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Recruiting NCT06029374

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

No phase Interventional Boxer's Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Functional Treatment, Forearm Cast and Finger Splint.
Who it may be relevant to
Registry conditions: Boxer's Fracture. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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.

Interventions

  • Procedure Functional Treatment
    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.
  • Procedure Forearm Cast and Finger Splint
    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.

Primary outcome measures

  • Brief Michigan-Hand-Outcome-Questionnaire [Time frame: at 12 weeks]
Secondary outcome measures (2)
  • Loss/Gain of Reduction [Time frame: at 12 weeks]
  • Treatment Failure [Time frame: at 1, 2, 4 and 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Austria · 1 center
  • Medical University of Vienna - Department of Orthopedics and Trauma-Surgery — Vienna

Identifiers

NCT: NCT06029374 · 1529/2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