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Classification of Ankle Injury Observed With X-ray Combined With Magnetic Resonance Imaging

Primary Purpose

Ankle Injury

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
internal fixation for ankle fractures
Sponsored by
The First Hospital of Hebei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Injury

Eligibility Criteria

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

Inclusion Criteria:

  • Ankle fractures patients detected by X-ray
  • Highly suspected ankle ligament injury
  • History of obvious trauma
  • Complete clinical data
  • Irrespective of sex and age
  • Sign the informed consent

Exclusion Criteria:

  • Cardiopulmonary function cannot tolerate anesthesia or surgery
  • Open fractures of ankle joint
  • Old fracture of the ankle joint

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    internal fixation for ankle fractures

    Arm Description

    The patients with ankle injury underwent internal fixation for ankle fractures and ligament repair. Ankle was observed with X-ray and magnetic resonance imaging preoperatively and 3 months postoperatively.

    Outcomes

    Primary Outcome Measures

    Percentage of patients with excellent effects
    higher value indicates better repair effect

    Secondary Outcome Measures

    patients with Lauge-Hansen classification
    According to the degree of bone and ligament injury, there are supination-external rotation (supination-eversion), pronation-external rotation (pronation-eversion), supination-adduction and pronation-abduction.
    X-ray examination
    To evaluate the healing degree of fracture
    MRI findings
    To evaluate ligament repair effects

    Full Information

    First Posted
    November 16, 2016
    Last Updated
    November 20, 2016
    Sponsor
    The First Hospital of Hebei Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02971943
    Brief Title
    Classification of Ankle Injury Observed With X-ray Combined With Magnetic Resonance Imaging
    Official Title
    Classification of Ankle Injury Observed With X-ray Combined With Magnetic Resonance Imaging: a Retrospective, Self-controlled, Clinical Trial With 3-month Follow-up
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2015 (undefined)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    August 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The First Hospital of Hebei Medical University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To verify whether X-ray combined with MRI is able to carry out correct fracture classification and postoperative evaluation in patients with ankle fractures.
    Detailed Description
    History and current related studies Intraarticular fractures and ruptures of ligaments around the joint often occur after ankle injury. Early correct treatment can effectively help joint repair, and reduce the incidence of serious complications. Ankle fractures are one of the common orthopedic fractures. X-ray is a common method for detecting ankle injury, can determine the fracture site, type and extent. However, X-ray is difficult to display ankle fracture, bone fragments, displacement, or ligament injury, so it cannot make accurate fracture classification or formulate treatment programs. Magnetic resonance imaging (MRI) can clearly show the ankle ligament, tendon, and cartilage injury, is advantageous in the diagnosis of ligament injury after ankle fracture, and can provide accurate imaging information. MRI can provide accurate preoperative assessment of clinical indicators for the rational formulation of treatment programs to reduce complications. The observation of ankle contusion observed by MRI is conducive to analyzing the mechanism of ankle joint injury. Therefore, X-ray combined with MRI would perfectly verify soft tissue injury after ankle fractures so as to make effective surgical program. Adverse events Adverse events including incision pain, incision nonunion, ankle pain, peripheral nerve injury of ankle joint, ankle joint inflammation, and soft tissue injury. Severe adverse events are events occurred during clinical trial, including requiring hospitalization, prolonged hospitalization, disability, inability to work, life-threatening, or fatalities. If severe adverse events occur, investigators would report details, including the date of occurrence and measures taken to treat the adverse events, to the principle investigator and the institutional review board within 24 hours. Data collection, management, analysis and open-access Case report forms with demographic data, disease diagnosis, accompanying diseases, drug allergy history, and adverse events were collected. Data were processed using Epidata software (Epidata Association, Odense, Denmark), collated, and then recorded electronically. All data regarding this trial were preserved by the First Hospital, Hebei Medical University, China. The electronic database was statistically analyzed by a professional statistician who created an outcome analysis report that was submitted to the lead researchers.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ankle Injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    68 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    internal fixation for ankle fractures
    Arm Type
    Other
    Arm Description
    The patients with ankle injury underwent internal fixation for ankle fractures and ligament repair. Ankle was observed with X-ray and magnetic resonance imaging preoperatively and 3 months postoperatively.
    Intervention Type
    Procedure
    Intervention Name(s)
    internal fixation for ankle fractures
    Intervention Description
    The patients with ankle injury underwent internal fixation for ankle fractures and ligament repair. Ankle was observed with X-ray and magnetic resonance imaging.
    Primary Outcome Measure Information:
    Title
    Percentage of patients with excellent effects
    Description
    higher value indicates better repair effect
    Time Frame
    at postoperative 3 months
    Secondary Outcome Measure Information:
    Title
    patients with Lauge-Hansen classification
    Description
    According to the degree of bone and ligament injury, there are supination-external rotation (supination-eversion), pronation-external rotation (pronation-eversion), supination-adduction and pronation-abduction.
    Time Frame
    baseline
    Title
    X-ray examination
    Description
    To evaluate the healing degree of fracture
    Time Frame
    baseline and 3 months postoperatively
    Title
    MRI findings
    Description
    To evaluate ligament repair effects
    Time Frame
    baseline and 3 months postoperatively

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ankle fractures patients detected by X-ray Highly suspected ankle ligament injury History of obvious trauma Complete clinical data Irrespective of sex and age Sign the informed consent Exclusion Criteria: Cardiopulmonary function cannot tolerate anesthesia or surgery Open fractures of ankle joint Old fracture of the ankle joint
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Guobin Liu, Master
    Organizational Affiliation
    The First Affiliated Hospital of Hebei Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Classification of Ankle Injury Observed With X-ray Combined With Magnetic Resonance Imaging

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