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NCT04912908 Clinical Trial

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

Osteoarthritis, Knee Clinical Trial

— VALALGON  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04912908
Other study ID # 2021-A00961-40
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 7, 2021
Est. completion date July 8, 2022

Study information
Verified date November 2022
Source Ganymed Robotics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date July 8, 2022
Est. primary completion date July 8, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Hopital prive Jean Mermoz-Ramsay Santé Lyon

Sponsors (1)
Lead Sponsor Collaborator
Ganymed Robotics

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Validation of navigation algorithm Comparison between peroperative images and preoperative CT-scan 12 months
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