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Patient Education Using 3D Printed Model

Primary Purpose

Ankle Injuries, Fracture, Ankle

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
3D Model Education
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ankle Injuries

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • periarticular injury involving the plafond, calcaneus or talus that requires open reduction and internal fixation
  • Patient must have a completed CT scan as part of their pre-operative planning protocol

Exclusion Criteria:

  • open fracture
  • patient with known psychiatric history (depression, borderline personality disorder, bipolar etc)
  • prior fracture fixation of the same ankle or foot
  • diabetic neuropathy/Charcot foot
  • dementia or other cognitive comorbidities (ie stroke etc)
  • no primary address
  • patient who were not independent mobilizers prior to injury

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention Group

    Control Group

    Arm Description

    3D model to be printed and used as teaching tool to discuss injury with patient as well as its associated long-term outcomes and potential complications. The operative plan will also be reviewed with the patient using the model as well as post-operative course (ie rehabilitation)

    The CT image will be shown to the patients along with teaching

    Outcomes

    Primary Outcome Measures

    Musculoskeletal Outcomes Data Evaluation and Management Scale (MODEMS) Expectations Questionnaire (expectations)
    The expectations of a patient in regards to their ankle surgery, this questionnaire is on a Likert scale from 1 to 5 with 1 indicating a worse score.
    Musculoskeletal Outcomes Data Evaluation and Management Scale (MODEMS) Expectations Questionnaire (satisfaction)
    The satisfaction of a patient in regards to their ankle surgery, this questionnaire is on a Likert scale from 1 to 5 with 1 indicating a worse score.

    Secondary Outcome Measures

    Visual Analogue Score (VAS) for Pain
    Patient will indicate on a scale from 1 to 10 cm on how bad they feel their pain is with a score of 1 indicating no pain and 10 indicating extreme pain.
    SF-12
    Measure of quality of life
    Foot and Ankle Ability Measure (FAAM)
    Measure of ankle specific function

    Full Information

    First Posted
    June 12, 2019
    Last Updated
    July 3, 2019
    Sponsor
    Ottawa Hospital Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04009252
    Brief Title
    Patient Education Using 3D Printed Model
    Official Title
    Effect of Multimodal Patient Education With a Personalized 3D Printed Model in Patients With Severe Periarticular Ankle Fractures
    Study Type
    Interventional

    2. Study Status

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

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ottawa Hospital Research Institute

    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
    Complex high energy fractures of the lower extremity are life changing injuries and are known to be associated with poor functional outcome post operatively. The list of potential post-operative complications associated with these injuries is long, and the worst of these fractures can even be limb threatening. One of the most difficult and prevalent post-operative issues this patient population faces is chronic pain and its association to opioid addiction, which is currently an epidemic across North America. These individuals not only present with physical insult but psychological trauma as well, which also greatly affects these patients post-operatively. Properly educating the patient about their injury and the process that they will embark on can greatly empower the patient as they begin their journey of rehabilitation. This process can hopefully mute or silence some of these modifiable risk factors predisposing patients to poor functional outcomes and chronic pain. The investigators also hope to help them initiate/develop coping strategies to better overcome the many obstacles these patients face and to do so using 3D printing. 3D printed models have not only been demonstrated to be valuable in orthopaedics, when it comes to educating patients about their disease and associated interventions, but many other specialties as well; such as: cardiac surgery, urology, and general surgery. Literature suggest that often little is understood or retained by the patient following a patient consent with regards to their injury, potential complications, interventions to be undertaken, as well as the rehabilitation process to follow. By providing the patient with a 3D printed model of their fracture while educating them pre-/post-operatively, the investigators hope they will better understand the aforementioned, often forgotten points, indirectly yielding better overall patient satisfaction, patient outcomes and pain scores.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    28 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    3D model to be printed and used as teaching tool to discuss injury with patient as well as its associated long-term outcomes and potential complications. The operative plan will also be reviewed with the patient using the model as well as post-operative course (ie rehabilitation)
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    The CT image will be shown to the patients along with teaching
    Intervention Type
    Behavioral
    Intervention Name(s)
    3D Model Education
    Intervention Description
    A 3D model of the patients ankle fracture will be printed and used as a teaching tool to discuss long-term outcomes and potential complications.
    Primary Outcome Measure Information:
    Title
    Musculoskeletal Outcomes Data Evaluation and Management Scale (MODEMS) Expectations Questionnaire (expectations)
    Description
    The expectations of a patient in regards to their ankle surgery, this questionnaire is on a Likert scale from 1 to 5 with 1 indicating a worse score.
    Time Frame
    Change between pre-operative and 3 months after the patients operation
    Title
    Musculoskeletal Outcomes Data Evaluation and Management Scale (MODEMS) Expectations Questionnaire (satisfaction)
    Description
    The satisfaction of a patient in regards to their ankle surgery, this questionnaire is on a Likert scale from 1 to 5 with 1 indicating a worse score.
    Time Frame
    3 months post-operative
    Secondary Outcome Measure Information:
    Title
    Visual Analogue Score (VAS) for Pain
    Description
    Patient will indicate on a scale from 1 to 10 cm on how bad they feel their pain is with a score of 1 indicating no pain and 10 indicating extreme pain.
    Time Frame
    Change between pre-operative to 6 months post-operative, this questionnaire is on a Likert scale from 1 to 5 with 1 indicating a worse score.
    Title
    SF-12
    Description
    Measure of quality of life
    Time Frame
    Change between pre-operative to 6 months post-operative
    Title
    Foot and Ankle Ability Measure (FAAM)
    Description
    Measure of ankle specific function
    Time Frame
    Change between pre-operative to 6 months post-operative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: periarticular injury involving the plafond, calcaneus or talus that requires open reduction and internal fixation Patient must have a completed CT scan as part of their pre-operative planning protocol Exclusion Criteria: open fracture patient with known psychiatric history (depression, borderline personality disorder, bipolar etc) prior fracture fixation of the same ankle or foot diabetic neuropathy/Charcot foot dementia or other cognitive comorbidities (ie stroke etc) no primary address patient who were not independent mobilizers prior to injury
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Karl Lalonde, MD
    Phone
    613-737-8920
    Email
    karllalonde@ottawahospital.on.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Karl Lalonde, MD
    Organizational Affiliation
    Clinical Investigator
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Patient Education Using 3D Printed Model

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