NCT04430270

Brief Summary

Background: Three-dimensional (3D) patient-specific anatomical model guidance is a reliable tool in obtaining accurate bony cuts, precise implant placement, and satisfactory surgical results. These can enhance surgeon's understanding of their patients' patho-anatomy also helping in precise preoperative planning. So, the hypothesis of this study is that, in the training of orthopaedic residency, 3D printed models reflecting the patient's individual process provide a a foresight and a perception of the bone pathologies and osseous relationships before orthopaedic intervention. Methods: In this study, the investigators displayed our experience of creating realistic 3D models in orthopaedic surgical case scenarios to evaluate the perceptions of fellows in orthopaedic surgeon training. The investigators based our study on the comparision of the perception of residents who were presented with four-step carousel consisting of different scenarios as trauma (calcaneal fracture), deformity (hallux valgus), tumoral mass (sacral chondrosarcoma), and reconstructive procedure (multidisciplinary cancer surgery). The X-ray images, computed tomography (CT), and 1:1 solid models of the cases were included in each step. The orthopaedic residents were asked to compare their perception level of the actual scenarios in evaluating the effectiveness of each tool in terms of perceiving the orthopaedic problem, understanding the bone pathology, classification of diagnosis and preoperative data planning.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2020

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

5 months

First QC Date

June 3, 2020

Last Update Submit

June 11, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Creating life-size patient-specific orthopaedic surgery cases model

    A multi-item survey was prepared to assess fellow's perception of residency training. The survey utilized by our group, addressed the issues in understanding patient bone anatomy, seeing osseous pathology, independent decision-making, differential pathological diagnosis, plan on key surgical steps, and preparation for unexpected events. Residents who completed their examination in the stations evaluated each imaging method and answered the questions on a scale of 10. Scoring in the scale (1 - 10) describes 0 = very low and 10= the highest level.Descriptive statistics and Friedman test were used for comparison analysis. Data were analyzed using IBM SPSS Statistics, version 24 (IBM Corp., Armonk, NY).

    The research took 12 months, 05.02.2020, Each participant spends 45 minutes for the survey.

Study Arms (1)

Comparison of Perceptions of X-ray, CT and 3D Model

The study group consisted of 11 orthopaedic residents of University Hospital. Selection criteria for the 4 cases was the involved patients who required orthopaedic surgery. 4 cases for orthopaedic procedures were determined with the consensus of experts. As data collection tool was used to evaluate the perceptions of each of these imaging methods in terms of their usefulness in seeing the surgical problem, their efficiency in differential diagnosis and presurgical planning. CT images were converted into in the 3D model was prepared. The survey utilized by our group, addressed the issues in understanding bone anatomy, seeing pathology, and preparation for unexpected events. A multi-item survey was prepared to assess fellow's perception of residency training. Residents who completed their examination in the stations answered the questions on a scale of 10. Descriptive statistics and Friedman test were used for comparison analysis using IBM SPSS Statistics, version 24.

Behavioral: Survey

Interventions

SurveyBEHAVIORAL

Sequential Assignment

Comparison of Perceptions of X-ray, CT and 3D Model

Eligibility Criteria

Age24 Years - 30 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsAll assistants are men.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study group consisted of 11 orthopaedic residents of University Hospital.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University, Faculty of Medicine

Izmir, Bornova, TR-35100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Yelda PINAR, Prof. Dr.

    Faculty of Medicine, Ege University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr, Senior investigator

Study Record Dates

First Submitted

June 3, 2020

First Posted

June 12, 2020

Study Start

January 10, 2019

Primary Completion

June 10, 2019

Study Completion

May 10, 2020

Last Updated

June 16, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share

In this study, we displayed our experience of creating realistic 3D models in orthopaedic surgical case scenarios to evaluate the perceptions of fellows in orthopaedic surgeon training. We based our study on the comparision of the perception of residents who were presented with four-step carousel consisting of different scenarios as trauma (calcaneal fracture), deformity (hallux valgus), tumoral mass (sacral chondrosarcoma), and reconstructive procedure (multidisciplinary cancer surgery). The X-ray images, computed tomography (CT), and 1:1 solid models of the cases were included in each step. The orthopaedic residents were asked to compare their perception level of the actual scenarios in evaluating the effectiveness of each tool in terms of perceiving the orthopaedic problem, understanding the bone pathology, classification of diagnosis and preoperative data planning.

Shared Documents
STUDY PROTOCOL
Time Frame
Aim of this study, is also to show that the models can assist in the training of novice surgeons in complicated areas like trauma, deformity and cancer surgery. Yet another aim of the present study is to assess whether the 3D model could be more informative than standard X-ray and CT image visualizations in predicting the real outcome of the orthopaedic surgery cases.
Access Criteria
With the help of 3D printing technology, in this study, it is possible to implement and evaluate a well-structured real patient scenario setup for orthopaedic and traumatic surgery training. The orthopaedic intervention based on scenarios for residency is more original since there is no prior study including both model building and the evaluation of the perception created by the model. It can be used to improve the understanding of pathoanatomical changes of bone disease and to guide surgical strategy.

Locations