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临床试验/NCT03057353
NCT03057353Unknown不适用

Risk Factors for Ligamentum Flavum Hypertrophy in Lumbar Spinal Stenosis Patients From Xinjiang Uygur Autonomous Region of China: a Retrospective, Single-center, Case Analysis

Sixth Affiliated Hospital of Xinjiang Medical University0 个研究点目标入组 104 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
104
主要终点
Ligamentum flavum thickness

研究概览

简要总结

To measure ligamentum flavum thickness in patients with different nationalities, sexes, heights, ages, and weights from Xinjiang Uygur Autonomous Region of China with CT, explore the correlation between various factors and ligamentum flavum thickness, provide reference for pedicle screw placement and lumbar decompression surgery, develop individualized surgical programs, and can effectively reduce the incidence of unnecessary postoperative complications induced by misplacement.

详细描述

History and current related studies With the increase of human social activities, spinal degenerative disease is increasing year by year. Due to the special anatomical structures and biomechanical characteristics, lumbar vertebrae easily suffer from lumbar spinal stenosis. Lumbar spinal stenosis is a medical condition in which the spinal canal narrows and compresses the spinal cord and nerves at the level of the lumbar vertebra. Vertebral spondylolisthesis, facet joint hyperplasia, bony spur posterior extension, intervertebral disc prolapse/protrusion, and ligamentum flavum hypertrophy are common causes for degenerative lumbar spinal stenosis, and ligamentum flavum hypertrophy is one of the important causes for spinal stenosis. When conservative treatment is ineffective, the occurrence of muscle paralysis or bladder symptoms caused by nerve compression requires surgical treatment. Commonly used surgical methods include pedicle screw fixation, flavectomy, laminectomy and facetectomy. Therefore, important anatomical structures will be involved in the operation, such as pedicle, ligamentum flavum, lamina, and articular process.

Many previous studies concern pedicle morphology, lumbar ligamentum flavum, lamina and articular process, and important reference data are listed in Table 1. Safak et al. verified that ligamenta flavum thickness was not associated with sex; ligamenta flavum was remarkably thicker on the left side of segments L4/5 and L5/S1 than that on the right side; ligamenta flavum thickness was not positively correlated with age. Few studies address whether ligamenta flavum thickness was associated with nationality, sex and obesity.

Data collection, management, analysis and open-access

  1. Written and electronic data were collected. The electronic data were stored in a specialized computer, and locked by the data manager. The written data were stored and locked in a reference room. The key was kept by the data manager and laboratory manager.
  2. The locked database was not altered and was preserved, along with the original records. The database was statistically analyzed by a professional statistician.
  3. Prior to any analysis of the data, the analysis plan outlined in this section would be reviewed, and detailed statistical analysis plans would be prepared and approved. All data regarding this trial were preserved by the Sixth Affiliated Hospital, Xinjiang Medical University, China.
  4. Anonymized trial data would be published at www.figshare.com.

Statistical analysis

研究设计

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

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Lumbar spinal stenosis revealed by Lumbar CT images
  • •Complained of low back pain
  • •Age between 45 and 80 years old
  • •Irrespective of sex
  • •Signed informed consent

排除标准

  • •Spinal injury
  • •Spinal tumor
  • •Spinal infection
  • •Congenital or acquired spine deformity
  • •Pulmonary tuberculosis
  • •Severe systemic disease such as malignant tumor
  • •Cannot cope with the doctor due to mental illness or other causes

结局指标

主要结局

Ligamentum flavum thickness

时间窗: from May 2012 to May 2016

Changes in ligamentum flavum thickness were observed under different influential factors.

次要结局

  • Lumbar morphology of patients(from May 2012 to May 2016)

研究者

发起方
Sixth Affiliated Hospital of Xinjiang Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gang Zhou

Attending Physician

Sixth Affiliated Hospital of Xinjiang Medical University

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