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临床试验/NCT05033457
NCT05033457Enrolling By Invitation不适用

Comparative Study Between Unilateral Biportal Endoscopy Technique and Percutaneous Endoscopic Transforaminal Discectomy for the Treatment of Lumbar Spinal Canal Stenosis

Shaanxi Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
100
试验地点
1
主要终点
Cross-sectional area of the preoperative lumbar intervertebral disc

研究概览

简要总结

OBJECTIVE Both unilateral biportal endoscopy technique(UBE) and percutaneous endoscopic transforaminal discectomy(PETD) are minimally invasive and effective surgical procedures for lumbar spinal stenosis.The object of this retrospective study was to compare the clinical and radiological outcomes between UBE and PETD.

METHODS In the period from July 2020 to December 2020, using UBE or PETD to treat lumbar canal stenosis.Patients were classified into two groups based on the surgery they had undergone. Preoperative and postoperative MR image was used to evaluate the removal rate of lumbar disc herniated material by two surgical methods. The two surgical methods are also compared and evaluated in terms of operation time, incision size, hospitalization time, etc.

详细描述

It was performed as a retrospective analysis of prospectively collected data on patients received spinal endoscopic decompression between July 2020 to December 2020 was conducted. All patients underwent lumbar MRI examination with the result of L5-S1 disc herniation,accompanied by claudication or lower extremity radiation pain and other nerve compression symptoms. The symptoms have not improved with conservative treatments including physical therapy, medication, and epidural injection procedures for a minimum of 12 weeks. Patients who hadprevious spine surgery, infection, trauma, tumors or spondylolisthesis were excluded. The surgery was performed by the same experienced spinal surgeon and the surgical patient were closely followed for 3 months after surgery.

The investigators performed two kinds of endoscopic lumbar discectomy:unilateral biportal endoscopy technique(UBE) and percutaneous endoscopic transforaminal discectomy(PETD).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Single-segment lumbar disc herniation/lumbar spinal stenosis

排除标准

  • Multi-segment lumbar disc herniation / lumbar spinal stenosis、Have received surgery、Hypertension、Diabetes
  • Inclusion Criteria:
  • Inclusion Criteria:
  • Single-segment lumbar disc herniation Symptoms of nerve compression
  • Exclusion Criteria:
  • foraminal and extraforaminal disc herniation multilevel disc herniation, spinal stenosis spondylolisthesis scoliosis prior lumbar surgery spinal infection spinal tumor a history of hip or knee arthritis

结局指标

主要结局

Cross-sectional area of the preoperative lumbar intervertebral disc

时间窗: preoperative

The preoperative axial T2-weighted MRI slices of the patient can be used to measure the cross-sectional area of the intervertebral disc of the diseased segment.

Cross-sectional area of the preoperative spinal canal

时间窗: preoperative

The preoperative axial T2-weighted MRI slices of the patient can be used to measure the cross-sectional area of the spinal canal of the diseased segment.

Cross-sectional area of the postoperative lumbar intervertebral disc

时间窗: 3 months after surgery

The postoperative axial T2-weighted MRI slices of the patient can be used to measure the cross-sectional area of the intervertebral disc of the diseased segment.

preoperative ODI

时间窗: preoperative

According to the Oswestry Disability Index (ODI), evaluate the preoperative ODI of participants.

preoperative VAS back pain score

时间窗: preoperative

According to the visual analog scale (VAS) scoring standard, assess the preoperative VAS back pain score of participants.

preoperative VAS leg pain score

时间窗: preoperative

According to the visual analog scale (VAS) scoring standard, assess the preoperative VAS leg pain score of participants.

VAS back pain score on 3 months after operation

时间窗: 3 months after operation

According to the visual analog scale (VAS) scoring standard, assess the VAS back pain score of participants on 3 months after operation.

VAS leg pain score on 3 months after operation

时间窗: 3 months after operation

According to the visual analog scale (VAS) scoring standard, assess the VAS leg pain score of participants on 3 months after operation.

VAS back pain score at the final follow-up

时间窗: Final follow-up

According to the visual analog scale (VAS) scoring standard, assess the VAS back pain score of participants at the final follow-up.

VAS leg pain score at the final follow-up

时间窗: Final follow-up

According to the visual analog scale (VAS) scoring standard, assess the VAS leg pain score of participants at the final follow-up.

ODI on 3 months after operation

时间窗: 3 months after surgery

According to the Oswestry Disability Index (ODI), evaluate the ODI of participants on 3 months after operation.

ODI at the final follow-up

时间窗: Final follow-up

According to the Oswestry Disability Index (ODI), evaluate the ODI of participants at the final follow-up.

VAS back pain score on postoperative day 1

时间窗: 1 day after operation

According to the visual analog scale (VAS) scoring standard, assess the VAS back pain score of participants on postoperative day 1.

VAS leg pain score on postoperative day 1

时间窗: 1 day after operation

According to the visual analog scale (VAS) scoring standard, assess the VAS leg pain score of participants on postoperative day 1.

次要结局

  • operation time(intraoperative)
  • incision size(intraoperative)

研究者

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

Rongcan Liu

Director

Shaanxi Provincial People's Hospital

研究点 (1)

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