跳至主要内容
临床试验/NCT06042946
NCT06042946招募中不适用

Microsurgical Resection of Intramedullary Spinal Cord Metastases - a Retrospective International Multicenter Study

Cantonal Hospital of St. Gallen1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Functional outcome at 90 days after treatment initiation

研究概览

简要总结

The aim of the study is to establish a multi-center, retrospective database for patients with intramedullary spinal cord metastases (ISCM) and analyse the functional outcome in surgically treated ISCM patients.

The hypothesis is that the surgical treatment of selected ISCM patients does not lead to persistent morbidity and does not increase mortality, compared to patients that are treated non-operatively.

Secondary objectives are to assess pre- to postoperative neurological deficits, ambulatory status, and overall survival of surgically treated ISCM patients.

The investigators intend to include a control cohort of patients with ISCM from participating centers, who underwent non-surgical oncological treatment (radiotherapy with or without chemotherapy). This control cohort of patients will be used to match patients with and without surgical treatment.

Primary endpoint (analysed in surgically treated ISCM patients):

Functional outcome at 90 days after treatment initiation, measured by the modified McCormick Scale. This is a score for grading of neurological function in spinal cord conditions.

The McCormick scale ranges from Grade I (neurologically intact) to grade V (paraplegic or quadriplegic). The McCormick scale is suitable for our retrospective study because of its good reproducibility and comparability.

Secondary endpoints (analysed in surgically treated ISCM patients and analysed in matched patients with and without surgical treatment):

  • Functional outcome by the McCormick scale and the modified Japanese Orthopaedic Association scale (mJOA) at 6 and 12 months. This is a score evaluating motor function of upper and lower extremities, sensory function of upper extremities and sphincter function / voidance. The mJOA ranges from 0 - 18 points, with higher score values representing better functional outcome. The minimum clinically important difference of the mJOA is 1-2 points, and scores lower than 14 indicate moderate myelopathy, scores lower than 11 indicate severe myelopathy.
  • Ambulatory status and continence at 90 days, 6 & 12 months (determined by mJOA subscores)
  • Neurological outcome, measured by American Spinal Cord Injury Association (ASIA)
  • Impairment Scale at 90 days, 6 and 12 months
  • Rate & type of complications at 90 days after treatment according to The Novel Therapy
  • Disability-Neurology Grade (TDN grade)16
  • Overall survival (in days)

研究设计

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

入排标准

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

入选标准

  • Adult patients admitted to one of the participating centres and treated for ISCM
  • Available documentation of admission and postoperative status

排除标准

  • Patients under the age of 18

结局指标

主要结局

Functional outcome at 90 days after treatment initiation

时间窗: at 90 days after treatment initiation

measured by the modified McCormick Scale. This is a score for grading of neurological function in spinal cord conditions. The McCormick scale ranges from Grade I (neurologically intact) to grade V (paraplegic or quadriplegic). The McCormick scale is suitable for our retrospective study because of its good reproducibility and comparability.

次要结局

  • Rate & type of complications(within 90 days after treatment initiation)
  • Neurological outcome(at 6 and 12 months after treatment initiation)
  • Functional outcome(at 6 and 12 months after treatment initiation)

研究者

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

Felix C. Stengel, MD

Junior Attending Neurosurgeon

Cantonal Hospital of St. Gallen

研究点 (1)

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