Clinical trial NCT04009252: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Ankle Injuries
Fracture, Ankle
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Musculoskeletal Outcomes Data Evaluation and Management Scale (MODEMS) Expectations Questionnaire (expectations)
timeFrame: Change between pre-operative and 3 months after the patients operation
measure: Musculoskeletal Outcomes Data Evaluation and Management Scale (MODEMS) Expectations Questionnaire (satisfaction)
timeFrame: 3 months post-operative
Secondary outcomes:
measure: Visual Analogue Score (VAS) for Pain
timeFrame: 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.
measure: SF-12
timeFrame: Change between pre-operative to 6 months post-operative
measure: Foot and Ankle Ability Measure (FAAM)
timeFrame: Change between pre-operative to 6 months post-operative
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Investigator
name: Karl Lalonde, MD
role: PRINCIPAL_INVESTIGATOR
References: