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

March 27, 2013 updated by: Heinrich-Heine University, Duesseldorf
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.

Study Overview

Status

Terminated

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Düsseldorf, Germany, D-40225
        • Department of Trauma and Hand Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
antegrade intramedullary splinting
Procedure: antegrade intramedullary splinting
antegrade intramedullary splinting with 2 to 3 small K-wires
ACTIVE_COMPARATOR: B
conservative treatment
Procedure: conservative treatment
conservative treatment with 2-finger splint for one week

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
pain
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Investigators

  • Principal Investigator: Michael Schädel-Höpfner, MD, Department of Trauma and Hand Surgery, University Hospital, Düsseldorf, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

June 23, 2008

First Submitted That Met QC Criteria

June 23, 2008

First Posted (ESTIMATE)

June 24, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 29, 2013

Last Update Submitted That Met QC Criteria

March 27, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CONFraM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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