Patient Education Using 3D Printed Model

NCT ID: NCT04009252

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2020-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention Group

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)

Group Type: EXPERIMENTAL

3D Model Education

Intervention Type: 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.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

3D 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karl Lalonde, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Investigator

Central Contacts

Karl Lalonde, MD

Role: CONTACT

karllalonde@ottawahospital.on.ca

613-737-8920

Other Identifiers

2019

Identifier Type: -

Identifier Source: org_study_id