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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00704002
Acronym
CONFraM
Enrollment
9
Registered
2008-06-24
Start date
2006-12-31
Completion date
2010-06-30
Last updated
2013-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fifth Metacarpal Neck Fracture

Keywords

neck fracture of the fifth metacarpal, displacement, antegrade intramedullary splinting, conservative treatment

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.

Interventions

PROCEDUREantegrade intramedullary splinting

antegrade intramedullary splinting with 2 to 3 small K-wires

PROCEDUREconservative treatment

conservative treatment with 2-finger splint for one week

Sponsors

Heinrich-Heine University, Duesseldorf
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Disability of the Arm, Shoulder and Hand (DASH) questionnaire3 months

Secondary

MeasureTime frame
pain3 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026