The aim of this study was to determine the use of 3D printing technology in bone modeling along with the usual CT scan imaging process. To compare the consequences of pelvic surgery with the presence or absence of 3D printing technology in bone molding.
Design
This study was a parallel randomized controlled trial study design. The sample size of the study is 60 patients that will be assigned to intervention and control groups using simple randomization method.
Settings and conduct
Patient outcomes will be assessed at 2, 4, and 8 weeks after imaging using surgery. This study will be performed in the orthopedic ward of Rasoul Akram hospital of Iran University of Medical Sciences. Because it is clear that the intervention processes are aware for both patients and physicians, blinding is not applicable in this study and also the outcomes are measured objectively and with the help of imaging, the bias caused by patient evaluation is minimized.
Participants/Inclusion and exclusion criteria
The main inclusion criteria are confirmation of pelvic fractures and age 18 to 80 years and non-inclusion criteria include pathological fractures, bone tumors and history of pelvic surgery.
Intervention groups
All patients undergoing pelvic surgery in this study will undergo CT scan imaging and 3D printing technology which is a routine process. Only for the intervention group, bone modeling will be done with 3D printing technology, but for the comparison group, the molding is routine.
Main outcome variables
Duration of surgery, accuracy of reduction in surgery, bleeding, complications of surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200620047852N2
Registration date:2021-11-30, 1400/09/09
Registration timing:registered_while_recruiting
Last update:2021-11-30, 1400/09/09
Update count:0
Registration date
2021-11-30, 1400/09/09
Registrant information
Name
Shayan Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2236 3375
Email address
amiri.shayan23@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-21, 1400/08/30
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the role of 3D printing technology in modeling pelvic fracture surgery
Public title
3D-printing technology In fractures surgery
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of pelvic fracture by an orthopedic surgeon and imaging
Age between 18 to 80
Patients consent to participate in the study
Exclusion criteria:
Pathological fractures
Bone tumors
Patients who have high underlying diseases due to the type of surgical fracture
History of pelvic surgery
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
After the participants were selected to study, we will use simple randomization method to assign participants to the groups for received intervention and comparison. The randomization process will be performed using Random Allocation software, and since this study consists of two groups, the allocation outputs of the participants will be identified by A and B so the assign of each patient in each group is unpredictable to other members of the research team. We will notify for the team manager after selecting each patient and they will determine the type of group each person according to the software output.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-11-11, 1399/08/21
Ethics committee reference number
IR.IUMS.REC.1399.786
Health conditions studied
1
Description of health condition studied
pelvic fracture
ICD-10 code
S32.8
ICD-10 code description
Fracture of other parts of pelvis
Primary outcomes
1
Description
Reduction accuracy
Timepoint
Weeks 2, 4 and 8 after surgery
Method of measurement
AP Imaging and Judet technique
2
Description
Complications
Timepoint
Weeks 2, 4 and 8 after surgery
Method of measurement
Infection, neurovascular injury, need for reoperation, limb length change, thromboembolism, chronic pain
Secondary outcomes
1
Description
Bleeding
Timepoint
ِDuring the surgery
Method of measurement
CC
2
Description
Duration of surgery
Timepoint
Duration of surgery
Method of measurement
Operating time in minutes
Intervention groups
1
Description
Intervention group: Bone mdeling will be performed for all patients in this group with 3D printing technology
Category
Diagnosis
2
Description
Control group:Bone modeling will be performed routinely for all patients in this group.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Ali Yeganeh
Street address
Rasoul Akram hospital, Niyayesh St, Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
1465613131
Phone
+98 21 6435 1234
Email
yeganeh.a@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein keyvani
Street address
Iran University of Medical Sciences, Shahid Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8687 2555
Email
tavakoli.m@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Yeganeh
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Rasoul Akram hospital, Niyayesh St, Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 3344 2345
Email
yeganeh.a@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Yeganeh
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Rasoul Akram hospital, Niyayesh St, Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 2255 6498
Email
yeganeh.a@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shayan Amiri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Rasoul Akram hospital, Niyayesh St, Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 2222 5546
Email
amiri.shayan23@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Finding of the study, demographic data of participants in the study, in addition to descriptive and analytical analysis of variables
When the data will become available and for how long
Availability six months after the end of study
To whom data/document is available
Orthopedics
Under which criteria data/document could be used
Anyone who has a request for information about the results of this research
From where data/document is obtainable
Iran University of Medical Sciences
What processes are involved for a request to access data/document
By referring to the central library and clinical trial center in Iran University of Medical Sciences can access to the documents of participants, data and results.