Ankle InjuriesNCT04009252
Patient Education Using 3D Printed Model
A study testing 3D Model Education in people with Ankle Injuries and Fracture, Ankle, run by Ottawa Hospital Research Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ankle Injuries, Fracture, Ankle
- What is being tested?
- 3D Model Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2019to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Multimodal Patient Education With a Personalized 3D Printed Model in Patients With Severe Periarticular Ankle Fractures
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
- Being tested
- 3D Model Education
- Medical subject headings
- Ankle Injuries, Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Model EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: 3D Model Education |
| Control Group | No intervention | The CT image will be shown to the patients along with teaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months post-operative
Secondary outcomes (3)
Visual Analogue Score (VAS) for Pain
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.
Measured: 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
Measure of quality of life
Measured: Change between pre-operative to 6 months post-operative
Foot and Ankle Ability Measure (FAAM)
Measure of ankle specific function
Measured: Change between pre-operative to 6 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Jul 2019 (estimated)
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karl Lalonde, MD, Principal investigator, Clinical Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009252
- Sponsor's protocol ID
- 2019
- Status last verified
- Jul 2019
- First submitted
- 12 Jun 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Multimodal Patient Education With a Personalized 3D Printed Model in Patients With Severe Periarticular Ankle Fractures
- ClinicalTrials.gov ID
- NCT04009252
- Acronym / sponsor ID
- 2019
- Conditions
- Ankle Injuries, Fracture, Ankle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: 3D Model Education3D 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) |
| Control Group | No intervention | –The CT image will be shown to the patients along with teaching |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D Model EducationA 3D model of the patients ankle fracture will be printed and used as a teaching tool to discuss long-term outcomes and potential complications. | Behavioural | Intervention Group |
Primary outcome
Musculoskeletal Outcomes Data Evaluation and Management Scale (MODEMS) Expectations Questionnaire (expectations)
Time frame: 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)
Time frame: 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.
3 secondary outcomes
Visual Analogue Score (VAS) for Pain
Time frame: 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
Time frame: Change between pre-operative to 6 months post-operative
Foot and Ankle Ability Measure (FAAM)
Time frame: Change between pre-operative to 6 months post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl Lalonde, MD principal investigator
Clinical Investigator
Questions about this trial
What is this clinical trial studying?
A study testing 3D Model Education in people with Ankle Injuries and Fracture, Ankle, run by Ottawa Hospital Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karl Lalonde, MD (613-737-8920, karllalonde@ottawahospital.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Musculoskeletal Outcomes Data Evaluation and Management Scale (MODEMS) Expectations Questionnaire (expectations) (time frame: Change between pre-operative and 3 months after the patients operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.