Patient Education Using 3D Printed Model

Sponsor
Ottawa Hospital Research Institute (Other)
Overall Status
Unknown status
CT.gov ID
NCT04009252
Collaborator
(none)
28
2
17.1

Study Details

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
  • Behavioral: 3D Model Education
N/A

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Jul 1, 2019
Anticipated Primary Completion Date :
Jul 1, 2020
Anticipated Study Completion Date :
Dec 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) [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) [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 [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 [Change between pre-operative to 6 months post-operative]

    Measure of quality of life

  3. Foot and Ankle Ability Measure (FAAM) [Change between pre-operative to 6 months post-operative]

    Measure of ankle specific function

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Ottawa Hospital Research Institute

Investigators

  • Principal Investigator: Karl Lalonde, MD, Clinical Investigator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT04009252
Other Study ID Numbers:
  • 2019
First Posted:
Jul 5, 2019
Last Update Posted:
Jul 5, 2019
Last Verified:
Jul 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 5, 2019