Skip to content

Patient Education Using 3D Printed Model

Effect of Multimodal Patient Education With a Personalized 3D Printed Model in Patients With Severe Periarticular Ankle Fractures

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04009252
Enrollment
28
Registered
2019-07-05
Start date
2019-07-01
Completion date
2020-12-01
Last updated
2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Injuries, Fracture, Ankle

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.

Interventions

BEHAVIORAL3D 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.

Sponsors

Ottawa Hospital Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Musculoskeletal Outcomes Data Evaluation and Management Scale (MODEMS) Expectations Questionnaire (expectations)Change between pre-operative and 3 months after the patients operationThe 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-operativeThe 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

MeasureTime frameDescription
Visual Analogue Score (VAS) for PainChange 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-12Change between pre-operative to 6 months post-operativeMeasure of quality of life
Foot and Ankle Ability Measure (FAAM)Change between pre-operative to 6 months post-operativeMeasure of ankle specific function

Contacts

Primary ContactKarl Lalonde, MD
karllalonde@ottawahospital.on.ca613-737-8920

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026