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

November 17, 2022 updated by: Ganymed Robotics
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France
        • Hopital prive Jean Mermoz-Ramsay Santé

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The surgeons involved in the study will propose to all patients corresponding to the eligibility criteria to participate to the study during pre-surgery appointment.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of navigation algorithm
Time Frame: 12 months
Comparison between peroperative images and preoperative CT-scan
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ganymed Robotics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2021

Primary Completion (Actual)

July 8, 2022

Study Completion (Actual)

July 8, 2022

Study Registration Dates

First Submitted

June 2, 2021

First Submitted That Met QC Criteria

June 2, 2021

First Posted (Actual)

June 3, 2021

Study Record Updates

Last Update Posted (Actual)

November 18, 2022

Last Update Submitted That Met QC Criteria

November 17, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A00961-40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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