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
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Conservative Versus Operative Treatment of Displaced Neck Fractures of the Fifth Metacarpal

Resource links provided by NLM:


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 ]

Enrollment: 9
Study Start Date: December 2006
Study Completion Date: June 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
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, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT00704002     History of Changes
Other Study ID Numbers: CONFraM
Study First Received: June 23, 2008
Last Updated: March 27, 2013
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on August 01, 2014