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IRCT20141209020258N177 IRCT 2022-11-24 Arak University of Medical Sciences Comparison of two methods of vertebral fixation through pedicle screwing and pedicle screwing with kyphoplasty during recovery and pain and pull out screws in patients with lumbar or dorsal vertebral fracture Comparison of two methods of vertebral fixation through pedicle screwing and pedicle screwing with kyphoplasty during recovery and pain and pull out screws in patients with lumbar or dorsal vertebral fracture 2022-11-22 anticipated 40 Complete https://irct.ir/trial/66801 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be allocated into 2 groups using a permuted balanced block randomization method with the size of blocks 4 and 8. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method, Blinding description: Surgery is performed by a neurosurgeon and follow-up and examination of patients is performed by a resident. And the analyzer will also be unaware of groups. The study is double-blind. It should be noted that in order to be a double-blind study, the data is collected by a specialized assistant who was unaware of the groupings. 2-3 lumbar or dorsal vertebral fracture. Intervention 1: Intervention group 1: In this group, pedicle screw placement is done. At the beginning of the surgery, the fixation level should reach a level so that the spine is exposed. The entry point of the pedicle screw in the vertebrae of the lumbar arch is determined based on the intersection point of each of the four lines: • Pars interarticularis • Mamillary process • Lateral border of the superior articular facet • Mid transverse process The entry point of the pedicle screw in the sections The bottom of the thoracic arch is determined after determining the intersection of the middle part of the facet joint (the joint between the vertebrae) and the upper edge of the transverse process. The entry point of the screw is in the lateral and end part of this intersection. Guide points: • Lateral border of the superior facet • Lateral border of the inferior facet • Ridge of the pars interarticularis • Transverse process To split the cortex surface as an entry point, you can use drill and rongeur used. Terminal angle of the skull: a pedicle rod is used to guide the path towards the vertebral body. The correct progress of the pedicle rod in the final path of the skull depends on the contralateral transverse process and causes the hole to be created in a direction parallel to the original surface. Medial-lateral tilt: Medial-lateral tilt depends on the rotation of the vertebra and its location up to 45 degrees in L5 or 0 degrees It is approved in T5. In the case of deep insertion, the important point is to prevent penetration into the inner part of the spinal canal and lateral or anterior penetration into the cortex of the vertebral body. Ideally, the path of the two screws should be close to each other, while only being placed in the cortex of the pedicle and its body. Screw placement: The pedicle screw with the appropriate diameter and length is selected by the surgeon using a special device completely. It is placed in the created channel and fills the entire channel. Throughout this process, radiographic images can be used to ensure the correct placement of the screw. Depending on the surgeon, a single or multi-axis screw is selected for the operation. Intervention 2: Intervention group 2: Kyphoplasty will be performed along with pedicle screw placement. After the pedicle screw placement is done, two small and special needles are inserted into the broken area using anesthesia. Then, with the help of a balloon, the structure of the spine and vertebrae is formed, and then bone cement is poured into the vertebrae to harden them. This surgery takes one hour for each broken vertebra. 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 Dr Alireza Kamali
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 68 3222 2003 alikamaliir@yahoo.com Arak University of Medical Sciences scientific Dr Ali Nazemi Rafie
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 nazemi@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) All patients candidates for lumbar or back fracture surgery Age 18 years and above 18 years no limit Both underlying diseases history of thromboembolism pathological fracture underlying bone disease S32.0 Fracture of lumbar vertebra Treatment - Surgery Treatment - Surgery Intervention group 1: In this group, pedicle screw placement is done. At the beginning of the surgery, the fixation level should reach a level so that the spine is exposed. The entry point of the pedicle screw in the vertebrae of the lumbar arch is determined based on the intersection point of each of the four lines: • Pars interarticularis • Mamillary process • Lateral border of the superior articular facet • Mid transverse process The entry point of the pedicle screw in the sections The bottom of the thoracic arch is determined after determining the intersection of the middle part of the facet joint (the joint between the vertebrae) and the upper edge of the transverse process. The entry point of the screw is in the lateral and end part of this intersection. Guide points: • Lateral border of the superior facet • Lateral border of the inferior facet • Ridge of the pars interarticularis • Transverse process To split the cortex surface as an entry point, you can use drill and rongeur used. Terminal angle of the skull: a pedicle rod is used to guide the path towards the vertebral body. The correct progress of the pedicle rod in the final path of the skull depends on the contralateral transverse process and causes the hole to be created in a direction parallel to the original surface. Medial-lateral tilt: Medial-lateral tilt depends on the rotation of the vertebra and its location up to 45 degrees in L5 or 0 degrees It is approved in T5. In the case of deep insertion, the important point is to prevent penetration into the inner part of the spinal canal and lateral or anterior penetration into the cortex of the vertebral body. Ideally, the path of the two screws should be close to each other, while only being placed in the cortex of the pedicle and its body. Screw placement: The pedicle screw with the appropriate diameter and length is selected by the surgeon using a special device completely. It is placed in the created channel and fills the entire channel. Throughout this process, radiographic images can be used to ensure the correct placement of the screw. Depending on the surgeon, a single or multi-axis screw is selected for the operation. Intervention group 2: Kyphoplasty will be performed along with pedicle screw placement. After the pedicle screw placement is done, two small and special needles are inserted into the broken area using anesthesia. Then, with the help of a balloon, the structure of the spine and vertebrae is formed, and then bone cement is poured into the vertebrae to harden them. This surgery takes one hour for each broken vertebra. Average amount (Proximal Junctional Kyphosis). Timepoint: 6 months and one year after the operation. Method of measurement: Radiography. The average rate of Proximal Junctional Failure. Timepoint: 6 months and one year after the operation. Method of measurement: Radiography. Average wear of screws. Timepoint: 6 months and one year after the operation. Method of measurement: Radiography. Mean of pain. Timepoint: 1.5, 3, 6 and 12 months after surgery. Method of measurement: Pain Visual Analog Questionnaire. Average time of recovery and return to normal life. Timepoint: After surgery. Method of measurement: Physical examination. The amount of pseudoarthrosis. Timepoint: 6 months and one year after the operation. Method of measurement: Radiography. Arak University of Medical Sciences Approved 2022-04-03 Ethics comittee of Arak University of Medical Sciences Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak Arak Markazi Iran (Islamic Republic of)