Osteoarthritis, KneeVALALGONNCT04912908
Validation of a Surgical Navigation Algorithm During Knee Replacements in Patients With Knee Osteoarthritis
An observational study of Osteoarthritis, Knee, run by Ganymed Robotics at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Images taken during knee replacement surgery
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jul 2021to 8 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults patients who signed the ICF of the study
- Patients suffering from knee osteoarthritis requiring a total knee replacement surgery
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Osteoarthritis, Knee
- Being tested
- Images taken during knee replacement surgery
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Images taken during knee replacement surgeryOther
Also called CT-Scan before knee replacement surgery
Images taken during knee replacement surgery will be compared to CT-Scan that was performed before surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of navigation algorithm
Comparison between peroperative images and preoperative CT-scan
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start7 Jul 2021
- Primary completion8 Jul 2022
- Study completion8 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ganymed Robotics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912908
- Sponsor's protocol ID
- 2021-A00961-40
- Acronym
- VALALGON
- Status last verified
- Nov 2022
- First submitted
- 2 Jun 2021
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Surgical Navigation Algorithm During Knee Replacements in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04912908
- Acronym / sponsor ID
- VALALGON / 2021-A00961-40
- Conditions
- Osteoarthritis, Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ganymed RoboticsIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 8 Jul 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Adults patients who signed the ICF of the study
- Patients suffering from knee osteoarthritis requiring a total knee replacement surgery
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Images taken during knee replacement surgeryAlso: CT-Scan before knee replacement surgeryImages taken during knee replacement surgery will be compared to CT-Scan that was performed before surgery | Other | – |
Primary outcome
Validation of navigation algorithm
Time frame: 12 months
Comparison between peroperative images and preoperative CT-scan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Ganymed Robotics at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of navigation algorithm (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022.