- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06061003
3D Resin Printed Fracture Models for Anatomy Education
Can High Resolution 3D Resin Printed Models be Used in Clinical Anatomy Education for Fracture Rehabilitation
Study Overview
Status
Detailed Description
Over the past decade, 3D printing has become increasingly accessible and cost-effective, offering systems and materials suitable for home use. 3D printing is a technology that streamlines production by translating computer-generated models into physical objects, layer by layer. In comparison to other tissue engineering and rapid prototyping methods, 3D printing boasts numerous advantages, such as exceptional precision, rapid production, cost-effectiveness, and seamless integration. Utilizing 3D models can significantly enhance the comprehension of intricate structures for medical professionals and students alike. Common materials used in 3D printing include robust nylon, aluminum, gypsum, textile components, polylactic acid, and resin. Among these, photosensitive resin stands out, as it enables the creation of higher-quality, more intricate structures that closely resemble real tissues, offering a smoother finish devoid of visible raw material textures.
This study's primary objective was to assess the suitability of tissues produced by a 3D resin printer in anatomy education, with the aim of enhancing hands-on training through direct manipulation of fractured bone models.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Muhammed NUR OGUN, PhD
- Phone Number: +905072329466
- Email: drmogun@gmail.com
Study Locations
-
-
Merkez
-
Bolu, Merkez, Turkey, 14100
- Recruiting
- Abant Izzet Baysal University
-
Contact:
- Ramazan Kurul, Ph.D
- Phone Number: +905436414731
- Email: ramazankurul2@hotmail.com
-
Contact:
- Muhammed Nur ÖĞÜN, M.D
- Phone Number: +905072329466
- Email: dr.mogun@gmail.com
-
Principal Investigator:
- Ramazan Kurul, Ph.D
-
Sub-Investigator:
- Mustafa Fatih Yaşar, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- having stereopsis above 40 arc/seconds according to the Titmus Stereopsis Test
Exclusion Criteria:
- having partial or total vision loss
- having a history of traumatic injury to the upper extremities within the last six months
- having used wrist anatomy models in virtual or real environments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Fractured Model Group
All participants will receive 60 minutes training on anatomy and pathophysiology of theoric wrist fractures.
After lecture completed, the Fractured Model Group will engage in a 2-hours hands-on practical session in the laboratory, working with wrist fracture models.
|
Participants will undergo a 2-hour training session, consisting of 60 minutes of theory and 60 minutes of practice.
The theoretical lesson, supported by 2D images illustrating wrist anatomy, types of fractures, and rehabilitation based on fracture type, will be simultaneously delivered to both groups.
Following this, the practical group will receive a 60-minute hands-on session using 3D-printed digital models of radius and ulna fractures.
These training sessions will be scheduled in the morning hours, on a day when students have no other classes between 9 am and 12 pm, to minimize mental fatigue and exhaustion.
In the practical session, anatomical structures, their relationships, and arrangements will be demonstrated to the practice group using a model of a fractured wrist.
|
|
Other: Standard Anatomic Model Group
All participants will receive 60 minutes training on anatomy and pathophysiology of theoric wrist fractures.After lecture completed, the Standard Anatomic Model Group will engage in a 2-hours hands-on practical session in the laboratory, working with standard anatomical wrist models.
|
Participants will undergo a 2-hour training session, consisting of 60 minutes of theory and 60 minutes of practice.
The theoretical lesson, supported by 2D images illustrating wrist anatomy, types of fractures, and rehabilitation based on fracture type, will be simultaneously delivered to both groups.
Following this, the practical group will receive a 60-minute hands-on session using 3D-printed digital models of radius and ulna fractures.
These training sessions will be scheduled in the morning hours, on a day when students have no other classes between 9 am and 12 pm, to minimize mental fatigue and exhaustion.
The control group will receive the same practical session using a standard anatomical model.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Test
Time Frame: one hour
|
A 25-question multiple choice questions test will be employed to assess students' anatomical knowledge and their decision-making capabilities for the rehabilitation program.
The test will be prepared according to Bloom's taxonomy and will consist of both multiple-choice and open-ended questions.
Total test time wil lbe 60 minutes and scores will be recorded as percentages.
|
one hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Academic Motivation
Time Frame: one hour
|
Academic Motivation Scale test taking motivation questionnaire will be used to assess participants' motivations.
This scale, consisting of 22 questions and 7 subscales, evaluates amotivation, as well as internal and external motivation.
|
one hour
|
|
Test Anxiety Inventory
Time Frame: one hour
|
To examine whether there is a change in the level of anxiety experienced by students during the exam, a 5-question short version of Test Anxiety Inventory will be used.
The test includes sections related to ease, comfort associated with learning, and alignment of exam questions with the course.
|
one hour
|
|
Enjoyment and Ease of Use Assessment
Time Frame: one hour
|
Participants will fill out a feedback questionnaire regarding the learning instruments using visual analogue scale.
|
one hour
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ramazan Kurul, Abant Izzet Baysal University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIBU-FTR-RK-08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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