Multicenter Trial on Surgical Outcome and Quality of Life in Juxta-medullary Tumors

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Muenster

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
prior and 3 months after resection
2

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

Time frame
3 months after resection
3

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.

Time frame
prior to surgery and 3 months after surgery

Secondary outcomes

1

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

Time frame
prior to surgery and 3 months after surgery
2

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.

Time frame
prior surgery and 3 moths after surgery
3

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.

Time frame
prior and 3 months after surgery
4

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.

Time frame
prior surgry and 3 months after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Muenster

Lead sponsor

Technical University of Munich

Collaborator

University Hospital Freiburg

Collaborator

Medical University of Cologne

Collaborator

Universitätsklinikum Hamburg-Eppendorf

Collaborator