Conservative Versus Operative Treatment of Displaced Neck... | NCT00704002

Studies
Conservative Versus Operative Treatment of Displaced Neck Fractures of the Fifth Metacarpal

NCT00704002

Sponsor

Heinrich-Heine University, Duesseldorf

Status

Terminated

Last Update Posted

Mar 29, 2013Estimated

Enrollment

9Actual

Phase

Not Applicable

Conditions

Fifth Metacarpal Neck Fracture

Interventions

antegrade intramedullary splinting
conservative treatment

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

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Feb 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Jun 23, 2008

First Submission Date that Met QC Criteria

Jun 23, 2008

First Posted Date

Jun 24, 2008Estimated

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

Mar 27, 2013

Last Update Posted Date

Mar 29, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This is a prospective, randomized, multi-center pilot study of isolated, displaced neck fractures of the fifth metacarpal. The patients are randomly assigned to osteosynthesis with antegrade intramedullary splinting or conservative treatment.

Detailed Description

The aim of this study is to provide criteria for treatment decisions in patients with isolated, displaced neck fractures of the fifth metacarpal. The primary outcome criterion is the functional status measured by the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Secondary outcome criteria are pain, range of motion (ROM), grip strength, and radiological parameters.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	antegrade intramedullary splinting	Procedure: antegrade intramedullary splinting
B	Active Comparator	conservative treatment	Procedure: conservative treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
antegrade intramedullary splinting	Procedure	antegrade intramedullary splinting with 2 to 3 small K-wires	A

Measure	Description	Time Frame
Disability of the Arm, Shoulder and Hand (DASH) questionnaire		3 months

Measure	Description	Time Frame
pain		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

displaced neck fracture of the fifth metacarpal (at least 30° angulation)
isolated injury
age between 18 and 75 years
informed consent

Exclusion Criteria:

rotational displacement
open fracture
injury older than one week
treatment other than within this study
other relevant injuries of the upper extremities
other injury or disease of the hand
pregnancy
missing informed consent
incompliance
coagulopathy
allergy to metallic implants
Patients who have participated in any other device or drug clinical trial within the previous month

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Schädel-Höpfner, MD	Department of Trauma and Hand Surgery, University Hospital, Düsseldorf, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Trauma and Hand Surgery		Düsseldorf		D-40225	Germany