Multimodal Modeling of the Knee Joint | NCT04179812

Studies
Multimodal Modeling of the Knee Joint

NCT04179812

Sponsor

University Hospital, Brest

Status

Unknown status

Last Update Posted

Jul 2, 2021Actual

Enrollment

210Estimated

Phase

Not provided

Conditions

Knee Arthroplasty

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 16, 2019Actual

Primary Completion Date

Jul 31, 2021Estimated

Completion Date

Jul 31, 2021Estimated

First Submitted Date

Jun 21, 2019

First Submission Date that Met QC Criteria

Nov 25, 2019

First Posted Date

Nov 27, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2021

Last Update Posted Date

Jul 2, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

210Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Inclusion - Day 0

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Targeted patients will be those whose leg image modalities are present in the Brest University Hospital database

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
STINDEL Eric	Contact	+33 (0)2 98 22 38 58		eric.stindel@chu-brest.fr
Dardenne Guillaume	Contact	+33 (0)2 98 01 81 02		guillaume.dardenne@univ-brest.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Brest	Recruiting	Brest		29609	France