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

Not Applicable

Recruiting

• Conditions: Gonarthrosis
• Interventions: Device: Computer-assisted arthroplasty

• Registration Number: NCT05435690
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

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).

Study Timeline

• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2022-06-22
• Study First Posted: 2022-06-28
• Study Start: 2023-01-06
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-05
• Primary Completion: 2027-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computer-assisted arthroplasty	Computer-assisted arthroplasty	-

Primary Outcome Measures

Name	Time	Method
KSS M12	Month 12	Assessment of functional outcome at 12 months by Knee Scoring System (KSS) score

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Privé Jean Mermoz; 🇫🇷 Lyon, France