Therapy of Fifth Metacarpal Neck Fractures - Comparing Functional Treatment With Reposition and Finger Splinting

Study Overview
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Brief Summary
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The purpose of this prospective randomized controlled clinical trial is to evaluate if functional treatment leads to a better functional outcome than a forearm cast and a finger splint in patients with fifth metacarpal neck fracture.

Detailed Description
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This study represents a prospective randomized clinical trial comparing two different conservative treatment options in patients with fifth metacarpal neck fracture. Patients meeting the inclusion criteria will be enrolled in the present study provided they give their consent. Informed written consent will be obtained. Randomization will be performed according to the CONSORT Guidelines of Prospective Randomized Trials using the software Randomizer by the Medical University of Graz. Patients allocated to the control group will receive a forearm cast with a finger splint in terms of an immobilizing treatment, while patients in the study group will receive buddy taping for fingers IV and V and an elastic bandage in terms of a functional treatment. Both groups will receive the allocated bandage or splint for 4 weeks. The clinical outcome will be assessed 12 weeks after trauma.

Official Title
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Conservative Therapy of Fifth Metacarpal Neck Fractures - a Prospective Randomized Study Comparing Functional Treatment With Reposition and Finger Splinting

Conditions
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Boxer's Fracture

Intervention / Treatment
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* Procedure: Functional Treatment
* Procedure: Forearm Cast and Finger Splint


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fifth Metacarpal Neck Fractures Patient age between 18 and 70 years Exclusion Criteria: Palmar angulation >50° in first lateral x-ray Pathologic fracture Intraarticular fracture Patients unable to consent Polytraumatized patients Pregnancy Compound fractures Multiple hand injuries Patients initially presenting more than 7 days after injury

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Functional Treatment<br> | Procedure: Functional Treatment<br>* Patients receiving buddy taping for fingers IV and V and an elastic bandage in terms of a functional treatment. Duration of bandage treatment is determined with 4 weeks.<br>|
| Active Comparator: Forearm Cast and Finger Splint<br> | Procedure: Forearm Cast and Finger Splint<br>* Patients receiving reduction of fractured finger and subsequent customization of a forearm cast with a finger splint. Duration of cast treatment is determined with 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Michigan-Hand-Outcome-Questionnaire | patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function) | at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loss/Gain of Reduction | changes in palmar angulation of the fracture at end of treatment, compared to first x-ray (in degrees) | at 12 weeks | 
| Treatment Failure | Occurrence of indication for surgery (malrotation, palmar angulation >50°) after primary reposition | at 1, 2, 4 and 12 weeks |