Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 22 for:    aospine

Surgical Treatment for Spinal Cord Injury (SCI-POEM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01674764
Recruitment Status : Recruiting
First Posted : August 29, 2012
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
AOSpine Europe

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.

Condition or disease Intervention/treatment
Acute Spinal Cord Injury of Traumatic Origin (tSCI) Procedure: Early surgical intervention Procedure: Late surgical intervention

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : November 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Early surgical intervention = Cohort 1
≤ 12 hours after the tSCI
Procedure: Early surgical intervention
Open surgical stabilization and decompression (anterior, posterior or circumferential); and/or Closed reduction and external fixation
Other Name: ≤ 12 hours after the tSCI

Late surgical intervention = Cohort 2
> 12 hours and < 14 days after the tSCI
Procedure: Late surgical intervention
Open surgical stabilization and decompression (anterior, posterior or circumferential); and/or Closed reduction and external fixation
Other Name: > 12 hours and < 14 days after the tSCI




Primary Outcome Measures :
  1. Change in American Spinal Injury Association Lower Extremities Motor Score (ASIALEMS) between pre-surgery and 1-year post-surgery FU [ Time Frame: Between pre-surgery and 1-year post-surgery ]

Secondary Outcome Measures :
  1. Change in American Spinal Injury Association Motor Score (ASIAMS) between pre-surgery and 1-year FU [ Time Frame: Pre-surgery and 1-year FU ]
  2. Change in American Spinal Injury Association Upper Extremities Motor Score (ASIAUEMS) between pre-surgery and 1-year FU [ Time Frame: Between pre-surgery and 1-year FU ]
  3. Change in American Spinal Injury Association Impairment Scale (AIS) between pre-surgery and 1-year FU [ Time Frame: Between pre-surgery and 1-year FU ]
  4. Change in American Spinal Injury Association Sensory Score (ASIASS) between pre-surgery and 1-year FU [ Time Frame: Between pre-surgery and 1-year FU ]
  5. Spinal Cord Independency Measure (SCIM) at the 6-month and 1-year FU [ Time Frame: 6-month and 1-year FU ]
  6. 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 [ Time Frame: Pre-injury and 1-year FU ]
  7. Rate of treatment related adverse events, as assessed by an independent evaluator [ Time Frame: Until the 1-year FU ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01674764


Contacts
Layout table for location contacts
Contact: Brigitte Gallo +41 44 200 24 06 brigitte.gallo@aofoundation.org
Contact: Joffrey Baczkowski +41 44 200 24 66 benjamin.weiss@aofoundation.org

Locations
Show Show 17 study locations
Sponsors and Collaborators
AOSpine Europe
Investigators
Layout table for investigator information
Principal Investigator: Allard JF Hosman, MD, PhD Medical Co-Director Spine Unit, Radboud University Medical Centre, 6500 Nijmegen, The Netherlands

Layout table for additonal information
Responsible Party: AOSpine Europe
ClinicalTrials.gov Identifier: NCT01674764    
Other Study ID Numbers: SCI-POEM
First Posted: August 29, 2012    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System