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Conservative Versus Operative Treatment of Displaced Neck Fractures of the Fifth Metacarpal (CONFraM)

Primary Purpose

Fifth Metacarpal Neck Fracture

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
antegrade intramedullary splinting
conservative treatment
Sponsored by
Heinrich-Heine University, Duesseldorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fifth Metacarpal Neck Fracture focused on measuring neck fracture of the fifth metacarpal, displacement, antegrade intramedullary splinting, conservative treatment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Trauma and Hand Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

antegrade intramedullary splinting

conservative treatment

Outcomes

Primary Outcome Measures

Disability of the Arm, Shoulder and Hand (DASH) questionnaire

Secondary Outcome Measures

pain

Full Information

First Posted
June 23, 2008
Last Updated
March 27, 2013
Sponsor
Heinrich-Heine University, Duesseldorf
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1. Study Identification

Unique Protocol Identification Number
NCT00704002
Brief Title
Conservative Versus Operative Treatment of Displaced Neck Fractures of the Fifth Metacarpal
Acronym
CONFraM
Official Title
Conservative Versus Operative Treatment of Displaced Neck Fractures of the Fifth Metacarpal
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Study Start Date
December 2006 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heinrich-Heine University, Duesseldorf

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fifth Metacarpal Neck Fracture
Keywords
neck fracture of the fifth metacarpal, displacement, antegrade intramedullary splinting, conservative treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
antegrade intramedullary splinting
Arm Title
B
Arm Type
Active Comparator
Arm Description
conservative treatment
Intervention Type
Procedure
Intervention Name(s)
antegrade intramedullary splinting
Intervention Description
antegrade intramedullary splinting with 2 to 3 small K-wires
Intervention Type
Procedure
Intervention Name(s)
conservative treatment
Intervention Description
conservative treatment with 2-finger splint for one week
Primary Outcome Measure Information:
Title
Disability of the Arm, Shoulder and Hand (DASH) questionnaire
Time Frame
3 months
Secondary Outcome Measure Information:
Title
pain
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Schädel-Höpfner, MD
Organizational Affiliation
Department of Trauma and Hand Surgery, University Hospital, Düsseldorf, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Trauma and Hand Surgery
City
Düsseldorf
ZIP/Postal Code
D-40225
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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