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Operative Versus Non Operative Management Outcomes of Isolated Lateral Malleolar Weber B Ankle Fractures

Primary Purpose

Ankle Fractures

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ankle open reduction internal fixation
non operative management
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Fractures

Eligibility Criteria

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

Inclusion Criteria:

  • 18-65 years old
  • able to provide informed consent

Exclusion Criteria:

  • pregnancy
  • prisoners
  • psychiatric conditions that prevent ability to provide informed consent or present barriers to follow up
  • insulin dependent diabetics
  • patients with prior musculoskeletal issues affecting the same extremity
  • Patients cannot simultaneously be enrolled in any other studies.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    non operative control group

    non operative experimental group

    operative observational group

    Arm Description

    Patients with negative gravity stress (non-operative treatment/observational control group)

    Patients with positive gravity stress (medial clear space > 4 mm on initial injury pre-reduction x-rays, who undergo a reduction with closing of the medial clear space to <4mm. Plan for nonoperative treatment of all these patients with splint and subsequent walker boot.

    Patients with positive gravity stress (medial clear space > 4 mm) who undergo a reduction with closing of the medial clear space to <4mm who declined non-operative treatment but agree to be observed. These patients will undergo ORIF (Open Reduction and Internal Fixation) with plates and screws and function as a second observation group

    Outcomes

    Primary Outcome Measures

    radiographic outcome of ankle congruency
    measurement of medial clear space between medial malleolus and medial talar dome, measurement of tibiofibular overlap 1cm superior to the plafond, and measurement of superior clear space between the tibial plafond and the talar dome

    Secondary Outcome Measures

    functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) scoring system
    total score 0-100, with 100 being the maximum best score. (pain (0-40 points), function (0-50 points) and alignment (0-10 points)
    additional functional outcome by Short Form Survey (SF-36) Score scoring system
    0 to 100 range, 100 being the best; subscores Physical functioning (0-10), Role limitations due to physical health (0-4), Role limitations due to emotional problems (0-3), Energy/fatigue (0-4)Emotional well-being (0-5), Social functioning (0-2), Pain (0-2), General Health 0-5
    functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - Pain score
    none, mild occasional, moderate daily, severe and almost always present
    functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - function - activity limitations, support requirements
    no limitations and no support, no limitation of daily activities but limitation of recreational activities, limited daily and recreational activities, or severe limitation of daily and recreational activities
    functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - alignment
    good plantigrade, midfoot well aligned; fair plamtigrade, some degree of midfoot malalignment, poor with nonplantigrade foot, severe malalignment

    Full Information

    First Posted
    June 28, 2018
    Last Updated
    August 7, 2018
    Sponsor
    Cedars-Sinai Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03625154
    Brief Title
    Operative Versus Non Operative Management Outcomes of Isolated Lateral Malleolar Weber B Ankle Fractures
    Official Title
    Operative Versus Non Operative Management Outcomes of Isolated Lateral Malleolar Weber B Ankle Fractures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2018 (Anticipated)
    Primary Completion Date
    July 18, 2019 (Anticipated)
    Study Completion Date
    December 30, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cedars-Sinai Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The primary objective of this study is to determine the failure rate and difference in clinical outcomes between operative and non operative treatment of patients with Weber B lateral malleolus ankle fractures with medial clear space widening on gravity stress views. All patients presenting will be treated non operatively, and compared to an observational group comprised of patients with Weber B lateral malleolus ankle fractures without medial clear space widening, for which the standard of care is non operative management. Patients who decline non operative management and elect to undergo operative open reduction internal fixation with plates and screws will comprise an operative observational cohort. All patients will be followed for a total of 12 months from the time of injury. Clinical outcomes will be based on radiographic monitoring for ankle mortise congruency, as well as standardized SF-36 and AOFAS questionnaire scores.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    non operative control group
    Arm Type
    Active Comparator
    Arm Description
    Patients with negative gravity stress (non-operative treatment/observational control group)
    Arm Title
    non operative experimental group
    Arm Type
    Active Comparator
    Arm Description
    Patients with positive gravity stress (medial clear space > 4 mm on initial injury pre-reduction x-rays, who undergo a reduction with closing of the medial clear space to <4mm. Plan for nonoperative treatment of all these patients with splint and subsequent walker boot.
    Arm Title
    operative observational group
    Arm Type
    Active Comparator
    Arm Description
    Patients with positive gravity stress (medial clear space > 4 mm) who undergo a reduction with closing of the medial clear space to <4mm who declined non-operative treatment but agree to be observed. These patients will undergo ORIF (Open Reduction and Internal Fixation) with plates and screws and function as a second observation group
    Intervention Type
    Procedure
    Intervention Name(s)
    ankle open reduction internal fixation
    Intervention Description
    Open Reduction and Internal Fixation with plates and screws
    Intervention Type
    Other
    Intervention Name(s)
    non operative management
    Intervention Description
    closed reduction and splinting followed by progressive weight bearing
    Primary Outcome Measure Information:
    Title
    radiographic outcome of ankle congruency
    Description
    measurement of medial clear space between medial malleolus and medial talar dome, measurement of tibiofibular overlap 1cm superior to the plafond, and measurement of superior clear space between the tibial plafond and the talar dome
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) scoring system
    Description
    total score 0-100, with 100 being the maximum best score. (pain (0-40 points), function (0-50 points) and alignment (0-10 points)
    Time Frame
    1 year
    Title
    additional functional outcome by Short Form Survey (SF-36) Score scoring system
    Description
    0 to 100 range, 100 being the best; subscores Physical functioning (0-10), Role limitations due to physical health (0-4), Role limitations due to emotional problems (0-3), Energy/fatigue (0-4)Emotional well-being (0-5), Social functioning (0-2), Pain (0-2), General Health 0-5
    Time Frame
    1 year
    Title
    functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - Pain score
    Description
    none, mild occasional, moderate daily, severe and almost always present
    Time Frame
    1 year
    Title
    functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - function - activity limitations, support requirements
    Description
    no limitations and no support, no limitation of daily activities but limitation of recreational activities, limited daily and recreational activities, or severe limitation of daily and recreational activities
    Time Frame
    1 year
    Title
    functional outcome by American Orthopedic Foot and Ankle Score (AOFAS) - alignment
    Description
    good plantigrade, midfoot well aligned; fair plamtigrade, some degree of midfoot malalignment, poor with nonplantigrade foot, severe malalignment
    Time Frame
    1 year

    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: 18-65 years old able to provide informed consent Exclusion Criteria: pregnancy prisoners psychiatric conditions that prevent ability to provide informed consent or present barriers to follow up insulin dependent diabetics patients with prior musculoskeletal issues affecting the same extremity Patients cannot simultaneously be enrolled in any other studies.

    12. IPD Sharing Statement

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    Operative Versus Non Operative Management Outcomes of Isolated Lateral Malleolar Weber B Ankle Fractures

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