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

ConditionBoxer's Fracture

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-70

SponsorMedical University of Vienna

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fifth Metacarpal Neck Fractures

Patient age between 18 and 70 years

Disqualifiers

Palmar angulation >50° in first lateral x-ray

Pathologic fracture

Intraarticular fracture

Patients unable to consent

Trial design

Design model

Parallel

Treatments tested in this trial

Functional Treatment
Procedure/Surgery
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.
Forearm Cast and Finger Splint
Procedure/Surgery
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.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Functional TreatmentActive comparator 1 intervention

Group B: Forearm Cast and Finger SplintActive comparator 1 intervention

Trial outcomes

Primary outcomes

Brief Michigan-Hand-Outcome-Questionnaire

patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function)

Time frame

at 12 weeks

Secondary outcomes

Loss/Gain of Reduction

changes in palmar angulation of the fracture at end of treatment, compared to first x-ray (in degrees)

Time frame

at 12 weeks

Treatment Failure

Occurrence of indication for surgery (malrotation, palmar angulation \>50°) after primary reposition

Time frame

at 1, 2, 4 and 12 weeks

Other outcomes

Visual Analogue Scale (VAS)

Pain evaluation on a psychometric response scale (range 0-10, 0=no pain, 10=maximum pain)

Time frame

at 0, 1, 2, 4 and 12 weeks

Strength Measurement

dynamometer-based strength evaluation

Time frame

at 4 and 12 weeks

Range of Motion (ROM) Assessment

goniometer-based ROM evaluation of hand and wrist

Time frame

at 4 and 12 weeks

Delayed Bone Healing

number of participants with bone non-union at end of study

Time frame

at 12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Vienna

Lead sponsor

Source ClinicalTrials.gov

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