NCT00704002

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 24, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

March 29, 2013

Status Verified

March 1, 2013

Enrollment Period

3.2 years

First QC Date

June 23, 2008

Last Update Submit

March 27, 2013

Conditions

Fifth Metacarpal Neck Fracture

Keywords

neck fracture of the fifth metacarpaldisplacementantegrade intramedullary splintingconservative treatment

Outcome Measures

Primary Outcomes (1)

  • Disability of the Arm, Shoulder and Hand (DASH) questionnaire

    3 months

Secondary Outcomes (1)

  • pain

    3 months

Study Arms (2)

A

EXPERIMENTAL

antegrade intramedullary splinting

Procedure: antegrade intramedullary splinting

B

ACTIVE COMPARATOR

conservative treatment

Procedure: conservative treatment

Interventions

antegrade intramedullary splintingPROCEDURE

antegrade intramedullary splinting with 2 to 3 small K-wires

A
conservative treatmentPROCEDURE

conservative treatment with 2-finger splint for one week

B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • displaced neck fracture of the fifth metacarpal (at least 30° angulation)
  • isolated injury
  • age between 18 and 75 years
  • informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Trauma and Hand Surgery

Düsseldorf, D-40225, Germany

Location

MeSH Terms

Interventions

Conservative Treatment

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Michael Schädel-Höpfner, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2008

First Posted

June 24, 2008

Study Start

December 1, 2006

Primary Completion

February 1, 2010

Study Completion

June 1, 2010

Last Updated

March 29, 2013

Record last verified: 2013-03

Locations

DE(1)