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

NCT ID: NCT04912908

Last Updated: 2022-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-07

Study Completion Date

2022-07-08

Brief Summary

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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

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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).

Conditions

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Osteoarthritis, Knee

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Interventions

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Images taken during knee replacement surgery

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

Intervention Type OTHER

Other Intervention Names

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CT-Scan before knee replacement surgery

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ganymed Robotics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hopital prive Jean Mermoz-Ramsay Santé

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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2021-A00961-40

Identifier Type: -

Identifier Source: org_study_id

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