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

Evaluation of a new navigation system in computer-assisted total knee arthroplasty.

Study Overview

• Status: Active, not recruiting
• Conditions: Gonarthrosis
• Intervention / Treatment: Device: Computer-assisted 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 Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69008
    • Hopital Prive Jean Mermoz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Computer-assisted arthroplasty	Device: Computer-assisted arthroplasty; Computer-assisted arthroplasty
No Intervention: Conventional arthroplasty

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

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 2021-A01677-34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No