Status:
NOT_YET_RECRUITING
Total Knee Arthroplasty and Augmented Reality-based Navigation System
Lead Sponsor:
Elsan
Conditions:
Gonarthrosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 rheu...
Detailed Description
In this randomised study, TKR will be performed either with the traditional mechanically aligned technique or with an augmented reality-based navigation system using Knee+ technology. Knee+ is a Clas...
Eligibility Criteria
Inclusion
- Gonarthrosis on a varum knee requiring a Total Knee Replacement
- Female or male, 18 years of age or older
- Affiliation to a social security scheme
- Patient has been informed of the study and has signed an informed consent form
Exclusion
- Osteonecrosis,
- Post traumatic osteoarthritis with femoral or tibial callus,
- History of tibial or femoral osteotomy,
- Valgum knee,
- Isolated patellofemoral osteoarthritis,
- Significant hip dysplasia or other excessive pelvic deformity,
- Patient already equipped with medical devices that may conflict with the instrumentation required for augmented reality navigation,
- Pregnant or breastfeeding women,
- Patients under legal protection.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT05233930
Start Date
September 1 2024
End Date
October 1 2025
Last Update
June 18 2024
Active Locations (1)
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1
Centre Médico-Chirurgical de Tronquières
Aurillac, France, 15000