Functional Outcome, Radiotherapy; Complications, Spinal Cord Metastasis, Spinal Cord Neoplasms, Spinal Cord Tumor Malignant Intramedullary
Conditions
Keywords
Spinal cord metastasis
Brief summary
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)
Interventions
PROCEDUREMicrosurgical resection of ISCM
Microsurgical resection of ISCM defines the surgical removal of cancerous tumors that have spread to the spinal cord, using advanced microsurgical techniques and equipment like ultrasound, neuromonitoring, ultrasonic aspirator to prevent damage to the spinal cord.
Sponsors
University Hospital, Zürich
Insel Gruppe AG, University Hospital Bern
University Hospital, Geneva
Kantonsspital Aarau
Kantonsspital Winterthur KSW
Luzerner Kantonsspital
Klinikum rechts der Isar Technische Universität München
University Hospital Muenster
University of Toronto
Stanford University
Cantonal Hospital of St. Gallen
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients admitted to one of the participating centres and treated for ISCM * Available documentation of admission and postoperative status
Exclusion criteria
\- Patients under the age of 18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional outcome at 90 days after treatment initiation | 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
| Measure | Time frame | Description |
|---|---|---|
| Functional outcome | at 3, 6 and 12 months after treatment initiation | modified Japanese Orthopaedic Association Score (mJOA) Range 0-18, with lower scores indicate a more sever myelopathy |
| Neurological outcome | at 6 and 12 months after treatment initiation | measured by American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS) A: Complete. No sensory or motor function is preserved in sacral segments S4-S5, no sacral sparing B: Sensory Incomplete. Sensory but not motor function is preserved below the neurological level and includes sacral segments S4-S5, AND No motor function is preserved more than three levels below the motor level on either side of the body C: Motor Incomplete. Motor function is preserved below the neurological level AND More than half of the key muscle functions below the neurological level of injury have a muscle grade of less than 3 (Grades 0-2) D: Motor Incomplete. Motor function is preserved below the neurological level AND At least half (half or more) of the key muscle functions below the neurological level of injury have a muscle grade ≥ 3 E: Normal. If sensation and motor function are graded as normal in all segments AND the patient had prior SCI-related deficits |
| Rate & type of complications | within 90 days after treatment initiation | Therapy-Disability-Neurology Grade (TDN Grade) Range: Grade 1-5 The Therapy-Disability-Neurology (TDN) grading system is a novel multidimensional classification of complications severity. higher Grades indicate higher severity of complication |
Countries
Switzerland
Contacts
Primary ContactMartin N. Stienen, PD, MD
Backup ContactFelix C. Stengel, MD
Outcome results
None listed