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Search / Trial NCT05233930

Total Knee Arthroplasty and Augmented Reality-based Navigation System

Launched by ELSAN · Jan 31, 2022

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Tkr: Total Knee Replacement

ClinConnect Summary

This clinical trial is studying a new technology called an augmented reality-based navigation system to help improve the accuracy of Total Knee Replacement (TKR) surgeries for patients with gonarthrosis, which is a painful condition affecting the knee. The goal is to see if this new system can align and position the artificial knee parts as well as or better than traditional methods, which could lead to better recovery and knee function after surgery. The trial will also look at whether using this technology is cost-effective compared to standard techniques.

To be eligible for the study, participants must be at least 18 years old and diagnosed with gonarthrosis affecting a specific type of knee alignment, requiring a Total Knee Replacement. However, certain conditions, like having a history of specific knee surgeries or other significant joint issues, would exclude someone from participating. Those who join the trial will have the opportunity to receive care using this innovative technology, and their experiences will help determine its effectiveness for future patients.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Gonarthrosis on a varum knee requiring a Total Knee Replacement
  • 2. Female or male, 18 years of age or older
  • 3. Affiliation to a social security scheme
  • 4. Patient has been informed of the study and has signed an informed consent form
  • Exclusion Criteria:
  • 1. Osteonecrosis,
  • 2. Post traumatic osteoarthritis with femoral or tibial callus,
  • 3. History of tibial or femoral osteotomy,
  • 4. Valgum knee,
  • 5. Isolated patellofemoral osteoarthritis,
  • 6. Significant hip dysplasia or other excessive pelvic deformity,
  • 7. Patient already equipped with medical devices that may conflict with the instrumentation required for augmented reality navigation,
  • 8. Pregnant or breastfeeding women,
  • 9. Patients under legal protection.

About Elsan

Elsan is a leading healthcare organization specializing in the management and operation of private medical facilities, with a strong focus on enhancing patient care and clinical outcomes. With a commitment to innovation and excellence, Elsan conducts clinical trials that advance medical research and treatment options across various therapeutic areas. The organization emphasizes collaboration with healthcare professionals and researchers to ensure rigorous study design and ethical standards, ultimately aiming to contribute valuable insights to the medical community and improve patient health on a broader scale.

Locations

Aurillac, , France

Patients applied

0 patients applied

Trial Officials

Frédéric Dalat, MD

Principal Investigator

Centre Médico-Chirurgical de Tronquières

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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