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临床试验/NCT06545032
NCT06545032尚未招募不适用

Minimal Invasive Transforaminal Lumbar Interbody Fusion for Degenerative Lumbar and Lumbosacral Spine Diseases : Clinical and Surgical Outcome

Sohag University0 个研究点目标入组 30 人开始时间: 2024年9月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
severity of pain according to visual analog score(vas)

研究概览

简要总结

The aim of this study is to evaluate clinical and surgical outcome of MI-TLIF for degenerative lumbar and lumbosacral spine diseases.

详细描述

Approximately 70% to 85% of adults were affected by low back pain (LBP) at some point during their lifetimes. Numerous anatomic sites can be responsible for the pain, and accurate diagnosis is often difficult. Degenerative lumbar, lumbosacral spine diseases internal disc disruption, lumbar disc herniation, and facet joint arthritis, as well as intra-abdominal pathology, are all potential causes of LBP(Stott and Driscoll, 2024). q Degenerative lumbar and lumbosacral spine diseases are the most rampantly prevalent healthcare problems in the world, with chronic LBP being the second leading cause of adult disability ,The symptoms can broadly be divided into LBP and radicular symptoms in the lower extremities leading in some cases to neurogenic claudication(Shokri et al., 2023).

As an alternative to PLIF, Harms and Rolinger introduced the transforaminal lumbar interbody fusion (TLIF) procedure in 1982 for the management of degenerative spinal disorders that necessitate interbody fusions. The impetus for the development of TLIF was to provide a more lateral approach to the disc space, thus reducing the amount of thecal sac and nerve root retraction. Additionally, in revision cases where scar tissue hinders identification of neural structures, avoidance of midline scar planes with the TLIF procedure is beneficial. Moreover, a circumferential fusion can be achieved from a unilateral approach with the TLIF procedure without having to expose the bilateral epidural space (Karikari, Isaac O. MD; Isaacs, Robert E. MD, 2010).

Technological advances, better magnification and illumination, modern tubular retractors and percutaneous screw systems and more frequent exposure of surgeons to minimally access surgery in their residency training has greatly contributed to the global success of minimal invasive transforaminal lumbar interbody fusion (MI-TLIF). Traditional open spinal fusion surgeries, while effective, are associated with considerable tissue disruption, prolonged recovery times, and higher risks of complications(Prabhu et al., 2022).

MI-TLIFis one such advanced surgical technique designed to treat degenerative conditions of lumbar and lumbosacral spine diseases. Through the tubular expander, MIS-TLIF can reach the facet joints of the diseased segments. MIS-TLIF effectively reduces the peeling and traction injury of the multifidus muscle, prevents postoperative muscle atrophy, and reduces the occurrence of postoperative chronic LBP(Saela et al., 2023).

The MI-TLIF has shown reduced complications, decreased intraoperative blood loss, shorter hospital stays and recovery time, and decreased postoperative narcotic usage while maintaining similar clinical outcomes and fusion rates to conventional open TLIF since its inception (Hong et al., 2022).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Degenerative spondylolisthesis.
  • Degenerative unilateral disc herniations.
  • Recurrent disc herniation.

排除标准

  • Spondylolisthesis Grade III or IV.
  • Degenerative scoliosis .
  • Traumatic fracture spine.
  • Infections.
  • Neoplasms.
  • Debilitated patients .
  • Coagulation dysfunction.
  • Severe osteoporosis.

结局指标

主要结局

severity of pain according to visual analog score(vas)

时间窗: 1 year

comparison between pre \& post operative pain

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdelaleem Mohamed Abdelrahman

assistant lecturer

Sohag University

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