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

Fifth Metacarpal Neck Fracture Clinical Trial

— CONFraM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00704002
• Other study ID #: CONFraM
• Status: Terminated
• Phase: N/A
• First received: June 23, 2008
• Last updated: March 27, 2013
• Start date: December 2006
• Est. completion date: June 2010

Study information

• Verified date: March 2013
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: June 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fifth Metacarpal Neck Fracture
• Fractures, Bone

Intervention

Procedure:
• antegrade intramedullary splinting
antegrade intramedullary splinting with 2 to 3 small K-wires
• conservative treatment
conservative treatment with 2-finger splint for one week

Locations

Country	Name	City	State
Germany	Department of Trauma and Hand Surgery	Düsseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability of the Arm, Shoulder and Hand (DASH) questionnaire		3 months	No
Secondary	pain		3 months	No