ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00704002
Recruitment Status : Terminated
First Posted : June 24, 2008
Last Update Posted : March 29, 2013
Sponsor:
Information provided by (Responsible Party):
Heinrich-Heine University, Duesseldorf

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.

Condition or disease Intervention/treatment Phase
Fifth Metacarpal Neck Fracture Procedure: antegrade intramedullary splinting Procedure: conservative treatment Not Applicable

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  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Conservative Versus Operative Treatment of Displaced Neck Fractures of the Fifth Metacarpal
Study Start Date : December 2006
Actual Primary Completion Date : February 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

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




Primary Outcome Measures :
  1. Disability of the Arm, Shoulder and Hand (DASH) questionnaire [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. pain [ Time Frame: 3 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00704002


Locations
Germany
Department of Trauma and Hand Surgery
Düsseldorf, Germany, D-40225
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
Principal Investigator: Michael Schädel-Höpfner, MD Department of Trauma and Hand Surgery, University Hospital, Düsseldorf, Germany

Responsible Party: Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT00704002     History of Changes
Other Study ID Numbers: CONFraM
First Posted: June 24, 2008    Key Record Dates
Last Update Posted: March 29, 2013
Last Verified: March 2013

Keywords provided by Heinrich-Heine University, Duesseldorf:
neck fracture of the fifth metacarpal
displacement
antegrade intramedullary splinting
conservative treatment

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries