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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patients admitted to one of the participating centres and treated for ISCM

• Available documentation of admission and postoperative status

Locations
Other Locations
Switzerland
Cantonal Hospital St. Gallen, Neurosurgery
RECRUITING
Sankt Gallen
Contact Information
Primary
Martin N. Stienen, PD, MD
martin.stienen@kssg.ch
+41 71 494 2183
Backup
Felix C. Stengel, MD
felix.stengel@kssg.ch
+41 71 494 2184
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 60
Treatments
iscm_resection
-Adult patients admitted to one of the participating centres and treated for ISCM between 2017 and 2023 by resection of the ISCM with or without adjuvant radiotherapy
iscm_radiotherapy
-Adult patients admitted to one of the participating centres and treated for ISCM between 2017 and 2023 by radiotherapy without resection of the ISCM
Related Therapeutic Areas
Sponsors
Leads: Cantonal Hospital of St. Gallen
Collaborators: Klinikum rechts der Isar Technische Universität München, University Hospital, Geneva, Luzerner Kantonsspital, Stanford University, University Hospital Muenster, University of Toronto, Insel Gruppe AG, University Hospital Bern, Kantonsspital Aarau, Kantonsspital Winterthur KSW, University Hospital, Zürich

This content was sourced from clinicaltrials.gov