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

H

Heinrich-Heine University, Duesseldorf

Status

Terminated

Conditions

Fifth Metacarpal Neck Fracture

Treatments

Procedure: conservative treatment
Procedure: antegrade intramedullary splinting

Study type

Interventional

Funder types

Other

Identifiers

NCT00704002
CONFraM

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

9 participants in 2 patient groups

A
Experimental group
Description:
antegrade intramedullary splinting
Treatment:
Procedure: antegrade intramedullary splinting
B
Active Comparator group
Description:
conservative treatment
Treatment:
Procedure: conservative treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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