Surgical Treatment for Spinal Cord Injury

NCT01674764 | Completed DMC

• 1 other identifier: SCI-POEM
• Study Type: observational
• Target: 297
• Locations: 12 countries
• Sites: 17

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.

Conditions

Acute Spinal Cord Injury of Traumatic Origin (tSCI)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in American Spinal Injury Association Motor Score (ASIAMS) between pre-surgery and 1-year FU

  Pre-surgery and 1-year FU

• 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

• Change in American Spinal Injury Association Impairment Scale (AIS) between pre-surgery and 1-year FU

  Between pre-surgery and 1-year FU

• Change in American Spinal Injury Association Sensory Score (ASIASS) between pre-surgery and 1-year FU

  Between pre-surgery and 1-year FU

• Spinal Cord Independency Measure (SCIM) at the 6-month and 1-year FU

  6-month and 1-year FU

Study Arms (2)

Early surgical intervention = Cohort 1

≤ 12 hours after the tSCI

Procedure: Early surgical intervention

Late surgical intervention = Cohort 2

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

Procedure: Late surgical intervention

Interventions

Early surgical intervention PROCEDURE

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

Also known as: ≤ 12 hours after the tSCI

Early surgical intervention = Cohort 1

Late surgical intervention PROCEDURE

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

Also known as: > 12 hours and < 14 days after the tSCI

Late surgical intervention = Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• Prisoner
• Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Sponsors & Collaborators

• AOSpine Europe: lead

Study Sites (17)

Medical University Innsbruck

Innsbruck, 6020, Austria

Location

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

Sofia, 1606, Bulgaria

Location

Teaching Hospital Sisiters of Charity

Zagreb, 10000, Croatia

Location

Hôspital P. Wertheimer

Lyon, 69500, France

Location

BG Unfallklinik Frankfurt

Frankfurt, 60389, Germany

Location

Berufsgenossenschaftliche Unfallklinik Ludwigshafen

Ludwigshafen, 67071, Germany

Location

Mater Misericordiae University Hospital

Dublin, Ireland

Location

Ospedale Maggiore

Bologna, 40133, Italy

Location

Policlinico Umberto Primo

Rome, 00161, Italy

Location

University Medical Center St. Radboud

Nijmegen, 6500 HB, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3508 GA, Netherlands

Location

Spitalul "Sfanta Treime"

Iași, Romania

Location

Clinical Center Vojvodina

Novi Sad, 21000, Serbia

Location

Gazi University Faculty of Medicine

Ankara, 06000, Turkey (Türkiye)

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Queens's Medical Centre Campus

Nottingham, NG7 2UH, United Kingdom

Location

Nuffield Orthopaedic Centre Headington

Oxford, OX3 7LD, United Kingdom

Location

Related Publications (1)

• Romijn P, Kussige PGP, van Hooff ML, Evaniew N, van de Meent H, van Middendorp JJ, Pouw MH, Hosman AJF. Early versus late surgical decompression in acute traumatic spinal cord injury: does it impact the quality of life? Spinal Cord. 2025 Dec 27. doi: 10.1038/s41393-025-01165-y. Online ahead of print.

  PMID: 41455816 DERIVED

Study Officials

• Allard JF Hosman, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2012
• First Posted: August 29, 2012
• Study Start: November 1, 2012
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: May 13, 2020

Record last verified: 2020-05

Locations

CR (1); DE (2); IT (2); TU (1); SE (1); BU (1); IE (1); NL (2); GB (3); RO (1); AU (1); FR (1)