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IRCT20171124037606N4 IRCT 2023-05-08 Iran University of Medical Sciences The effect of autologous platelet-rich plasma on spinal arthrodesis Comparing the effectiveness of autologous PRP in postrolateral arthrodesis of lumbar spine surgery 2021-10-01 anticipated 20 Complete https://irct.ir/trial/69832 interventional Randomization: N/A, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: The outcome evaluators, who are two radiologists, entered their evaluations in separate questionnaires and numerically, and considering that the interventional material is not visible in the imaging, in relation to which side of the patient's spine (right or left) They are completely unaware of the intervention. The data analyst, who is a statistician, also receives the data numerically and is unaware of which side of the patient's spine (right or left) the intervention took place. 3 Postrolateral arthrodesis after lumbar spine fixation. Intervention 1: Intervention group: On the day of surgery, 26 cc of venous blood was taken from the patient under sterile conditions and placed in 3 special tubes for the preparation of platelet-rich plasma (manufactured by Becton Dickinson) containing 1.5 cc of Acid Citrate Dextrose (ACD) with a volume of 8.5 cc. are poured and transferred to the laboratory. In the laboratory, platelet-rich plasma is prepared by the double spin method, in this way, first all 3 tubes are placed in a centrifuge (Pars Azma model SH.13) with 1600 rpm for 12 minutes and after finishing the layer work The plasma is separated under sterile conditions and enters the test tube without anticoagulant. Then it is placed again in the centrifuge with 2700 rpm for 5 minutes. After finishing the work, the upper two-thirds of the plasma is separated from the tube and the remaining one-third is gently shaken in a pendulum after a 5-minute rest so that the concentrated platelets merge with the plasma. Then the platelet-rich plasma was transferred to the operating room and at the end of the operation, 2 cc per vertebra in combination with allograft bone (manufactured by Ceno Bone Company) in the posterolateral space on the right or left side of the vertebral column and then the combination of allograft bone with 2 CC of normal saline serum is placed for each vertebra in the posterolateral space on the opposite side of the vertebral column. Then, the patient was followed up for one year with CT scan imaging in the third, sixth and twelfth months after the operation, and the amount of arthrodesis based on the Hounsfield index was numerically calculated in separate questionnaires by two radiologists who did not know about the side of the intervention. will be recorded. Then the average of the reported numbers is delivered to the statistician for statistical calculations. Intervention 2: Control group: the posterolateral space of the vertebral column on the opposite side in the patients of the intervention group, where the combination of 2 cc of normal saline serum is placed for each vertebra along with the bone graft. Then, the patient was followed up for one year with CT scan imaging in the third, sixth and twelfth months after the operation, and the amount of arthrodesis based on the Hounsfield index was numerically calculated in separate questionnaires by two radiologists who did not know about the side of the intervention. will be recorded. Then the average of the reported numbers is delivered to the statistician for statistical calculations. Yes - There is a plan to make this available What will be shared: After de-identifying people, the information about the main outcome will be accessible When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: For research purposes, descriptive raw data is made available at the discretion of the University Research Committee Where to obtain: by Email: tabibkhooei.a@iums.ac.ir How to obtain: After receiving the email about making the information available after checking the qualification of the researcher by the research committee, the information will be sent to the academic email address of the person within a week. Comments:
public Alireza Tabibkhooei
Rasool Akram Hospital, Niyayesh Avenue, Sattarkhan Avenue
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2228 tabibkhooei.a@iums.ac.ir Iran University of Medical Sciences scientific Alireza Tabibkhooei
Rasool Akram Hospital, Niyayesh Avenue, Sattarkhan Avenue
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2228 tabibkhooei.a@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patients with lumbar spine fracture Patients with lumbar canal stenosis Patients with lumbar spondylolisthesis 16 years 69 years Both Patients with a history of spine surgery Patients suspected of local infection of the spine Patients with canal stenosis or fractures of cervical and thoracic vertebrae Patients with malignancy Patients treated with immunosuppressive drugs Patients with platelet disorders Patients with severe osteoporosis M96.0 Pseudarthrosis after fusion or arthrodesis Treatment - Drugs Placebo Intervention group: On the day of surgery, 26 cc of venous blood was taken from the patient under sterile conditions and placed in 3 special tubes for the preparation of platelet-rich plasma (manufactured by Becton Dickinson) containing 1.5 cc of Acid Citrate Dextrose (ACD) with a volume of 8.5 cc. are poured and transferred to the laboratory. In the laboratory, platelet-rich plasma is prepared by the double spin method, in this way, first all 3 tubes are placed in a centrifuge (Pars Azma model SH.13) with 1600 rpm for 12 minutes and after finishing the layer work The plasma is separated under sterile conditions and enters the test tube without anticoagulant. Then it is placed again in the centrifuge with 2700 rpm for 5 minutes. After finishing the work, the upper two-thirds of the plasma is separated from the tube and the remaining one-third is gently shaken in a pendulum after a 5-minute rest so that the concentrated platelets merge with the plasma. Then the platelet-rich plasma was transferred to the operating room and at the end of the operation, 2 cc per vertebra in combination with allograft bone (manufactured by Ceno Bone Company) in the posterolateral space on the right or left side of the vertebral column and then the combination of allograft bone with 2 CC of normal saline serum is placed for each vertebra in the posterolateral space on the opposite side of the vertebral column. Then, the patient was followed up for one year with CT scan imaging in the third, sixth and twelfth months after the operation, and the amount of arthrodesis based on the Hounsfield index was numerically calculated in separate questionnaires by two radiologists who did not know about the side of the intervention. will be recorded. Then the average of the reported numbers is delivered to the statistician for statistical calculations. Control group: the posterolateral space of the vertebral column on the opposite side in the patients of the intervention group, where the combination of 2 cc of normal saline serum is placed for each vertebra along with the bone graft. Then, the patient was followed up for one year with CT scan imaging in the third, sixth and twelfth months after the operation, and the amount of arthrodesis based on the Hounsfield index was numerically calculated in separate questionnaires by two radiologists who did not know about the side of the intervention. will be recorded. Then the average of the reported numbers is delivered to the statistician for statistical calculations. Arthrodesis rate based on Hounsfield index in CT scan images. Timepoint: Evaluation of posterolateral arthrodesis in the third, sixth and twelfth months after surgery. Method of measurement: Helical 16-slice CT scan machine. Iran University of Medical Sciences Approved 2021-09-26 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)