Conservative Versus Operative Treatment of Displaced Neck Fractures of the Fifth Metacarpal

Not Applicable

Terminated

• Conditions: Fifth Metacarpal Neck Fracture
• Interventions: Procedure: antegrade intramedullary splinting; Procedure: conservative treatment

• Registration Number: NCT00704002
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-12
• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-06-23
• Study First Posted: 2008-06-24
• Primary Completion: 2010-02
• Study Completion: 2010-06
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-27
• Last Update Posted: 2013-03-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	antegrade intramedullary splinting	antegrade intramedullary splinting
B	conservative treatment	conservative treatment

Primary Outcome Measures

Name	Time	Method
Disability of the Arm, Shoulder and Hand (DASH) questionnaire	3 months

Secondary Outcome Measures

Name	Time	Method
pain	3 months

Trial Locations

Locations (1)

Department of Trauma and Hand Surgery; 🇩🇪 Düsseldorf, Germany