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IRCT20210406050867N1 IRCT 2021-09-28 Esfahan University of Medical Sciences Cervical collar after anterior discectomy surgery of a neck surface Evaluation of the effectiveness of comparing short and long-term use of cervical collar after anterior cervical discectomy on vertebral fusion and its outcome 2021-08-23 anticipated 70 Complete https://irct.ir/trial/57730 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random function of Excel software based on patient file number will be used for randomization. Patients with a cervical disc were entered into Excel based on the file number and divided into case and control groups based on the random button. In total, there were two groups of 35 people. By entering the file number in Excel program, then the random number is selected from the data analysis command. This study has 2 groups that can be numbered from 1 to 2, respectively. We also want to have 70 people in each group. As a result, sequences 1 to 2 should be repeated 100 times each time. It is clear that the repetition of each number occurs once in each group, so select 1 for repeating each number and 35 for repeating the sequence. In this way, 70 units will be produced. N/A Symptomatic one level cervical disc herniation. Intervention 1: Intervention group: Candidate for collar closure for two months-Patients after Discectomy surgery and cervical implantation with cage, after transfering to the ward, except in the supine position (sitting, standing and moving) continuously use the collar neck. Intervention 2: Control group: Candidate for collar closure for two weeks. 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 more information
public Mehdi Shafiei
Isfahan University of Medical Sciences, Hezar Jarib St.,
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 Mehdishafiei82@gmail.com Esfahan University of Medical Sciences scientific Mehdi Shafiei
Isfahan University of Medical Sciences, Hezar Jarib St.,
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 Mehdishafiei82@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patient with a single cervical disc herniation The need for surgical intervention that requires the release of pressure from the spinal cord. No history of underlying diseases such as diabetes and neuropathy and heart disease No smoking and addiction Satisfaction to participate in the study 20 years 60 years Both Patients who need surgery for more than one cervical disc herniation. Patients who have previously undergone cervical spine surgery. Age over 60 years. Patients who need fixation with screws and plates. Patients who are undergoing posterior neck surgery or need it in the future. Incidence of surgical complications during surgery (root injury, thecal sac rupture, etc.) M50 Cervical disc disorders Treatment - Devices Treatment - Devices Intervention group: Candidate for collar closure for two months-Patients after Discectomy surgery and cervical implantation with cage, after transfering to the ward, except in the supine position (sitting, standing and moving) continuously use the collar neck. Control group: Candidate for collar closure for two weeks The amount of fusion on the radiograph. Timepoint: At the time of referral, two weeks later and two months later. Method of measurement: Fusion criteria in radiography. Healing axial pain. Timepoint: At the time of referral, two weeks later and two months later. Method of measurement: pain scale and anesthesia. Esfahan University of Medical Sciences Approved 2021-03-17 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib St., Shiraz Gate Isfahan Isfehan Iran (Islamic Republic of)