Evaluation of a new navigation system in computer-assisted total knee arthroplasty.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
126
Computer-assisted arthroplasty
Hôpital Privé Jean Mermoz
Lyon, France
KSS M12
Assessment of functional outcome at 12 months by Knee Scoring System (KSS) score
Time frame: Month 12
KSS M3
Assessment of functional outcome at 3 months by Knee Scoring System (KSS) score
Time frame: Month 3
KOOS JR M3
Functional self-evaluation of the knee joint: Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Month 3
KOOS JR M12
Functional self-evaluation of the knee joint: Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Month 12
EQ-5D M3
Quality of life evaluation on EuroQol 5D
Time frame: Month 3
EQ-5D M12
Quality of life evaluation on EuroQol 5D
Time frame: Month 12
FJS M3
Self-evaluation of patient satisfaction with Forgotten Joint Score (FJS)
Time frame: Month 3
FJS M312
Self-evaluation of patient satisfaction with Forgotten Joint Score (FJS)
Time frame: Month 12
Surgery duration
Surgery duration
Time frame: Day 0
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Hospitalization duration
Hospitalization duration
Time frame: Month 1
Lower limb alignment
Measurement of lower limb alignment in degrees of varus or valgus at M3 and M12
Time frame: Month 12
Postoperative outcome predictive factor
Description of a possible correlation between preoperative laxity and postoperative outcome
Time frame: Month 1
Safety analysis
Descriptive analysis of adverse events
Time frame: Month 12