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IRCT20251010067572N1 IRCT 2025-11-05 Tehran University of Medical Sciences Comparison of clinical and radiological outcomes between two methods of using cortical screws and pedicle screws in multilevel lumbar spine fusion surgery Comparison of clinical and radiological outcomes between two methods of using cortical screws and pedicle screws in multilevel lumbar spine fusion surgery at Imam Khomeini Hospital, Tehran 2025-09-29 anticipated 102 Recruiting https://irct.ir/trial/86792 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be assessed for eligibility and, after obtaining written informed consent and basic information, will be randomly assigned to either Group A (PS screw) or Group B (CS screw). The patient will be blinded to the group assignment, but the surgeon and the medical staff will not be blinded; therefore, the study will be considered a single-blind study. Randomization will be performed using a block randomization approach. A detailed, step-by-step procedure for performing block randomization for a clinical trial with 102 patients in two groups of 51 is presented: Objective: To randomly assign 102 patients to two equal groups (CBT screw group and pedicle screw group) in such a way that a relative balance between the number of participants in each group is maintained at each stage of patient recruitment. 1. Design specifications Total number of participants: 102 Number of groups: 2 groups (CBT and Pedicle) Allocation ratio: 1:1 Randomization method: Block randomization with variable block size 2. Block size selection To maintain balance while avoiding prediction of allocation, variable block sizes (e.g., 4 and 6) are used: Block 4: includes 2 people in the CBT group and 2 people in the Pedicle group Block 6: includes 3 people in the CBT group and 3 people in the Pedicle group Number of blocks required: Assuming a combination of blocks 4 and 6, to reach 102 people, the total block size must be 102 (12 blocks of 6 people and 3 blocks of 4 people = 102). 3. Generation of random allocation sequences Using the site https://www.sealedenvelope.com/simple-randomiser/v1/lists and Excel, the output of the following steps will be performed: For each block, all possible combinations of symmetric allocation (CBT–Pedicle–CBT–Pedicle) are listed. Using the RAND function in Excel, a random selection is made from these combinations. This is repeated until the total number of subjects is 102. 4. Allocation Concealment The results of the generated random sequence are placed in numbered and sealed envelopes. Each envelope contains a sheet with the name of the allocation group. Only the researcher responsible for allocation (and preferably not involved in the outcome assessment) opens the envelope when the patient enters the study. 5. Allocation Implementation After confirming the inclusion criteria and obtaining informed consent from the patient, the patient is allocated to one of the two groups based on the envelope number (e.g., in order of arrival). The patient’s name, envelope number, and allocation group are entered in the data recording form. 6. Practical example for a block of 4: The same logic is followed for subsequent blocks. To reduce bias in outcome measurement, a consultant radiologist and a consultant neurosurgeon will independently review the radiographs and CT scans of each patient, and disagreements will be resolved by discussion, Blinding description: The patient is blinded to the group allocation, but the surgeon and the treatment staff are not; therefore, the study is considered single-blind. The randomly generated sequence is placed in numbered, sealed envelopes. Each envelope contains a slip of paper with the name of the allocation group. Only the investigator responsible for allocation (and preferably not involved in the outcome assessment) opens the envelope when the patient enters the study. N/A Multilevel lumbar spine fusion surgery. Intervention 1: Intervention group: In the pedicle screws group, the entry site will be at the apex of the herringbone crest and the junction of the transverse process with the lateral edge of the superior articular process. An initial hole will be made using an awl and then advanced into the pedicle canal with the help of a pedicle probe, and finally a 40 mm deep hole will be made at an angle of 10–15 degrees to the superior vertebral plane. The entry site and drill path will be determined with C-arm guidance. After confirming the depth of the hole with a ball-tipped probe, screws of 40–45 mm in length and 6.0 mm in diameter will be inserted. Intervention 2: Control group: In the Cortical screws group, the screw insertion site will be midway between the superior articular process and 1–2 mm below the inferior border of the transverse process. The screw path will be from 5 o'clock to 11 or 12 o'clock on the left