Development of Automated Real-time Algorithms for Detecti... | NCT05458921

Studies
Development of Automated Real-time Algorithms for Detection of Dislocation of the Carpus

NCT05458921

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Nov 8, 2023Actual

Enrollment

10,100Estimated

Phase

Not provided

Conditions

Perilunate Dislocation

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

Nov 2023

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

Jun 1, 2022Actual

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Jul 8, 2022

First Submission Date that Met QC Criteria

Jul 13, 2022

First Posted Date

Jul 14, 2022Actual

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

Nov 7, 2023

Last Update Posted Date

Nov 8, 2023Actual

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

Perilunate dislocation of the carpus is a serious lesion of the wrist which is defined by a total loss of contact of the articular surfaces capito-lunar, scapholunate and lunate-triquetral. Rare by its frequency, it represents 5 to 10% of traumatic injuries of the wrist.

Perilunate wrist dislocation is a rare injury that goes unnoticed in 25% of cases. Even with surgical treatment, 50-100% of patients will develop radiocarpal and/or midcarpal osteoarthritis.

Detailed Description

Not provided

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

10,100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retrospective analysis of carpal X-rays for the development of an algorithm to automatically identify the presence of pathology in the carpal anatomical area		Files analysed retrospectively from January 01, 2012 to December 31, 2022 will be examined]

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria :

Major subjects (≥18 years old)
Treated at the University Hospitals of Strasbourg for a carpal dislocation
Presence of carpal radiographs that may indicate the presence of a lesion
Subjects who have not expressed their opposition, after information, to the re-use of their data for the purposes of this research

Exclusion criteria :

Subject having expressed his opposition to participate in the study
Subject under legal protection, guardianship or curatorship

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Major subjects (≥18 years old) treated at the University Hospitals of Strasbourg for a carpal dislocation between 01/01/2012 and 31/12/2022.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Philippe LIVERNEAUX, MD, PhD	Contact	33 3 68 76 52 48		philippe.liverneaux@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR	Contact			said.chayer@chru-strasbourg.fr

Overall Officials

Name	Affiliation	Role
Philippe LIVERNEAUX, MD, PhD	Service de Chirurgie de la main - CHU de Strasbourg - France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Chirurgie de la main - CHU de Strasbourg - France	Recruiting	Strasbourg		67091	France