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IRCT20110829007441N4 IRCT 2022-12-06 Tehran University of Medical Sciences Investigating the effective causes in the improvement of pain and disability caused by low back pain, as well as the improvement of imaging findings after lumbar spine surgery, which includes the first sacral vertebra, in patients with lumbar canal stenosis Investigating the effect of L5-S1 interbody fusion on functional outcomes and radiological fusion rate following spinal fixation and fusion surgeries including S1 in lumbar canal stenosis patients 2022-12-11 anticipated 32 Complete https://irct.ir/trial/64377 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization: Random allocation of patients will be produced and implemented by a list created by a computer by a researcher who does not cooperate in the clinical part of the trial. Randomization by stratified randomization method will be done based on two neurosurgeon by whom the patients will be operated on, as they will be classified into two groups, neurosurgeon A and neurosurgeon B, to control the confounding effect of the surgeon. Then the patients will be assigned to two treatment and control groups, and for its implementation, the sealed-envelope method will be used, which will be provided to the independent treatment group immediately before the operation. This will be done by an independent person who is unaware of the intervention allocated to the participants, Blinding description: Blinding: In this study, double blinding will be used. The blinding of the evaluating physician will be in such a way that the evaluating physician is unaware of the type of treatment performed for each patient. Also, the patients do not know the type of treatment they received until the end of the study. 2 Lumbar canal stenosis. Intervention 1: Intervention group: With L5-S1 interbody fusion. Intervention 2: Control group: Without L5-S1 interbody fusion. 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 Confidentiality of data
public Dr. Hooshang Saberi
Imam Khomeini Hospital Complex, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1449614535 +98 21 6119 2290 hgsaberi@yahoo.com Tehran University of Medical Sciences scientific Dr Hooshang Saberi
Imam Khomeini Hospital Complex, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1449614535 +98 21 6119 2290 hgsaberi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patient consent to participate in the research project Age> 18 years Confirmation of the diagnosis of lumbar spinal stenosis based on clinical examinations and imaging findings by neurosurgeon and spine and radiologist colleagues. Chronic low back pain for more than six months, persistent low back pain with or without shooting pains to the upper leg, neurogenic claudication, focal tenderness above the lumbar vertebral joint, and hyperextension pain leading to sensory or motor neurological deficit or inability to perform daily tasks Lumbar canal stenosis patients with indications for lumbosacral spine fixation and decompression surgery including: radicular syndrome, failure to respond to non-surgical treatments (rest, medical treatment, physical therapy), foraminal and lateral recess stenosis without central canal stenosis, pain related to disc herniation with radicular symptoms based on radiological or neurological tests (neurological tests include straight-leg raising test, suppress of reflex, motor weakness, sensory dysfunction), cauda equina syndrome, deformity (scoliosis) with an angle of less than 25 degrees in lumbosacral spine, grade I and II spondylolisthesis Evidence of lumbar spinal stenosis based on MRI according to Boden criteria Fixation and fusion have been done in maximum 5 levels for the patient The patient has an indication for screw fixation at S1 level (S1 screw), including L5-S1discectomy, L5-S1 spondylolisthesis, Kissing facet that requires facetectomy. The patient has undergone interbody fusion with Posterior lumbar interbody fusion (PLIF) method More than 50% of the graft used in the operation area should be autograft Iranian citizenship It is possible to follow up the patient and be available to participate in routine follow-up sessions 18 years no limit Both Response to non-surgical treatments Vertebral fracture, tumor or infection in the lumbosacral spine, inflammatory spondylopathy and grade III and IV spondylolisthesis. Suspicion of osteoporosis based on lumbosacral radiography (bone densitometry is done to prove the disease in suspected cases and the loss of bone density (T score less than -2.5) which is average for a healthy and adult person of the same age as osteoporosis Considered to be) Use of triparatide (Sinopar) Scoliosis with a Cobb angle of more than 25 degrees Sagittal imbalance with Sagittal vertical axis (SVA) greater than 9 cm Hip flexion contracture based on Thomas test L5-S1 disc height is not suitable before the operation and this space is collapse and fuse Unilateral L5-S1 instrument Revision surgery pregnant women contraindications for MRI People who do not want to participate in the study despite explaining the benefits of the project and the efforts of the study team to participate People who are not able to communicate in order to respond, such as deaf, blind people, speech problems, etc. People suffering from mental disorders, mental retardation and any psychiatric disorder in the acute stage such as psychosis, who are not treated and are unable to cooperate. M99.53 Intervertebral disc stenosis of neural canal of lumbar region Treatment - Surgery Treatment - Surgery Intervention group: With L5-S1 interbody fusion Control group: Without L5-S1 interbody fusion Radiological fusion rate of the spine at L5-S1 level. Timepoint: 6 month after operation. Method of measurement: Standing lateral and flexion-extension lumbosacral X-ray and determination of fusion rate according to Brantigan-Steffee classification. Post-operative complications. Timepoint: After the operation and during the follow-up. Method of measurement: Based on the observations of the surgeon and the patient's medical record and imaging findings after the operation and during the follow-up. The patient's pain level based on Visual Analogue Scale (low back pain and lower limb pain) after the operation. Timepoint: Before the operation, 2 weeks and 6 months after the operation. Method of measurement: Visual analog scale (Low back pain, Lower limb pain). Functional outcome of patient according to Oswestry disability index (ODI) after the operation. Timepoint: Before the operation, 2 weeks and 6 months after the operation. Method of measurement: Oswestry disability index (ODI). Patient satisfaction with postoperative recovery. Timepoint: 2 weeks and 6 months after the operation. Method of measurement: Satisfaction questionnaire (Asking 4 questions to the patient). Tehran University of Medical Sciences Approved 2022-03-15 Research Ethics Committees of Imam Khomeini hospital complex, Tehran University of Medical Science Imam Khomeini Hospital Complex, Keshavarz Boulevard Tehran Tehran Iran (Islamic Republic of)