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

Not Applicable

Not yet recruiting

• Conditions: Boxer's Fracture
• Interventions: Procedure: Forearm Cast and Finger Splint; Procedure: Functional Treatment

• Registration Number: NCT06029374
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-26
• Study First Submitted QC: 2023-08-31
• Last Update Submitted: 2023-08-31
• Study Start: 2023-09
• Study First Posted: 2023-09-08
• Last Update Posted: 2023-09-08
• Primary Completion: 2025-08
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Forearm Cast and Finger Splint	Forearm Cast and Finger Splint	-
Functional Treatment	Functional Treatment	-

Primary Outcome Measures

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

Secondary Outcome Measures

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