Surgical Treatment for Spinal Cord Injury

NCT ID: NCT01674764

Last Updated: 2020-05-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 297 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2019-10-31

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.

Conditions

Acute Spinal Cord Injury of Traumatic Origin (tSCI)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Early surgical intervention = Cohort 1

≤ 12 hours after the tSCI

Early surgical intervention

Intervention Type: PROCEDURE

Open surgical stabilization and decompression (anterior, posterior or circumferential); and/or Closed reduction and external fixation

Late surgical intervention = Cohort 2

\> 12 hours and \< 14 days after the tSCI

Late surgical intervention

Intervention Type: PROCEDURE

Open surgical stabilization and decompression (anterior, posterior or circumferential); and/or Closed reduction and external fixation

Interventions

Early surgical intervention

Open surgical stabilization and decompression (anterior, posterior or circumferential); and/or Closed reduction and external fixation

Intervention Type: PROCEDURE

Late surgical intervention

Open surgical stabilization and decompression (anterior, posterior or circumferential); and/or Closed reduction and external fixation

Intervention Type: PROCEDURE

Other Intervention Names

≤ 12 hours after the tSCI; > 12 hours and < 14 days after the tSCI

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AOSpine Europe

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allard JF Hosman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Co-Director Spine Unit, Radboud University Medical Centre, 6500 Nijmegen, The Netherlands

Locations

Medical University Innsbruck

Innsbruck, , Austria

National Institute of Emergency Medicine "N.I. Pirogov"

Sofia, , Bulgaria

Teaching Hospital Sisiters of Charity

Zagreb, , Croatia

Hôspital P. Wertheimer

Lyon, , France

BG Unfallklinik Frankfurt

Frankfurt, , Germany

Berufsgenossenschaftliche Unfallklinik Ludwigshafen

Ludwigshafen, , Germany

Mater Misericordiae University Hospital

Dublin, , Ireland

Ospedale Maggiore

Bologna, , Italy

Policlinico Umberto Primo

Rome, , Italy

University Medical Center St. Radboud

Nijmegen, , Netherlands

University Medical Center Utrecht

Utrecht, , Netherlands

Spitalul "Sfanta Treime"

Iași, , Romania

Clinical Center Vojvodina

Novi Sad, , Serbia

Gazi University Faculty of Medicine

Ankara, , Turkey (Türkiye)

King's College Hospital

London, , United Kingdom

Queens's Medical Centre Campus

Nottingham, , United Kingdom

Nuffield Orthopaedic Centre Headington

Oxford, , United Kingdom

Countries

Austria; Bulgaria; Croatia; France; Germany; Ireland; Italy; Netherlands; Romania; Serbia; Turkey (Türkiye); United Kingdom

Other Identifiers

SCI-POEM

Identifier Type: -

Identifier Source: org_study_id