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CompletedNCT04912908VALALGONUpdated Nov 18, 2022

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

An observational study in Osteoarthritis, Knee, sponsored by Ganymed Robotics. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-18.

Sponsored by Ganymed Robotics · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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).

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Conditions studied

  • Osteoarthritis, Knee
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In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 100 is close to the median of 100 across 791 observational studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

This is the only study on the registry with Ganymed Robotics as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • Adults patients who signed the ICF of the study
  • Patients suffering from knee osteoarthritis requiring a total knee replacement surgery

Exclusion criteria

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.
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Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Interventions

  • OtherImages taken during knee replacement surgery

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

    Also known as: CT-Scan before knee replacement surgery

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What researchers measure

Primary outcomes

  1. Validation of navigation algorithm

    Comparison between peroperative images and preoperative CT-scan

    Time frame: 12 months

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Study locations

1 site
  • Hopital prive Jean Mermoz-Ramsay Santé
    Lyon, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04912908
Lead sponsor
Ganymed Robotics
Responsible party
Sponsor
First posted
Jun 3, 2021
Start date
Jul 7, 2021
Primary completion
Jul 8, 2022
Completion
Jul 8, 2022
Last update
Nov 18, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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