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

NCT05435690 | Active Not Recruiting

• 1 other identifier: 2021-A01677-34
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gonarthrosis

Outcome Measures

Primary Outcomes (1)

• KSS M12

  Assessment of functional outcome at 12 months by Knee Scoring System (KSS) score

  Month 12

Secondary Outcomes (12)

• KSS M3

  Month 3

• KOOS JR M3

  Month 3

• KOOS JR M12

  Month 12

• EQ-5D M3

  Month 3

• EQ-5D M12

  Month 12

Study Arms (2)

Computer-assisted arthroplasty

EXPERIMENTAL

Device: Computer-assisted arthroplasty

Conventional arthroplasty

NO INTERVENTION

Interventions

Computer-assisted arthroplasty DEVICE

Computer-assisted arthroplasty

Computer-assisted arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Hôpital Privé Jean Mermoz

Lyon, 69008, France

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-blind, randomised, prospective comparative study in two parallel groups (conventional or computer-assisted arthroplasty).

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: June 28, 2022
• Study Start: January 6, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)