IRCT20110829007441N4招募中2 期
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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 no limit（—）
- 性别
- All
入选标准
- •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
排除标准
- •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.
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