Evaluation of a New Navigation System in Computer-assiste... | NCT05435690

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

NCT05435690

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status

Active, not recruiting

Last Update Posted

Dec 3, 2025Actual

Enrollment

126Estimated

Phase

Not Applicable

Conditions

Gonarthrosis

Interventions

Computer-assisted arthroplasty

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 6, 2023Actual

Primary Completion Date

May 31, 2026Estimated

Completion Date

May 31, 2026Estimated

First Submitted Date

Dec 14, 2021

First Submission Date that Met QC Criteria

Jun 22, 2022

First Posted Date

Jun 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2025

Last Update Posted Date

Dec 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

126Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Computer-assisted arthroplasty	Experimental		Device: Computer-assisted arthroplasty
Conventional arthroplasty	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Computer-assisted arthroplasty	Device	Computer-assisted arthroplasty	Computer-assisted arthroplasty

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
KSS M12	Assessment of functional outcome at 12 months by Knee Scoring System (KSS) score	Month 12

Secondary Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Privé Jean Mermoz		Lyon		69008	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided