Comparison of Self-inflicted Deep Wrist Injuries to Traum... | NCT03038581

Studies
Comparison of Self-inflicted Deep Wrist Injuries to Traumatic Deep Wrist Injuries

NCT03038581

Sponsor

University Hospital Schleswig-Holstein

Status

Completed

Last Update Posted

Dec 3, 2019Actual

Enrollment

183Actual

Phase

Not provided

Conditions

Deep Wound
Wrist Injuries

Interventions

Not provided

Countries

Germany

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

ID	Type	Description	Link
U1111-1176-0115	Other Identifier	WHO

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015Actual

Primary Completion Date

Sep 2018Actual

Completion Date

Sep 2018Actual

First Submitted Date

Oct 29, 2015

First Submission Date that Met QC Criteria

Jan 28, 2017

First Posted Date

Jan 31, 2017Estimated

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

Dec 1, 2019

Last Update Posted Date

Dec 3, 2019Actual

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

Self-inflicted wrist injuries require special psychiatric knowledge and tactical skills. There is no protocol for treating such injuries. We analyze self-inflicted wrist injuries and compare them to traumatic wrist injuries.

Detailed Description

Self-inflicted wrist injuries are regularly treated in hand surgery centers. These injuries involve risks that require special psychiatric knowledge and tactical skills. There is no protocol for treating such injuries. Therefore, the investigators analyze self-inflicted wrist injuries and compare them to traumatic wrist injuries.

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

183Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Self-inflicted wrist injury		Wrist injury by self-infliction
Traumatic wrist injury		Wrist injury by not self-inflicted trauma

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hand function	Assessment of hand function by measuring sensibility (2-point-discrimination) and motoric (degree joints)	Up to 10 years

Secondary Outcomes

Measure	Description	Time Frame
Psychiatric history	Assessment of quality of life	Up to 10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Deep wrist injury from 2008-2018
Treated in University Hospital Schleswig-Holstein
Agreed to retrospective analysis, questionnaires and hand function assessment

Exclusion Criteria:

Non-compliance

Accepts Healthy Volunteers

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

Patients with deep wrist injuries that were treated 2008-2018 in University Hospital Schleswig-Holstein

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tobias Kisch, MD	University of Schleswig-Holstein, Campus Lübeck, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Schleswig-Holstein		Lübeck	Schleswig-Holstein	23538	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014954	Wrist Injuries

Ancestor Terms

ID	Term
D001134	Arm Injuries
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided