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

NCT07056023 | Recruiting

• 1 other identifier: EURJMT
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intraspinal Tumor; Juxtamedullary Tumor

Keywords

intra-dural tumors; spinal meningioma; spinal schwannoma; spinal ependymoma

Outcome Measures

Primary Outcomes (3)

• 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.

  prior and 3 months after resection

• 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

  3 months after resection

• 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.

  prior to surgery and 3 months after surgery

Secondary Outcomes (23)

• Tumor Volume

  prior to surgery and 3 months after surgery

• Spinal Canal Ratio

  prior surgery and 3 moths after surgery

• Functionality: Oswestry disability index (ODI) for tumors in the thoracic and lumbar spine

  prior and 3 months after surgery

• Funtionality: Neck disability index (NDI) for tumors in the cervical spine

  prior surgry and 3 months after surgery

• Local and radicular pain

  prior and 3 months after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults, age ≥18 years, patients treated on intraspinal, extra medullary tumor

You may qualify if:

• Adult, age ≥18 years, patients treated on intraspinal, extra medullary tumor
• Patients must have sufficient cognitive and language skills to give informed consent

You may not qualify if:

• Absence of informed consent
• Lack of ability to consent
• Primary bone tumors invading the intra-spinal space
• Vertebral metastasis

Sponsors & Collaborators

• University Hospital Muenster: lead
• Technical University of Munich: collaborator
• University Hospital Freiburg: collaborator
• Medical University of Cologne: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator

Study Sites (1)

University Hospital Muenster

Münster, Nordrhien Westfalen, 48167, Germany

RECRUITING

MeSH Terms

Conditions

Spinal Cord Neoplasms; Meningioma

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms, Vascular Tissue; Meningeal Neoplasms

Central Study Contacts

Michael Schwake, MD

CONTACT

+49 251 8343930; schwakem@uni-muenster.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Neurosurgery Spine Section

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: July 9, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

DE (1)