Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05435690

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Privé Jean Mermoz

Lyon, 69008, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computer-assisted arthroplasty

Device

Computer-assisted arthroplasty

Primary outcomes

  1. KSS M12

    Time frame: Month 12

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

Secondary outcomes

  1. KSS M3

    Time frame: Month 3

    Assessment of functional outcome at 3 months by Knee Scoring System (KSS) score

  2. KOOS JR M3

    Time frame: Month 3

    Functional self-evaluation of the knee joint: Knee injury and Osteoarthritis Outcome Score (KOOS)

  3. KOOS JR M12

    Time frame: Month 12

    Functional self-evaluation of the knee joint: Knee injury and Osteoarthritis Outcome Score (KOOS)

  4. EQ-5D M3

    Time frame: Month 3

    Quality of life evaluation on EuroQol 5D

  5. EQ-5D M12

    Time frame: Month 12

    Quality of life evaluation on EuroQol 5D

  6. FJS M3

    Time frame: Month 3

    Self-evaluation of patient satisfaction with Forgotten Joint Score (FJS)

  7. FJS M312

    Time frame: Month 12

    Self-evaluation of patient satisfaction with Forgotten Joint Score (FJS)

  8. Surgery duration

    Time frame: Day 0

    Surgery duration

  9. Hospitalization duration

    Time frame: Month 1

    Hospitalization duration

  10. Lower limb alignment

    Time frame: Month 12

    Measurement of lower limb alignment in degrees of varus or valgus at M3 and M12

  11. Postoperative outcome predictive factor

    Time frame: Month 1

    Description of a possible correlation between preoperative laxity and postoperative outcome

  12. Safety analysis

    Time frame: Month 12

    Descriptive analysis of adverse events

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: NaviKnee

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 28, 2022
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.