MedTrace Logo

Surgical Treatment for Spinal Cord Injury

NCT01674764 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 297

Last updated 2020-05-13

No results posted yet for this study

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)

Interventions

PROCEDURE

Early surgical intervention

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

PROCEDURE

Late surgical intervention

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

Sponsors & Collaborators

  • AOSpine Europe

    lead INDUSTRY

Principal Investigators

  • Allard JF Hosman, MD, PhD · Medical Co-Director Spine Unit, Radboud University Medical Centre, 6500 Nijmegen, The Netherlands

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2019-10-31
Completion
2019-10-31

Countries

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

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01674764 on ClinicalTrials.gov