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IRCT20251020067698N1 IRCT 2025-11-12 Dezfoul University of Medical Sciences Evaluating the appropriate duration of cervical collar use after cervical spine fusion surgery Cervical-Collar-PCF Trial Investigating the effect of cervical collar duration on fusion outcomes after posterior cervical fusion surgery: a randomized clinical trial 2026-03-21 anticipated 60 Recruiting https://irct.ir/trial/86960 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: The randomization method is simple randomization. The unit of randomization is individual. No stratification is applied. The randomization tool is SPSS software version 24 using a random number generator. Sequence generation: After patient enrollment and consent, the unique ID is entered into SPSS; even numbers are assigned to the 6-week group, odd numbers to the 12-week group. Allocation ratio is 1:1. Allocation concealment is achieved using sequentially numbered, opaque, sealed envelopes (SNOSE). The allocation list is prepared by an independent research nurse and placed in envelopes. Envelopes are stored in a locked cabinet. The envelope is opened in the presence of the patient by the research nurse. The investigator, surgeon, and patient remain blinded to the allocation until the envelope is opened. 3 Cervical vertebral fusion following posterior cervical fusion surgery (PCF). Intervention 1: Patients in this group use a Philadelphia Collar for 6 weeks after posterior cervical fusion surgery.The collar is rigid and standard model.Manufacturer: Iran Medical Equipment Co. or equivalent (Aspen/Össur).The collar is worn 24 hours daily except during bathing.Training on collar application and adjustment is provided by the research nurse on postoperative day 1.Weekly follow-up by the research nurse to ensure compliance and check for skin complications. Intervention 2: Intervention group:Patients in this group use a Philadelphia Collar for 12 weeks after posterior cervical fusion surgery.The collar is rigid and standard model.Manufacturer: Iran Medical Equipment Co. or equivalent (Aspen/Össur).The collar is worn 24 hours daily except during bathing.Training on collar application and adjustment is provided by the research nurse on postoperative day 1.Weekly follow-up by the research nurse to ensure compliance and check for skin complications. 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 It is not yet known if there will be a plan to make this available
public Sara Kord
Azadegan Blvd., Next to Traffic Police Department, Dezful
Dezfoul Iran (Islamic Republic of) 6461663911 +98 937 674 1216 bahare.kord132@gmail.com Dezfoul University of Medical Sciences scientific Sara Kord
Dezful, Azadegan Boulevard, next to the Traffic Police Department, Dezful University of Medical Sciences and Health Services
Dezfoul Iran (Islamic Republic of) 6461663911 +98 937 674 1216 bahare.kord132@gmail.com Dezfoul University of Medical Sciences Iran (Islamic Republic of) Patients are candidates for posterior cervical fusion (PCF) surgery. Patient age is between 18 and 60 years. Patient has no prior cervical spine surgery. Patient has no severe comorbidities. Patient is a non-smoker and does not use illicit drugs. Patient can understand the informed consent form. Patient provides written informed consent. no limit no limit Both Patient has previous cervical spine surgery. Patient age is under 18 years. Patient requires anterior fixation . Patient has uncontrolled diabetes. Patient has advanced cardiac disease. Patient has peripheral neuropathy. Patient is pregnant . Patient uses chronic corticosteroids. Patient age is over 60 years. Patient requires anterior plating. Patient is breastfeeding. Patient uses immunosuppressive drugs. M50.2 Other cervical disc displacement Other Other Patients in this group use a Philadelphia Collar for 6 weeks after posterior cervical fusion surgery.The collar is rigid and standard model.Manufacturer: Iran Medical Equipment Co. or equivalent (Aspen/Össur).The collar is worn 24 hours daily except during bathing.Training on collar application and adjustment is provided by the research nurse on postoperative day 1.Weekly follow-up by the research nurse to ensure compliance and check for skin complications. Intervention group:Patients in this group use a Philadelphia Collar for 12 weeks after posterior cervical fusion surgery.The collar is rigid and standard model.Manufacturer: Iran Medical Equipment Co. or equivalent (Aspen/Össur).The collar is worn 24 hours daily except during bathing.Training on collar application and adjustment is provided by the research nurse on postoperative day 1.Weekly follow-up by the research nurse to ensure compliance and check for skin complications. Rate of successful cervical vertebral fusion after posterior cervical fusion surgery, based on radiographic findings and fusion assessment criteria. Timepoint: Six months after surgery. Method of measurement: Radiographic evaluation (X-ray or CT scan) by a blinded assessor using the vertebral fusion assessment scale. Vice Presidency of Education, Research, and Technology, Dezful University of Medical Sciences Approved 2025-05-12 Ethics Committee of Dezful University of Medical Sciences Khuzestan Province, Dezful City, Ayatollah Ghazi Boulevard, Dezful Grand Hospital, Department of Neurosurgery, Dezful University of Medical Sciences Dezfoul Khouzestan Iran (Islamic Republic of)