Patient Education Using 3D Printed Model

Not Applicable

• Conditions: Fracture, Ankle; Ankle Injuries
• Interventions: Behavioral: 3D Model Education

• Registration Number: NCT04009252
• Lead Sponsor: Ottawa Hospital Research Institute

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 available

Study Timeline

• Study First Submitted: 2019-06-12
• Status Verified: 2019-07
• Study Start: 2019-07-01
• Study First Submitted QC: 2019-07-03
• Last Update Submitted: 2019-07-03
• Study First Posted: 2019-07-05
• Last Update Posted: 2019-07-05
• Primary Completion: 2020-07-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	3D Model Education	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)

Primary Outcome Measures

Name	Time	Method
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.
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

Name	Time	Method
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.
Foot and Ankle Ability Measure (FAAM)	Change between pre-operative to 6 months post-operative	Measure of ankle specific function
SF-12	Change between pre-operative to 6 months post-operative	Measure of quality of life