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NOT YET RECRUITING
NCT05233930
NA

Total Knee Arthroplasty and Augmented Reality-based Navigation System

Sponsor: Elsan

View on ClinicalTrials.gov

Summary

The purpose of Total Knee Replacement (TKR) is to remove worn cartilage surfaces and replace them with artificial parts of the same shape. TKR can be used in cases of osteoarthritis, inflammatory rheumatism, bone necrosis of the knee or following malformative or traumatic sequelae. Implant alignment is paramount in TKR and the last years have seen a proliferation of alignment techniques following the introduction of computer and robotic-assisted surgery. Among Computer-assisted surgery, the augmented reality-based navigation system can be an option to improve accuracy in orthopaedic surgery. The hypothesis of this study is: the use of augmented reality-based navigation system allows a prosthesis alignment and positioning that is at least as good as with the traditional mechanically aligned technique, and therefore improves knee functional results. This study also aims at assessing the cost-effectiveness of this new technology.

Official title: Does an Augmented Reality-based Navigation System in Total Knee Arthroplasty Allow a Better Alignment of the Lower Limb and Does it Improve Functional Results ? An Equivalence, Monocentric, Prospective and Randomized Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

88

Start Date

2024-09

Completion Date

2025-10

Last Updated

2024-06-18

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

TKR with augmented reality-based navigation system

Surgery

PROCEDURE

TKR with traditional mechanically aligned technique

As per local practice and standard guidelines.

Locations (1)

Centre Médico-Chirurgical de Tronquières

Aurillac, France