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

Boxer's Fracture Clinical Trial

— BoxerFx  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06029374
• Other study ID #: 1529/2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: February 2026

Study information

• Verified date: August 2023
• Source: Medical University of Vienna
• Contact: Paul L Hoppe, M.D.
• Phone: 0043 1 40400 59160
• Email: paul.hoppe[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Boxer's Fracture
• Fractures, Bone

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visual Analogue Scale (VAS)	Pain evaluation on a psychometric response scale (range 0-10, 0=no pain, 10=maximum pain)	at 0, 1, 2, 4 and 12 weeks
Other	Strength Measurement	dynamometer-based strength evaluation	at 4 and 12 weeks
Other	Range of Motion (ROM) Assessment	goniometer-based ROM evaluation of hand and wrist	at 4 and 12 weeks
Other	Delayed Bone Healing	number of participants with bone non-union at end of study	at 12 weeks
Other	Radiological Outcome	x-ray based outcome of fracture healing in terms of axial deviation (measured in °)	at 0, 1, 2, 4 and 12 weeks
Other	Radiological Outcome	x-ray based outcome of fracture healing in terms of length deviation and dislocation (measured in mm)	at 0, 1, 2, 4 and 12 weeks
Other	Quick DASH-Score	patient-based standardised questionnaire (11 items, range 0-100, 100=ideal function, 0=poorest function)	at 0, 1, 2, 4 and 12 weeks
Other	Brief Michigan-Hand-Outcome-Questionnaire	patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function)	at 0, 1, 2 and 4 weeks
Other	Occurrence of Complications	occurence of complications due to treatment	at 0, 1, 2, 4 and 12 weeks
Primary	Brief Michigan-Hand-Outcome-Questionnaire	patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function)	at 12 weeks
Secondary	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
Secondary	Treatment Failure	Occurrence of indication for surgery (malrotation, palmar angulation >50°) after primary reposition	at 1, 2, 4 and 12 weeks