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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04912908
Acronym
VALALGON
Enrollment
100
Registered
2021-06-03
Start date
2021-07-07
Completion date
2022-07-08
Last updated
2022-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

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).

Interventions

OTHERImages taken during knee replacement surgery

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

Sponsors

Ganymed Robotics
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Validation of navigation algorithm12 monthsComparison between peroperative images and preoperative CT-scan

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026