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NCT Number: NCT06029374

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

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.

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Key information

Conditions

Boxer's Fracture

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna - Department of Orthopedics and Trauma-Surgery

Vienna, 1090, Austria

Location status: Recruiting

Location contact

Paul Hoppe, M.D.

CONTACT

[email protected]

+4314040059160

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional Treatment

Procedure

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

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 outcomes

  1. Brief Michigan-Hand-Outcome-Questionnaire

    Time frame: at 12 weeks

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

Secondary outcomes

  1. Loss/Gain of Reduction

    Time frame: at 12 weeks

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

  2. Treatment Failure

    Time frame: at 1, 2, 4 and 12 weeks

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

Other outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: at 0, 1, 2, 4 and 12 weeks

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

  2. Strength Measurement

    Time frame: at 4 and 12 weeks

    dynamometer-based strength evaluation

  3. Range of Motion (ROM) Assessment

    Time frame: at 4 and 12 weeks

    goniometer-based ROM evaluation of hand and wrist

  4. Delayed Bone Healing

    Time frame: at 12 weeks

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

  5. Radiological Outcome

    Time frame: at 0, 1, 2, 4 and 12 weeks

    x-ray based outcome of fracture healing in terms of axial deviation (measured in degrees)

  6. Radiological Outcome

    Time frame: at 0, 1, 2, 4 and 12 weeks

    x-ray based outcome of fracture healing in terms of length deviation and dislocation (measured in mm)

  7. Quick DASH-Score

    Time frame: at 0, 1, 2, 4 and 12 weeks

    patient-based standardised questionnaire (11 items, range 0-100, 100=ideal function, 0=poorest function)

  8. Brief Michigan-Hand-Outcome-Questionnaire

    Time frame: at 0, 1, 2 and 4 weeks

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

  9. Occurrence of Complications

    Time frame: at 0, 1, 2, 4 and 12 weeks

    occurence of complications due to treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Paul L Hoppe, M.D.

CONTACT

[email protected]

0043 1 40400 59160

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Acronym: BoxerFx

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Sep 8, 2023
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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