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Miniplate Versus k Wires in Management of Metacarpal Fracture

Primary Purpose

Metacarpal Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
miniplate
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metacarpal Fracture

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age: ( 20-60) years,
  2. Fresh (fixed within 3 days),
  3. Single or multiple fractures of metacarpals.

Exclusion Criteria:

  1. Pathological fracture,
  2. Major systemic illness, malignancy,
  3. Patient on drugs affecting fracture healing like steroid, anticancer drugs,
  4. Polytrauma patients,
  5. Extensive comminution of the metacarpal or phalanx detected pre- or intra-operatively,
  6. Dislocations at either end of the fractured bone
  7. Parents/guardians/patients not willing to participate in study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    group one

    gruop two

    Arm Description

    patient with metacarpal fracture that will use minipate for fixation

    patient with metacarpal fracture that will use buried k wires for fixation

    Outcomes

    Primary Outcome Measures

    miniplate,buried k wires and union
    • To compare between union and healing in metacarpal fracture fixation by miniplate versus buried intramedullary k. wires by imaging using anteroposterior and lateral and oblique views x ray to determine union and healing by seeing bridging callus in two or more cortices

    Secondary Outcome Measures

    Range of motion
    • Range of motion using Functional range of motion (FROM) is defined as the minimum ROM necessary to comfortably and effectively perform ADL.

    Full Information

    First Posted
    September 12, 2020
    Last Updated
    October 21, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04605341
    Brief Title
    Miniplate Versus k Wires in Management of Metacarpal Fracture
    Official Title
    Comparative Study Between Miniplate and Buried k Wires in Management of Metacarpal Fractures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2021 (Anticipated)
    Primary Completion Date
    November 30, 2022 (Anticipated)
    Study Completion Date
    December 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

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

    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
    To compare between buried k wires and miniplate in management of metacarpal fracture.
    Detailed Description
    Fractures of the carpals, metacarpals and phalanges account for approximately 15-19% of fractures in adults, with 59% of these occurring in the phalanges, 33% in the metacarpals and 8% in the carpal bones [1]. The single most common fracture site in the hand is the sub capital region of the fifth metacarpal bone (boxer's fracture) [2], which usually results from a direct blow to the metacarpal head [3]. Most hand fractures are caused by accidental falls or other sports-related injuries [4]. Hand fractures are among the most common fractures of upper extremity [5, 6]. Hand fractures can be treated conservatively or surgically, depending on the severity, location and type of fracture. The main objective of both operative and non-operative treatments is to provide fracture stability for early mobilization [7]. Surgical fixation is mainly indicated for displaced fractures because casts are often not sufficient to maintain reduction [8]. Open reduction with internal fixation (ORIF), using pins or plates, has historically been used to stabilize hand fractures which have rotational deformity or lateral angulation [9]. Open reduction may result in scarring, joint stiffness and tendon adhesion [7]. Closed reduction with internal fixation (CRIF), using percutaneous K wire or screws, is now used to treat the majority of unstable closed simple hand fractures [10]. It is generally considered percutaneous Kirschner wire (K wire) fixation may not provide adequate stabilization to allow for early mobilization [8] .

    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
    Care Provider
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group one
    Arm Type
    Active Comparator
    Arm Description
    patient with metacarpal fracture that will use minipate for fixation
    Arm Title
    gruop two
    Arm Type
    Active Comparator
    Arm Description
    patient with metacarpal fracture that will use buried k wires for fixation
    Intervention Type
    Device
    Intervention Name(s)
    miniplate
    Other Intervention Name(s)
    k wires
    Intervention Description
    comparison between k wires and miniplate in metacarpal fractures
    Primary Outcome Measure Information:
    Title
    miniplate,buried k wires and union
    Description
    • To compare between union and healing in metacarpal fracture fixation by miniplate versus buried intramedullary k. wires by imaging using anteroposterior and lateral and oblique views x ray to determine union and healing by seeing bridging callus in two or more cortices
    Time Frame
    6 month
    Secondary Outcome Measure Information:
    Title
    Range of motion
    Description
    • Range of motion using Functional range of motion (FROM) is defined as the minimum ROM necessary to comfortably and effectively perform ADL.
    Time Frame
    6 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age: ( 20-60) years, Fresh (fixed within 3 days), Single or multiple fractures of metacarpals. Exclusion Criteria: Pathological fracture, Major systemic illness, malignancy, Patient on drugs affecting fracture healing like steroid, anticancer drugs, Polytrauma patients, Extensive comminution of the metacarpal or phalanx detected pre- or intra-operatively, Dislocations at either end of the fractured bone Parents/guardians/patients not willing to participate in study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    mina kamal, resident
    Phone
    01203380329
    Email
    minakamalcr7@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    kamal elgafary, professor
    Phone
    01223144899
    Email
    Kamalelgafary@yahoo.com

    12. IPD Sharing Statement

    Learn more about this trial

    Miniplate Versus k Wires in Management of Metacarpal Fracture

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