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

Primary Purpose

Boxer's Fracture

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Functional Treatment
Forearm Cast and Finger Splint
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Boxer's Fracture

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Functional Treatment

    Forearm Cast and Finger Splint

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Loss/Gain of Reduction
    changes in palmar angulation of the fracture at end of treatment, compared to first x-ray (in degrees)
    Treatment Failure
    Occurrence of indication for surgery (malrotation, palmar angulation >50°) after primary reposition

    Full Information

    First Posted
    August 26, 2023
    Last Updated
    August 31, 2023
    Sponsor
    Medical University of Vienna
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06029374
    Brief Title
    Therapy of Fifth Metacarpal Neck Fractures - Comparing Functional Treatment With Reposition and Finger Splinting
    Acronym
    BoxerFx
    Official Title
    Conservative Therapy of Fifth Metacarpal Neck Fractures - a Prospective Randomized Study Comparing Functional Treatment With Reposition and Finger Splinting
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    August 2025 (Anticipated)
    Study Completion Date
    February 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of Vienna

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Boxer's Fracture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Functional Treatment
    Arm Type
    Active Comparator
    Arm Title
    Forearm Cast and Finger Splint
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Functional Treatment
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Forearm Cast and Finger Splint
    Intervention Description
    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 Measure Information:
    Title
    Brief Michigan-Hand-Outcome-Questionnaire
    Description
    patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function)
    Time Frame
    at 12 weeks
    Secondary Outcome Measure Information:
    Title
    Loss/Gain of Reduction
    Description
    changes in palmar angulation of the fracture at end of treatment, compared to first x-ray (in degrees)
    Time Frame
    at 12 weeks
    Title
    Treatment Failure
    Description
    Occurrence of indication for surgery (malrotation, palmar angulation >50°) after primary reposition
    Time Frame
    at 1, 2, 4 and 12 weeks
    Other Pre-specified Outcome Measures:
    Title
    Visual Analogue Scale (VAS)
    Description
    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
    Title
    Strength Measurement
    Description
    dynamometer-based strength evaluation
    Time Frame
    at 4 and 12 weeks
    Title
    Range of Motion (ROM) Assessment
    Description
    goniometer-based ROM evaluation of hand and wrist
    Time Frame
    at 4 and 12 weeks
    Title
    Delayed Bone Healing
    Description
    number of participants with bone non-union at end of study
    Time Frame
    at 12 weeks
    Title
    Radiological Outcome
    Description
    x-ray based outcome of fracture healing in terms of axial deviation (measured in °)
    Time Frame
    at 0, 1, 2, 4 and 12 weeks
    Title
    Radiological Outcome
    Description
    x-ray based outcome of fracture healing in terms of length deviation and dislocation (measured in mm)
    Time Frame
    at 0, 1, 2, 4 and 12 weeks
    Title
    Quick DASH-Score
    Description
    patient-based standardised questionnaire (11 items, range 0-100, 100=ideal function, 0=poorest function)
    Time Frame
    at 0, 1, 2, 4 and 12 weeks
    Title
    Brief Michigan-Hand-Outcome-Questionnaire
    Description
    patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function)
    Time Frame
    at 0, 1, 2 and 4 weeks
    Title
    Occurrence of Complications
    Description
    occurence of complications due to treatment
    Time Frame
    at 0, 1, 2, 4 and 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Paul L Hoppe, M.D.
    Phone
    0043 1 40400 59160
    Email
    paul.hoppe@meduniwien.ac.at
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gerhild Thalhammer, M.D.
    Organizational Affiliation
    Medical University of Vienna
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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