SCI-POEMPrognostic Factors and Therapeutic Effects of Surgical Treatment for Traumatic Spinal Column Injury With Spinal Cord Injury: A Prospective, Observational European Multi-center Study.
Procedure Data
+ procedure Data
Collected from today forward - ProspectiveCohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: November 1, 2012
Actual date on which the first participant was enrolled.Although injuries to the spinal column represent a relatively small proportion of all traumatic injuries, spinal injuries have one of the highest impacts on functional outcomes and employment status. Even more than an injury of the spinal column, traumatic spinal cord injury (tSCI) is a devastating disorder severely affecting patients' physical and psychosocial well-being. The incidence of tSCI is estimated to be 11 to 53 new cases per million population per year. This is a multi-center, prospective, observational cohort study to evaluate if early (≤ 12 hours after the tSCI) surgical decom¬pression is superior to late (> 12 hours and < 14 days after the tSCI) in improving neurologic motor outcomes in patients with acute traumatic spinal cord injury. The study will enroll 300 patients with anticipated 1:2 ratio of early vs. late surgery. This CIP is not limited to cervical spinal cord injuries, does not consider a diagnostic MRI as mandatory and will be conducted in a European setting where patients are generally transported more swiftly to the treating institution when compared to other geographic regions in the world. Patients will be evaluated according to the schedule set forth in this CIP. The schedule includes evaluations at pre-surgery, post-surgery, 72 hours post injury, 12 weeks ± 2 weeks; 6 months ± 30 days; 1 year ± 30 days. The enrollment period is expected to be approximately 36 months and subjects will be followed-up for 12 months for the evaluation of the primary endpoint. The study duration is approximately 48 months.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.297 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: Age 18 years and older Diagnosis of blunt spinal column injury and spinal cord injury, including conus medullaris and/or cauda equina injuries Pre-surgery ASIA grade A, B, C or D Less than 14 days between the injury and surgery Ability to understand patient information / informed consent form Willingness and ability to participate in the clinical investigation and FU procedures (FUs) Informed consent according to local legislations and applicable guidelines Exclusion Criteria: Traumatic brain injury: Glasgow Coma Scale (GCS) ≤ 13 Diagnosis of subclinical or clinical polyneuropathy (eg. presence of bilateral impairment of strength, sensation, and/or deep tendon reflexes with symmetrical and distal distribution and/or neurophysiological abnormalities) Spinal cord injury caused by a penetrating injury Non-traumatic or pathologic fractures or cord compression (eg, tumor or infection) Unable to cooperate with physical examination (pre-operative, ≤ 2 weeks) because of cognitive impairment, as assessed by the examiner Previous spinal column or spinal cord injury Diagnosis of spondyloarthropathy (inflammatory or non-inflammatory) Morbid Obesity: Body Mass Index (BMI) > 35 Any severe systemic disease that may have an influence on motor function (eg, polyneuropathy) ASA classification score ≥ 4 Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment Pregnancy at the time of inclusion Prisoner Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 17 locations
National Institute of Emergency Medicine "N.I. Pirogov"
Sofia, BulgariaTeaching Hospital Sisiters of Charity
Zagreb, CroatiaHôspital P. Wertheimer
Lyon, France