Acute Spinal Cord Injury of Traumatic Origin (tSCI) Clinical Trial
— SCI-POEMOfficial title:
Prognostic Factors and Therapeutic Effects of Surgical Treatment for Traumatic Spinal Column Injury With Spinal Cord Injury: A Prospective, Observational European Multi-center Study.
| NCT number | NCT01674764 |
| Other study ID # | SCI-POEM |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 2012 |
| Est. completion date | October 2019 |
| Verified date | May 2020 |
| Source | AOSpine Europe |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Despite many years of research, an incomprehensible amount of scientific efforts worldwide and billions of dollars invested, no effective therapy resulting in major neurological or functional recovery is available to date for traumatic spinal cord injury (tSCI). Although there is increasing experimental evidence from animal models that surgical decompression of the spinal cord improves recovery after tSCI, clinical studies have not shown conclusive data yet. The main explanations for this lack of convincing evidence are relatively small sample sizes in previous studies, their predominantly retrospective nature, suboptimal measurement methods for the assessment of neurological deficits, and inappropriate recording and documentation of potential confounding factors.
| Status | Completed |
| Enrollment | 297 |
| Est. completion date | October 2019 |
| Est. primary completion date | October 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medical University Innsbruck | Innsbruck | |
| Bulgaria | National Institute of Emergency Medicine "N.I. Pirogov" | Sofia | |
| Croatia | Teaching Hospital Sisiters of Charity | Zagreb | |
| France | Hôspital P. Wertheimer | Lyon | |
| Germany | BG Unfallklinik Frankfurt | Frankfurt | |
| Germany | Berufsgenossenschaftliche Unfallklinik Ludwigshafen | Ludwigshafen | |
| Ireland | Mater Misericordiae University Hospital | Dublin | |
| Italy | Ospedale Maggiore | Bologna | |
| Italy | Policlinico Umberto Primo | Rom | |
| Netherlands | University Medical Center St. Radboud | Nijmegen | |
| Netherlands | University Medical Center Utrecht | Utrecht | |
| Romania | Spitalul "Sfanta Treime" | Iasi | |
| Serbia | Clinical Center Vojvodina | Novi Sad | |
| Turkey | Gazi University Faculty of Medicine | Ankara | |
| United Kingdom | King`s College Hospital | London | |
| United Kingdom | Queens`s Medical Centre Campus | Nottingham | |
| United Kingdom | Nuffield Orthopaedic Centre Headington | Oxford |
| Lead Sponsor | Collaborator |
|---|---|
| AOSpine Europe |
Austria, Bulgaria, Croatia, France, Germany, Ireland, Italy, Netherlands, Romania, Serbia, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in American Spinal Injury Association Lower Extremities Motor Score (ASIALEMS) between pre-surgery and 1-year post-surgery FU | Between pre-surgery and 1-year post-surgery | ||
| Secondary | Change in American Spinal Injury Association Motor Score (ASIAMS) between pre-surgery and 1-year FU | Pre-surgery and 1-year FU | ||
| Secondary | Change in American Spinal Injury Association Upper Extremities Motor Score (ASIAUEMS) between pre-surgery and 1-year FU | Between pre-surgery and 1-year FU | ||
| Secondary | Change in American Spinal Injury Association Impairment Scale (AIS) between pre-surgery and 1-year FU | Between pre-surgery and 1-year FU | ||
| Secondary | Change in American Spinal Injury Association Sensory Score (ASIASS) between pre-surgery and 1-year FU | Between pre-surgery and 1-year FU | ||
| Secondary | Spinal Cord Independency Measure (SCIM) at the 6-month and 1-year FU | 6-month and 1-year FU | ||
| Secondary | Change in quality of life using the Short version of the World Health Organization Quality-of-Life questionnaire (WHOQOL-BREF) between pre-injury and 1-year FU | Pre-injury and 1-year FU | ||
| Secondary | Rate of treatment related adverse events, as assessed by an independent evaluator | Until the 1-year FU |