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
About this trial
This is an interventional other trial for Ankle Injuries
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
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
NCT ID
NCT04009252
First Posted
June 12, 2019
Last Updated
July 3, 2019
Sponsor
Ottawa Hospital Research Institute
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
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Patient Education Using 3D Printed Model
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