About this trial
Primary objectives: Primary objectives are to assess and define benchmarks of the surgical outcome in the form of extent of resection, functionality, and quality of life after resection of juxta medullary tumors Secondary objectives: Assessment of variables leading to better outcome through regression analysis: 1. Influence of surgical approach on functionality, pain, and quality of life 2. Comparison between patient with severe neurological (McCormick scale 3-5) to patients with mild deficits (McCormick scale 1-2) 3. Role of intraoperative monitoring (IOM) in extent of resection and neurological deficits Assessment of treatment variations: 1. Assessment of risk factors for incomplete resection 2. Non inferiority of unilateral approach to achieve gross total resection of spinal meningioma, schwannoma and cauda ependymoma 3. Role of bed rest after surgery to prevent cerebro-spinal fluid leakage 4. Influence of laminectomy on cerebro-spinal fluid leakage Quality indicators: assessments of length of hospital stay, 30- and 90-days re-admissions, 30- and 90-days re-surgery, nosocomial infections
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult, age ≥18 years, patients treated on intraspinal, extra medullary tumor
Patients must have sufficient cognitive and language skills to give informed consent
Disqualifiers
Absence of informed consent
Lack of ability to consent
Primary bone tumors invading the intra-spinal space
Vertebral metastasis
Trial population
Adults, age ≥18 years, patients treated on intraspinal, extra medullary tumor
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Quality of life based on the questionnaire
The EuroQol 5-Dimension questionnaire (EQ-5D) is a standardized measure of health-related quality of life. It includes five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each rated on 3 or 5 levels, and a visual analogue scale (EQ VAS) from 0 (worst health imaginable) to 100 (best health imaginable). Higher EQ VAS scores indicate better health status. The descriptive system can also be converted to an index score ranging typically from \<0 (worse than death) to 1 (perfect health), where higher values reflect better health.
Extent of tumor resection
1\. Meningioma: Simpson grade 1 and 2 2. Schwannoma: complete resection, including nerve root 3. Cauda ependymoma: complete resection, including filum terminale according to postoperative MRI, 3 months after surgery 4. Other: surgeon's decision
Neurological status
The McCormick Functional Classification Scale for Spinal Cord Tumors assesses functional impairment in patients with intramedullary spinal tumors. It ranges from Grade I (minimal symptoms, fully active) to Grade IV (severe disability, dependent). The scale has four grades, with Grade I as the best and Grade IV as the worst outcome. Higher grades indicate greater neurological impairment and reduced functional independence.
Secondary outcomes
Tumor Volume
The Tumor Volume on MRI Scans measures the three-dimensional size of a tumor using magnetic resonance imaging. It is typically calculated by multiplying tumor dimensions (length × width × height) and applying a correction factor (e.g., ×0.5 for ellipsoid shapes). Volume is expressed in cubic millimeters (mm³) or centimeters (cm³). There is no fixed minimum or maximum, as values depend on tumor size
Spinal Canal Ratio
The Spinal Canal Ratio (also called the Spinal Canal Occupation Ratio) quantifies spinal canal narrowing, typically in cases of spinal stenosis or tumors. It is calculated as the ratio of the space occupied by the lesion (e.g., tumor or disc) to the total area of the spinal canal on axial imaging. Values range from 0 (no compression) to 1 (100% occupation of the canal). Higher values indicate worse outcomes, reflecting more severe canal compromise and potential cord compression.
Functionality: Oswestry disability index (ODI) for tumors in the thoracic and lumbar spine
The Oswestry Disability Index (ODI) is a patient-reported questionnaire used to assess disability due to lower back pain. It includes 10 sections covering pain intensity and functional limitations (e.g., walking, lifting, sleeping), each scored from 0 to 5. The total score is converted to a percentage from 0% (no disability) to 100% (maximum disability). Higher scores indicate worse outcomes, reflecting greater functional impairment. The ODI is widely used to evaluate treatment effectiveness and monitor progress in patients with spinal disorders.
Funtionality: Neck disability index (NDI) for tumors in the cervical spine
The Neck Disability Index (NDI) is a validated, patient-reported questionnaire used to measure self-rated disability related to neck pain. It includes 10 items covering pain intensity and daily activities (e.g., personal care, lifting, concentration), each scored from 0 to 5. The total score ranges from 0 to 50, which is often expressed as a percentage (0% to 100%), where 0 indicates no disability and 100 indicates complete disability. Higher scores represent worse outcomes, reflecting greater functional impairment due to neck pain.
Sponsors and contacts
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University Hospital Muenster
Lead sponsor
Technical University of Munich
Collaborator
University Hospital Freiburg
Collaborator
Medical University of Cologne
Collaborator
Universitätsklinikum Hamburg-Eppendorf
Collaborator