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Buried Intramedullary K-wire Fixation Compared With Plate and Screw Fixation for Metacarpal Fractures in Unstable Extra-Articular Metacarpal Fractures

Primary Purpose

Metacarpal Fracture

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Buried Intramedullary K-wire Fixation
Plate and Screw Fixation
Sponsored by
Prisma Health-Upstate
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metacarpal Fracture

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patient has an unstable extra-articular metacarpal fracture that meets operative indications
  • Informed consent is obtained from the patient or proxy
  • Male or female who are 16 years of age or older

Exclusion Criteria:

  • If the patients range of motion was decreased prior to injury (previous upper extremity injury, osteoarthritis, etc.)
  • Pathological Fracture
  • Greater than 21 days from fracture to definitive open reduction and internal fixation
  • If contamination or wounds from open fractures do not permit standardized buried intramedullary fixation or plate and screw fixation
  • Highly comminuted diaphyseal fractures
  • Articular fractures
  • Multiple fractures involving bones other than another metacarpal in the same upper extremity
  • The patient had a previous upper extremity injury that has limited hand function or finger range of motion

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Buried Intramedullary K-wire Fixation

    Plate and Screw Fixation

    Arm Description

    Patients randomized to buried intramedullary k-wire fixation will undergo a standardized antegrade open reduction and fixation procedure with an intramedullary k-wire.

    Patients randomized to Plate and Screw Fixation will undergo a standardized open reduction and internal fixation with plate and screws. Brand of plate will be left to the operating surgeon's discretion.

    Outcomes

    Primary Outcome Measures

    Disability as measured by Disability of Arm, Shoulder and Hand Score

    Secondary Outcome Measures

    Total Active Motion in degrees
    Measured by goniometer
    Grip Strength
    Disability as measured by Disability of Arm, Shoulder and Hand Score

    Full Information

    First Posted
    March 15, 2016
    Last Updated
    April 26, 2023
    Sponsor
    Prisma Health-Upstate
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02718170
    Brief Title
    Buried Intramedullary K-wire Fixation Compared With Plate and Screw Fixation for Metacarpal Fractures in Unstable Extra-Articular Metacarpal Fractures
    Official Title
    Buried Intramedullary K-wire Fixation Compared With Plate and Screw Fixation in Unstable Extra-Articular Metacarpal Fractures: A Randomized, Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Enrolling by invitation
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    March 2025 (Anticipated)
    Study Completion Date
    March 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Prisma Health-Upstate

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Randomized controlled trial comparing a technique for buried intramedullary k-wire fixation to plate and screw fixation for unstable extra-articular metacarpal fractures.
    Detailed Description
    Metacarpal fractures are a common injury to the hand. Most fractures occur due to direct force from either a axial load to the dorsum of the metacarpophalangeal joint or low energy fall onto an outstretched hand. Many of these fractures can be treated closed with a closed reduction and splinting however, some displaced or angulated fractures require open reduction and internal fixation. Many fixation techniques have been used, however to the investigators knowledge, no one has prospectively randomized patients to compare plate and screw fixation with buried intramedullary k-wire fixation. The purpose of this study is to compare Plate and screw and buried intramedullary fixation, using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire as the primary outcome measured. Secondary outcomes will include total active motion, complications, cost, reoperation rate.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metacarpal Fracture

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Buried Intramedullary K-wire Fixation
    Arm Type
    Experimental
    Arm Description
    Patients randomized to buried intramedullary k-wire fixation will undergo a standardized antegrade open reduction and fixation procedure with an intramedullary k-wire.
    Arm Title
    Plate and Screw Fixation
    Arm Type
    Active Comparator
    Arm Description
    Patients randomized to Plate and Screw Fixation will undergo a standardized open reduction and internal fixation with plate and screws. Brand of plate will be left to the operating surgeon's discretion.
    Intervention Type
    Procedure
    Intervention Name(s)
    Buried Intramedullary K-wire Fixation
    Intervention Type
    Procedure
    Intervention Name(s)
    Plate and Screw Fixation
    Primary Outcome Measure Information:
    Title
    Disability as measured by Disability of Arm, Shoulder and Hand Score
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Total Active Motion in degrees
    Description
    Measured by goniometer
    Time Frame
    3 months
    Title
    Grip Strength
    Time Frame
    3 months
    Title
    Disability as measured by Disability of Arm, Shoulder and Hand Score
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The patient has an unstable extra-articular metacarpal fracture that meets operative indications Informed consent is obtained from the patient or proxy Male or female who are 16 years of age or older Exclusion Criteria: If the patients range of motion was decreased prior to injury (previous upper extremity injury, osteoarthritis, etc.) Pathological Fracture Greater than 21 days from fracture to definitive open reduction and internal fixation If contamination or wounds from open fractures do not permit standardized buried intramedullary fixation or plate and screw fixation Highly comminuted diaphyseal fractures Articular fractures Multiple fractures involving bones other than another metacarpal in the same upper extremity The patient had a previous upper extremity injury that has limited hand function or finger range of motion
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John Millon, MD
    Organizational Affiliation
    Prisma Health-Upstate
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Buried Intramedullary K-wire Fixation Compared With Plate and Screw Fixation for Metacarpal Fractures in Unstable Extra-Articular Metacarpal Fractures

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