Patient Education Using 3D Printed Model

NCT04009252 | Unknown

• 1 other identifier: 2019
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ankle Injuries; Fracture, Ankle

Outcome Measures

Primary Outcomes (2)

• 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.

  Change between pre-operative and 3 months after the patients operation

• 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.

  3 months post-operative

Secondary Outcomes (3)

• 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.

• SF-12

  Change between pre-operative to 6 months post-operative

• Foot and Ankle Ability Measure (FAAM)

  Change between pre-operative to 6 months post-operative

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

The CT image will be shown to the patients along with teaching

Interventions

3D Model Education BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

MeSH Terms

Conditions

Ankle Injuries; Ankle Fractures

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Karl Lalonde, MD

  Clinical Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karl Lalonde, MD

CONTACT

613-737-8920; karllalonde@ottawahospital.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: July 5, 2019
• Study Start: July 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 5, 2019

Record last verified: 2019-07