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The comparison of clinical and radiologic outcomes between the fibular nail versus standard open reduction and internal fixation for fixation of lateral malleolar fracture: Prospective randomized controlled study.

Status Approved

  • First Submitted Date

    2020/02/21

  • Registered Date

    2020/02/25

  • Last Updated Date

    2020/02/21

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0004768
    Unique Protocol ID WKUH 201910004005
    Public/Brief Title The comparison of outcomes between the fibular nail versus open reduction and internal fixation for lateral malleolar fracture
    Scientific Title The comparison of clinical and radiologic outcomes between the fibular nail versus standard open reduction and internal fixation for fixation of lateral malleolar fracture: Prospective randomized controlled study.
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number WKUH 201910004005
    Approval Date 2020-02-05
    Institutional Review Board Name Wonkwang University Hospital Institutional Review Board
    Institutional Review Board Address 895, Muwang-ro, Iksan-si, Jeollabuk-do
    Institutional Review Board Telephone 063-859-2232
    Data Monitoring Committee
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Sung Hyun Lee
    Title Assisted Professor
    Telephone +82-63-268-1360
    Affiliation Wonkwang University Hospital
    Address Wonkwang University Hospital Institutional Review Board
    Contact Person for Public Queries
    Name Sung Hyun Lee
    Title Assisted Professor
    Telephone +82-63-268-1360
    Affiliation Wonkwang University Hospital
    Address Wonkwang University Hospital Institutional Review Board
    Contact Person for Updating Information
    Name Sung Hyun Lee
    Title Assisted Professor
    Telephone +82-63-268-1360
    Affiliation Wonkwang University Hospital
    Address Wonkwang University Hospital Institutional Review Board
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2020-02-06 Actual
    Target Number of Participant 60
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Wonkwang University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2020-02-06 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Wonkwang University Hospital
    Organization Type Medical Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Wonkwang University Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Ankle fracture was first introduced by Sir Percival Pott in 1768 and is one of the most commonly observed bone damages. The prevalence of ankle fractures has also increased as the number of osteoporosis patients has increased as the age of aging. The most commonly accepted fracture classification systems are the "Danis-Weber" system and the "Lauge-Hansen" system. Both classification systems have classified and defined fractures to manage these damages on the basis of stability related to the degree of dislocation, whether or not the medial part is damaged and whether the bone has been displaced. Fracture treatment aims to reduction displaced fractures, maintain anatomical alignment on radiological examinations, and achieve bone union.
    The open reduction and internal fixation is generally fixed through metal plates and screws in accordance with AO principle. In unstable ankle fractures, open reduction and internal fixation through plate and screw are common, but since the 1960s, plate development has been minimal. The fixation with plate and screw is associated with a number of complications. Extensive incisions and exfoliation of soft tissues over the bones are essential for exposing fractures, leaving vulnerable wounds. Wound dehiscence and infections are reported up to 25%, especially in people with diabetes and neuropathy or in older people. The cost of treating these complications can be more expensive and the long-term follow-up results are usually poor. Thin soft tissue on the plate may delay wound healing and may eventually require additional plate removal in 50% of patients whose wounds are not healed. Placing a metal plate behind the fibula can reduce wound-related complications but can cause irritation of the peroneal tendon. Mechanical failure of fixation occurs up to 14%, especially in the presence of osteoporosis, and the pull-out is common with loose screws. A study of open reduction and internal fixation in 1,822 patients with ankle fractures showed unsatisfactory results in functional, clinical and radiological follow-up in one-fifth patients. 
    Fibula intramedullary nailing has been developed by Bugler et al., and fibula intramedullary nailing can avoid the above complications and thus improve clinical and radiological results. Representative features include reduction of incision size and axial holding force of the metal. According to a Kadeba study, the fibula nail can withstand higher loads than conventional metal plates and screws. However, the number of screws to be fixed is relatively small compared to the metal plate, so the fixing force may be weak for a particular bone fragment according to the fracture pattern and the number of screws that bear the load applied to the weight load is small, so the stress transmitted to each screw is exceeded. Screw loosening and pull-out are known complications. According to a study of 50 patients who underwent intramedullary nailing, a locking screw was released in 10% of the patients and an additional screw was removed. After that, one patient who had lost anatomical reduction was reoperated with internal fixation using a plate after removal of the nail. 
    In the future, further studies on the two representative surgical methods should be developed to become more effective treatments.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Single
    Blinded Subject Subject, Outcome Accessor
    Allocation RCT
    Intervention Type /Procedure/Surgery  
    Intervention Description
    We performed  an open reduction and internal fixation or a closed reduction and intramedullart nail fixation for lateral malleolus fractures.
    Number of Arms 2
    Arm 1

    Arm Label

    Open reduction and internal fixation group

    Target Number of Participant

    30

    Arm Type

    Experimental

    Arm Description

    We performed an open reduction and internal fixation for lateral malleolar fracture.
    Arm 2

    Arm Label

    intramedullart nail fixation group

    Target Number of Participant

    30

    Arm Type

    Experimental

    Arm Description

    We performed a closed reduction and intramedullart nail fixation for lateral malleolus fractures.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (S00-T98)Injury, poisoning and certain other consequences of external causes 
       (S82.880)Fracture of other parts of lower leg, closed 

    ankle fracture
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    18Year~No Limit

    Description

    (1) patients with displaced lateral malleolar fractures of ankle joint
    (2) Patients who agreed to treatment method and postoperative examination
    (3) Patients who can have CT scan before and after surgery
    (4) Patients who are expected to be able to follow up for more than one year
    (5) Patients who agreed to the agreement
    Exclusion Criteria
    (1) open ankle fracture
    (2) past fractures in the affected foot and ankle joint
    (3) Past surgical history of affected foot and ankle
    (4) alteration of ankle alignment due to arthritis, congenital diseases, etc.
    (5) History of other musculoskeletal and nervous system diseases
    Healthy Volunteers
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    Foot and Ankle Outcome Score
    Timepoint
    Postoperative 3months, 6months, 1year and yearly
    Secondary Outcome(s) 1
    Outcome
    Presence of posttraumatic arthritis
    Timepoint
    Postoperative 3months, 6months, 1year and yearly
    Secondary Outcome(s) 2
    Outcome
    Visual analogue scale
    Timepoint
    Postoperative 3months, 6months, 1year and yearly
    Secondary Outcome(s) 3
    Outcome
    American Orthopedic foot and ankle score
    Timepoint
    Postoperative 3months, 6months, 1year and yearly
    Secondary Outcome(s) 4
    Outcome
    Karlsson Score
    Timepoint
    Postoperative 3months, 6months, 1year and yearly
    Secondary Outcome(s) 5
    Outcome
    Tegner Activity Scales
    Timepoint
    Postoperative 3months, 6months, 1year and yearly
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Yes
    Time of Sharing 2023. 12
    Way of Sharing Available on Request
    (kensin06@hanmail.net)
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