Study aim is the comparison of the effect of bone increment technique and osteotomy on frontoorbital deformity in patients with non-syndromic craniosynostosis.
Design
Two arm parallel group, randomized, controlled clinical trial on 10 patients.
Simple randomization was used.
Settings and conduct
This study will be conducted in 2022 and in Imam Hossein Children Hospital in Isfahan. In this study, blinding was not done, and patients were randomly divided into intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Patients with non-syndromic simple coronal suture craniosynostosis,
2. Patients with non-syndromic simple metopic suture craniosynostosis
Exclusion criteria:
1. Lack of informed consent of parents,
2. Presence of any underlying disease that is a contraindication for surgery,
3. Previous history of skull surgery
Intervention groups
Intervention group: The bone increment technique without common complications will be used.
Control group: The classic osteotomy method with known complications will be used.
Main outcome variables
Correction of deformity of the forehead and orbit
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220816055722N1
Registration date:2022-12-03, 1401/09/12
Registration timing:registered_while_recruiting
Last update:2022-12-03, 1401/09/12
Update count:0
Registration date
2022-12-03, 1401/09/12
Registrant information
Name
Ata Mahdkhah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3662 4589
Email address
amahdkhah@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-06, 1401/06/15
Expected recruitment end date
2022-12-06, 1401/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of bone increment technique and osteotomy on frontoorbital deformity in patients with non-syndromic craniosynostosis
Public title
Correction of forehead and orbit deformities in patients with non-syndromic craniosynostosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with non-syndromic simple coronal suture craniosynostosis
Patients with non-syndromic simple metopic suture craniosynostosis
Exclusion criteria:
Lack of informed consent of parents
The presence of any underlying disease that is a contraindication for surgery
Previous history of skull surgery
Age
From 3 months old to 3 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
We used simple, individual randomization and random number table randomization.
Random number table is a set of numbers that are generated without a specific pattern or order and in a completely random manner and become a table.
First, we selected 10 two-digit numbers according to the number of people studied, and among these numbers, 5 numbers were randomly selected from the table and were used as the intervention group. The rest numbers were considered as the control group.
In order to use the table of random numbers, we first predetermined the table to read the numbers, then we considered the numbers for different groups, then we touched one of the numbers and moved in one of the predefined directions and recorded the numbers.
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 Medical Faculty of Isfahan University of Medical Sciences
Street address
No. 4, Isfahan University of Medical Sciences, Hezar Jerib Ave; Telephone:03137923084
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-07-17, 1401/04/26
Ethics committee reference number
IR.MUI.MED.REC.1401.160
Health conditions studied
1
Description of health condition studied
Craniosynostosis
ICD-10 code
Q75.0
ICD-10 code description
Craniosynostosis
Primary outcomes
1
Description
Correction of deformity of the forehead and orbit
Timepoint
Before intervention and three months after intervention
Method of measurement
CT Scan
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Bone increment technique will be used in 5 patients. This method is an innovative method to reduce the known complications of classic approach. There is a lower rate of hemorrhage and nerve injury in this method. Fibular bone graft will be used to reshape the orbitofrontal deformity. Remodeling will be based on the severity of deformity. We will use imaging for postoperative evaluation. The patient will be visited at least 3 times.
Category
Treatment - Surgery
2
Description
Control group: 5 patients will be treated with classic osteotomy technique. In this method, there is a high probability of hemorrhage and air emboli. Orbitofrontal deformity will be corrected using osteotomy. We will use imaging for postoperative evaluation. The patient will be visited at least 3 times.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Children Hospital
Full name of responsible person
Ali Riazi
Street address
Imam Hossein Children Hospital, Imam Khomeini Avn
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
emamHosseinChildren'sHospital@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
No. 4, Isfahan University of Medical Sciences, Hezar-jarib Avn
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3386 6266
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Ali Riazi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Imam Hosein Children Hospital, Imam Khomeini Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3386 6266
Email
ali_riazi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Riazi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Imam Hosein Children Hospital, Imam Khomeini Ave.
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
ali_riazi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ata Mahdkhah
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Imam Hosein Children Hospital, Imam Khomeini Ave.
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
amahdkhah@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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