month 1 | Hospitalization duration |
| Lower limb alignment | Month 12 | Measurement of lower limb alignment in degrees of varus or valgus at M3 and M12 |
| EQ-5D M12 | Month 12 | Quality of life evaluation on EuroQol 5D |
Countries
France
Outcome results
None listed