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Comparative Study of Postieror Ankle Fracture

Primary Purpose

Postieror Malleolar Fracture, Treatment

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Plate fixation
Screw fixation
Sponsored by
Shanghai Tongji Hospital, Tongji University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postieror Malleolar Fracture

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

supination-external rotation Ⅳ type injury

Exclusion Criteria:

Pion fracture; Isolated posterior ankle fracture.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    plate group

    screw group

    Arm Description

    internal fixation with the plate

    internal fixation with the screw

    Outcomes

    Primary Outcome Measures

    functional score
    AOFAS function score for ankle

    Secondary Outcome Measures

    Full Information

    First Posted
    February 22, 2017
    Last Updated
    February 22, 2017
    Sponsor
    Shanghai Tongji Hospital, Tongji University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03064386
    Brief Title
    Comparative Study of Postieror Ankle Fracture
    Official Title
    Comparative Study of Postieror Malleolar Fracture With Plate and Screw Fixation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 28, 2017 (Anticipated)
    Primary Completion Date
    February 28, 2019 (Anticipated)
    Study Completion Date
    February 28, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai Tongji Hospital, Tongji University School of Medicine

    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 the clinical efficacy of open reduction and internal fixation (ORIF) with plate and screw for postieror malleolar fractures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postieror Malleolar Fracture, Treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    plate group
    Arm Type
    Experimental
    Arm Description
    internal fixation with the plate
    Arm Title
    screw group
    Arm Type
    Experimental
    Arm Description
    internal fixation with the screw
    Intervention Type
    Procedure
    Intervention Name(s)
    Plate fixation
    Intervention Description
    internal fixation with the plate
    Intervention Type
    Procedure
    Intervention Name(s)
    Screw fixation
    Intervention Description
    internal fixation with the screw
    Primary Outcome Measure Information:
    Title
    functional score
    Description
    AOFAS function score for ankle
    Time Frame
    One year after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: supination-external rotation Ⅳ type injury Exclusion Criteria: Pion fracture; Isolated posterior ankle fracture.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yunfeng Yang, Ph.D.
    Phone
    +86 13918588939

    12. IPD Sharing Statement

    Learn more about this trial

    Comparative Study of Postieror Ankle Fracture

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