Conservative Versus Operative Treatment of Displaced Neck Fractures of the Fifth Metacarpal - Full Text View

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

This study is currently recruiting participants.

Verified by Heinrich-Heine University, Duesseldorf, June 2008

First Received: June 23, 2008 No Changes Posted

Sponsored by:	Heinrich-Heine University, Duesseldorf
Information provided by:	Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:	NCT00704002

Purpose

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.

Condition	Intervention
Fifth Metacarpal Neck Fracture	Procedure: antegrade intramedullary splinting Procedure: conservative treatment

MedlinePlus related topics: Fractures

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Conservative Versus Operative Treatment of Displaced Neck Fractures of the Fifth Metacarpal

Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:

Disability of the Arm, Shoulder and Hand (DASH) questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	December 2006
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental antegrade intramedullary splinting	Procedure: antegrade intramedullary splinting antegrade intramedullary splinting with 2 to 3 small K-wires
B: Active Comparator conservative treatment	Procedure: conservative treatment conservative treatment with 2-finger splint for one week

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704002

Contacts

Contact: Michael Schädel-Höpfner, MD

49-211-810-4400

schaedel@uni-duesseldorf.de

Locations

Germany
Department of Trauma and Hand Surgery	Recruiting
Düsseldorf, Germany, D-40225
Contact: Michael Schädel-Höpfner, MD 49-211-810-4400 schaedel@uni-duesseldorf.de

Sponsors and Collaborators

Heinrich-Heine University, Duesseldorf

Investigators

Principal Investigator:

Michael Schädel-Höpfner, MD

Department of Trauma and Hand Surgery, University Hospital, Düsseldorf, Germany

More Information

No publications provided

Responsible Party:	Research Commission, Heinrich-Heine University, Düsseldorf ( Heinrich-Heine University, Düsseldorf )
Study ID Numbers:	CONFraM
Study First Received:	June 23, 2008
Last Updated:	June 23, 2008
ClinicalTrials.gov Identifier:	NCT00704002 History of Changes
Health Authority:	Germany: Ethics Commission

Keywords provided by Heinrich-Heine University, Duesseldorf:

neck fracture of the fifth metacarpal
displacement
antegrade intramedullary splinting
conservative treatment

Study placed in the following topic categories:

Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin

Additional relevant MeSH terms:

Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on May 06, 2009