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出境医 / 临床实验 / Patient Education Using 3D Printed Model

Patient Education Using 3D Printed Model

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.

Condition or disease Intervention/treatment Phase
Ankle Injuries Fracture, Ankle Behavioral: 3D Model Education Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of Multimodal Patient Education With a Personalized 3D Printed Model in Patients With Severe Periarticular Ankle Fractures
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 1, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Intervention Group
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)
 Behavioral: 3D Model Education
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.
No Intervention: Control Group
The CT image will be shown to the patients along with teaching
Outcome Measures
Primary Outcome Measures :
  1. Musculoskeletal Outcomes Data Evaluation and Management Scale (MODEMS) Expectations Questionnaire (expectations) [ Time Frame: Change between pre-operative and 3 months after the patients operation ]
    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.

  2. Musculoskeletal Outcomes Data Evaluation and Management Scale (MODEMS) Expectations Questionnaire (satisfaction) [ Time Frame: 3 months post-operative ]
    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 :
  1. Visual Analogue Score (VAS) for 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. ]
    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.

  2. SF-12 [ Time Frame: Change between pre-operative to 6 months post-operative ]
    Measure of quality of life

  3. Foot and Ankle Ability Measure (FAAM) [ Time Frame: Change between pre-operative to 6 months post-operative ]
    Measure of ankle specific function


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Karl Lalonde, MD 613-737-8920 karllalonde@ottawahospital.on.ca

Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Karl Lalonde, MD Clinical Investigator
Tracking Information
First Submitted Date  ICMJE June 12, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date July 5, 2019
Estimated Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • Musculoskeletal Outcomes Data Evaluation and Management Scale (MODEMS) Expectations Questionnaire (expectations) [ Time Frame: Change between pre-operative and 3 months after the patients operation ]
    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) [ Time Frame: 3 months post-operative ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • Visual Analogue Score (VAS) for 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. ]
    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 [ Time Frame: Change between pre-operative to 6 months post-operative ]
    Measure of quality of life
  • Foot and Ankle Ability Measure (FAAM) [ Time Frame: Change between pre-operative to 6 months post-operative ]
    Measure of ankle specific function
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Patient Education Using 3D Printed Model
Official Title  ICMJE Effect of Multimodal Patient Education With a Personalized 3D Printed Model in Patients With Severe Periarticular Ankle Fractures
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Ankle Injuries
  • Fracture, Ankle
Intervention  ICMJE Behavioral: 3D Model Education
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.
Study Arms  ICMJE
  • Experimental: Intervention Group
    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)
    Intervention: Behavioral: 3D Model Education
  • No Intervention: Control Group
    The CT image will be shown to the patients along with teaching
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 3, 2019) 		28
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2020
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karl Lalonde, MD 613-737-8920 karllalonde@ottawahospital.on.ca
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04009252
Other Study ID Numbers  ICMJE 2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ottawa Hospital Research Institute
Study Sponsor  ICMJE Ottawa Hospital Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karl Lalonde, MD Clinical Investigator
PRS Account Ottawa Hospital Research Institute
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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