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

Completed

• Conditions: Osteoarthritis, Knee

• Registration Number: NCT04912908
• Lead Sponsor: Ganymed Robotics

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-06-02
• Study First Posted: 2021-06-03
• Study Start: 2021-07-07
• Primary Completion: 2022-07-08
• Study Completion: 2022-07-08
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-17
• Last Update Posted: 2022-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation of navigation algorithm	12 months	Comparison between peroperative images and preoperative CT-scan

Trial Locations

Locations (1)

Hopital prive Jean Mermoz-Ramsay Santé; 🇫🇷 Lyon, France