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

NCT ID: NCT05435690

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-06

Study Completion Date

2026-05-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Gonarthrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-blind, randomised, prospective comparative study in two parallel groups (conventional or computer-assisted arthroplasty).
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Computer-assisted arthroplasty

Group Type EXPERIMENTAL

Computer-assisted arthroplasty

Intervention Type DEVICE

Computer-assisted arthroplasty

Conventional arthroplasty

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Computer-assisted arthroplasty

Computer-assisted arthroplasty

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Privé Jean Mermoz

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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2021-A01677-34

Identifier Type: -

Identifier Source: org_study_id

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