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Total Knee Arthroplasty and Augmented Reality-based Navigation System

NCT05233930 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2024-06-18

No results posted yet for this study

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.

Conditions

  • Gonarthrosis

Interventions

PROCEDURE

TKR with augmented reality-based navigation system

Surgery

PROCEDURE

TKR with traditional mechanically aligned technique

As per local practice and standard guidelines.

Sponsors & Collaborators

  • Elsan

    lead OTHER

Principal Investigators

  • Frédéric Dalat, MD · Centre Médico-Chirurgical de Tronquières

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2024-11-30
Completion
2025-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05233930 on ClinicalTrials.gov