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

Gonarthrosis Clinical Trial

— NaviKnee  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05435690
• Other study ID #: 2021-A01677-34
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: December 2021
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Jean LANGLOIS, MD
• Phone: 0603294533
• Email: jeangast[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 126
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gonarthrosis
• Osteoarthritis, Knee

Intervention

Device:
• Computer-assisted arthroplasty
Computer-assisted arthroplasty

Locations

Country	Name	City	State
France	Hôpital Privé Jean Mermoz	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

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