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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT00704002
First received: June 23, 2008
Last updated: March 27, 2013
Last verified: March 2013
History of Changes

June 23, 2008
March 27, 2013
December 2006
February 2010   (final data collection date for primary outcome measure)
Disability of the Arm, Shoulder and Hand (DASH) questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00704002 on ClinicalTrials.gov Archive Site
pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Conservative Versus Operative Treatment of Displaced Neck Fractures of the Fifth Metacarpal
Conservative Versus Operative Treatment of Displaced Neck Fractures of the Fifth Metacarpal

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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Fifth Metacarpal Neck Fracture
  • Procedure: antegrade intramedullary splinting
    antegrade intramedullary splinting with 2 to 3 small K-wires
  • Procedure: conservative treatment
    conservative treatment with 2-finger splint for one week
  • Experimental: A
    antegrade intramedullary splinting
    Intervention: Procedure: antegrade intramedullary splinting
  • Active Comparator: B
    conservative treatment
    Intervention: Procedure: conservative treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
June 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00704002
CONFraM
Yes
Heinrich-Heine University, Duesseldorf
Heinrich-Heine University, Duesseldorf
Not Provided
Principal Investigator: Michael Schädel-Höpfner, MD Department of Trauma and Hand Surgery, University Hospital, Düsseldorf, Germany
Heinrich-Heine University, Duesseldorf
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP