Knee ArthroplastyKneeModNCT04179812
Multimodal Modeling of the Knee Joint
An observational study of Knee Arthroplasty, run by University Hospital, Brest at 1 site in France.
Trial summary
The trial will contribute to the development of an innovative algorithm that aims to simplify and improve preoperative knee surgical decision. This will be made by automatically extracting anatomical informations from different images acquired on the patient (scanner, MRI, radiography). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Knee Arthroplasty
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2019to 31 Jul 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Targeted patients will be those whose leg image modalities are present in the Brest University Hospital database
Who may be able to join
- Patients having the 3 modality of images : scanner, MRI, radiography
- Patients having osteoarthritis or knee trauma
- Images showing the articualtion of the knee
- having formulated his non opposition
Who cannot join
- Presentation of a partial view of the knee or any view that does not allow a good segmentation of the total knee joint.
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU de Brest
Brest, 29609
Eric Stindel, eric.stindel@hu-brest.fr
About this study
The trial will contribute to the development of an innovative algorithm that aims to simplify and improve preoperative knee surgical decision. This will be made by automatically extracting anatomical informations from different images acquired on the patient (scanner, MRI, radiography).
Read the detailed description
The source population will consist of at least 50 patients whose following modalities of images of the leg are present in the database: scanner, MRI, radiography. No restrictions on age or gender are required.
A dedicated algorithm adapting statistical models of appearance to the specific morphology of the patient acquired through an MRI and / or scanner and radios will then be developed.
- Conditions
- Knee Arthroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtaining a similar knee segmentation for all patient regardless of the input image (MRI, CT or radiography)
Creation of an algorithm that will automatically segment and provide the same knee anatomical informations for all patients studied regardless of the input image.
This multimodal modeling will be carried out via the exploitation of an active model of appearance type algorithm.
Measured: Inclusion - Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start16 Mar 2019
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179812
- Sponsor's protocol ID
- KneeMod ( 29BRC18.0235)
- Acronym
- KneeMod
- Status last verified
- Jun 2021
- First submitted
- 21 Jun 2019
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Modeling of the Knee Joint
- ClinicalTrials.gov ID
- NCT04179812
- Acronym / sponsor ID
- KneeMod / KneeMod ( 29BRC18.0235)
- Conditions
- Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 16 Mar 2019 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 27 Nov 2019 (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.
The trial will contribute to the development of an innovative algorithm that aims to simplify and improve preoperative knee surgical decision. This will be made by automatically extracting anatomical informations from different images acquired on the patient (scanner, MRI, radiography).
Detailed description
The source population will consist of at least 50 patients whose following modalities of images of the leg are present in the database: scanner, MRI, radiography. No restrictions on age or gender are required.
A dedicated algorithm adapting statistical models of appearance to the specific morphology of the patient acquired through an MRI and / or scanner and radios will then be developed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Targeted patients will be those whose leg image modalities are present in the Brest University Hospital database
Key inclusion criteria (4 listed)
- Patients having the 3 modality of images : scanner, MRI, radiography
- Patients having osteoarthritis or knee trauma
- Images showing the articualtion of the knee
- having formulated his non opposition
Key exclusion criteria (2 listed)
- Presentation of a partial view of the knee or any view that does not allow a good segmentation of the total knee joint.
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Obtaining a similar knee segmentation for all patient regardless of the input image (MRI, CT or radiography)
Time frame: Inclusion - Day 0
Creation of an algorithm that will automatically segment and provide the same knee anatomical informations for all patients studied regardless of the input image. This multimodal modeling will be carried out via the exploitation of an active model of appearance type algorithm.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
Related trials for Knee Arthroplasty
Active, not recruiting
14022 ATTUNE Cementless RP Clinical Performance Evaluation
Osteoarthritis
Not yet recruiting
Patient Satisfaction After Robotic-Assisted Versus Conventional Total Knee Arthroplasty
Osteoarthritis (Knee), Robotic Assisted Arthroplasty
Active, not recruiting
Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
Arthroplasty, Replacement
Active, not recruiting
Healthy Living After Knee Replacement
Arthroplasty, Overweight and Obesity
Active, not recruiting
ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population
Primary Knee Arthroplasty
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.
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 Knee Arthroplasty, run by University Hospital, Brest 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact STINDEL Eric (+33 (0)2 98 22 38 58, eric.stindel@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obtaining a similar knee segmentation for all patient regardless of the input image (MRI, CT or radiography) (time frame: Inclusion - Day 0). 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 2 Jul 2021.