side, and from 7 o'clock to 12 or 1 o'clock on the right side. The screw tip will be positioned 1/3 to 1/2 posterior to the superior face of the vertebra. The insertion path will be determined with C-arm guidance. First, a 2-mm burr hole will be created in the cortex of the isthmus to reduce the risk of isthmic fracture, then a primary hole will be created with a 2.5-mm drill to a depth of 30 mm. After confirming the path with a ball-tipped probe, a T-handle instrument will be inserted into the hole. Screws 35–40 mm long and 5.5 mm in diameter will be inserted for fusion. Yes - There is a plan to make this available What will be shared: A thesis and an article of the results of statistical analysis and its discussion When: After defending the thesis and publishing the article To whom: Everyone Conditions: For use in articles Where to obtain: To the Tehran Medical Sciences Research Associate website after registering the thesis or the journal in which it is published. How to obtain: To the Tehran Medical Sciences Research Associate website after registering the thesis or the journal in which it is published. Comments:
public Mohammad Doustkani
End of keshavarz boulevard, doctor gharib street, imam Khomeini hospital complex
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 5920 mohammad.doustkani@gmail.com Tehran University of Medical Sciences scientific Mohammad Doustkani
End of keshavarz boulevard, doctor gharib street, imam Khomeini hospital complex
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 5920 mohammad.doustkani@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Male and female patients 18 years of age and older Patients with low back disease who are candidates for two- to four-level fusion surgery and whose symptoms include radiculopathy and/or nerve palsy, with or without back pain. Patients who have not responded to conservative treatment (medication and physical therapy) for at least 3 months or who have shown progressive neurological symptoms during this treatment. Patients who are willing to sign a research consent and follow-up for at least 1 year. 18 years no limit Both Patients with a T-Score greater than -2.5 in BMD (osteoporosis) Patients with involvement of less than two lumbar spine levels or more than four levels History of lumbar fusion surgery or active local/systemic infection or fracture Pregnant patients Inability to adhere to the 1-year follow-up schedule Use of glucocorticoids or immunosuppressive drugs Spondylolisthesis with Myroding grade ≥ III or IV M48.0 Spinal stenosis Treatment - Surgery Treatment - Surgery Intervention group: In the pedicle screws group, the entry site will be at the apex of the herringbone crest and the junction of the transverse process with the lateral edge of the superior articular process. An initial hole will be made using an awl and then advanced into the pedicle canal with the help of a pedicle probe, and finally a 40 mm deep hole will be made at an angle of 10–15 degrees to the superior vertebral plane. The entry site and drill path will be determined with C-arm guidance. After confirming the depth of the hole with a ball-tipped probe, screws of 40–45 mm in length and 6.0 mm in diameter will be inserted. Control group: In the Cortical screws group, the screw insertion site will be midway between the superior articular process and 1–2 mm below the inferior border of the transverse process. The screw path will be from 5 o'clock to 11 or 12 o'clock on the left side, and from 7 o'clock to 12 or 1 o'clock on the right side. The screw tip will be positioned 1/3 to 1/2 posterior to the superior face of the vertebra. The insertion path will be determined with C-arm guidance. First, a 2-mm burr hole will be created in the cortex of the isthmus to reduce the risk of isthmic fracture, then a primary hole will be created with a 2.5-mm drill to a depth of 30 mm. After confirming the path with a ball-tipped probe, a T-handle instrument will be inserted into the hole. Screws 35–40 mm long and 5.5 mm in diameter will be inserted for fusion. The patient's degree of functional disability in daily activities. Timepoint: At intervals before surgery/at discharge/one month after surgery/three months after surgery/one year after surgery. Method of measurement: ODI questionnaire. Facet joint injury rate. Timepoint: After surgery. Method of measurement: CT scan. Screw placement accuracy. Timepoint: After surgery. Method of measurement: CT scan. Fusion rate. Timepoint: At three and twelve months after surgery. Method of measurement: Ct scan. Loosening of screws. Timepoint: At three and twelve months after surgery. Method of measurement: Ct scan. Tehran University of Medical Sciences Approved 1995-09-19 Ethics committee of Tehran University of Medical Sciences End of keshavarz boulevard, doctor gharib street, imam Khomeini hospital complex Tehran Tehran Iran (Islamic Republic of)