Validation of a Surgical Navigation Algorithm During Knee Replacements in Patients With Knee Osteoarthritis
VALALGON
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2021
CompletedFirst Posted
Study publicly available on registry
June 3, 2021
CompletedStudy Start
First participant enrolled
July 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2022
CompletedNovember 18, 2022
November 1, 2022
1 year
June 2, 2021
November 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Validation of navigation algorithm
Comparison between peroperative images and preoperative CT-scan
12 months
Interventions
Images taken during knee replacement surgery will be compared to CT-Scan that was performed before surgery
Eligibility Criteria
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.
You may qualify if:
- Adults patients who signed the ICF of the study
- Patients suffering from knee osteoarthritis requiring a total knee replacement surgery
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ganymed Roboticslead
Study Sites (1)
Hopital prive Jean Mermoz-Ramsay Santé
Lyon, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2021
First Posted
June 3, 2021
Study Start
July 7, 2021
Primary Completion
July 8, 2022
Study Completion
July 8, 2022
Last Updated
November 18, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share