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OpenTrials
Completed

NCT Number: NCT04912908

Validation of a Surgical Navigation Algorithm During Knee Replacements in Patients With Knee Osteoarthritis

Ganymed Robotics develops a novel solution of surgical navigation to assist surgeons during knee remplacement surgeries. The aim of this study is to train and validate this novel algorithm.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital prive Jean Mermoz-Ramsay Santé

Lyon, France

About this study

During knee replacement surgery, per-operative images of the patient's knee will be taken. These images will then be compared with the pre-operative CT-scan of the patient using the novel navigation algorithm. The algorithm will be validated based on its ability to correctly compare both modalities (pre-operative and per-operative images).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults patients who signed the ICF of the study
  • Patients suffering from knee osteoarthritis requiring a total knee replacement surgery

Exclusion criteria

  • Patient under the age 18
  • Patient unable to consent to the study or refusing to participate
  • Patient with history of knee replacement on the knee that will be operated again
  • Patient unable to realize a pre-operative CT-scan
  • Patient not covered by French Health insurance or equivalent.

Treatment and study plan

Images taken during knee replacement surgery

Other

Images taken during knee replacement surgery will be compared to CT-Scan that was performed before surgery

Other names: CT-Scan before knee replacement surgery

Primary outcomes

  1. Validation of navigation algorithm

    Time frame: 12 months

    Comparison between peroperative images and preoperative CT-scan

Sponsors and collaborators

Lead sponsor

Ganymed Robotics

Industry

Registry information

Acronym: VALALGON

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 3, 2021
Registry last updated
Nov 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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