Clinical trial NCT01674764: Surgical Treatment for Spinal Cord Injury
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Spinal Cord Injury of Traumatic Origin (tSCI)
Lead sponsor: AOSpine Europe
Sponsor class: INDUSTRY
First posted: 2012-08-29
Enrollment: 297
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Change in American Spinal Injury Association Lower Extremities Motor Score (ASIALEMS) between pre-surgery and 1-year post-surgery FU
timeFrame: Between pre-surgery and 1-year post-surgery
Secondary outcomes:
measure: Change in American Spinal Injury Association Motor Score (ASIAMS) between pre-surgery and 1-year FU
timeFrame: Pre-surgery and 1-year FU
measure: Change in American Spinal Injury Association Upper Extremities Motor Score (ASIAUEMS) between pre-surgery and 1-year FU
timeFrame: Between pre-surgery and 1-year FU
measure: Change in American Spinal Injury Association Impairment Scale (AIS) between pre-surgery and 1-year FU
timeFrame: Between pre-surgery and 1-year FU
measure: Change in American Spinal Injury Association Sensory Score (ASIASS) between pre-surgery and 1-year FU
timeFrame: Between pre-surgery and 1-year FU
measure: Spinal Cord Independency Measure (SCIM) at the 6-month and 1-year FU
timeFrame: 6-month and 1-year FU
measure: 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
timeFrame: Pre-injury and 1-year FU
measure: Rate of treatment related adverse events, as assessed by an independent evaluator
timeFrame: Until the 1-year FU
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
city: Sofia
country: Bulgaria
facility: National Institute of Emergency Medicine "N.I. Pirogov"
city: Zagreb
country: Croatia
facility: Teaching Hospital Sisiters of Charity
city: Lyon
country: France
facility: Hôspital P. Wertheimer
city: Frankfurt
country: Germany
facility: BG Unfallklinik Frankfurt
city: Ludwigshafen
country: Germany
facility: Berufsgenossenschaftliche Unfallklinik Ludwigshafen
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Bologna
country: Italy
facility: Ospedale Maggiore
city: Rom
country: Italy
facility: Policlinico Umberto Primo
city: Nijmegen
country: Netherlands
facility: University Medical Center St. Radboud
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Iasi
country: Romania
facility: Spitalul "Sfanta Treime"
city: Novi Sad
country: Serbia
facility: Clinical Center Vojvodina
city: Ankara
country: Turkey
facility: Gazi University Faculty of Medicine
city: London
country: United Kingdom
facility: King's College Hospital
city: Nottingham
country: United Kingdom
facility: Queens's Medical Centre Campus
city: Oxford
country: United Kingdom
facility: Nuffield Orthopaedic Centre Headington
Study officials:
affiliation: Medical Co-Director Spine Unit, Radboud University Medical Centre, 6500 Nijmegen, The Netherlands
name: Allard JF Hosman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: