]>
IRCT20220816055722N1 IRCT 2022-12-03 Esfahan University of Medical Sciences Correction of forehead and orbit deformities in patients with non-syndromic craniosynostosis Comparison of the effect of bone increment technique and osteotomy on frontoorbital deformity in patients with non-syndromic craniosynostosis 2022-09-06 anticipated 10 Complete https://irct.ir/trial/65310 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A Craniosynostosis. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Ali Riazi
Imam Hosein Children Hospital, Imam Khomeini Ave.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3386 6266 ali_riazi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Ali Riazi
Imam Hosein Children Hospital, Imam Khomeini Ave.
Isfahan Iran (Islamic Republic of) 8195163381 +98 31 3386 6266 ali_riazi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with non-syndromic simple coronal suture craniosynostosis Patients with non-syndromic simple metopic suture craniosynostosis 3 months 3 years Both Lack of informed consent of parents The presence of any underlying disease that is a contraindication for surgery Previous history of skull surgery Q75.0 Craniosynostosis Treatment - Surgery Treatment - Surgery 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. 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. Correction of deformity of the forehead and orbit. Timepoint: Before intervention and three months after intervention. Method of measurement: CT Scan. Esfahan University of Medical Sciences Approved 2022-07-17 Ethics committee of Medical Faculty of Isfahan University of Medical Sciences No. 4, Isfahan University of Medical Sciences, Hezar Jerib Ave; Telephone:03137923084 Isfahan Isfehan Iran (Islamic Republic of)