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Optimal Treatment for Spinal Cord Injury Associated With Cervical Canal Stenosis (OSCIS) Study

This study is currently recruiting participants.
Verified December 2011 by Tokyo University
Sponsor:
Information provided by (Responsible Party):
Tokyo University
ClinicalTrials.gov Identifier:
NCT01485458
First received: November 30, 2011
Last updated: December 3, 2011
Last verified: December 2011
History of Changes
  Purpose

Controversy exists regarding the optimal management of acute traumatic cervical spinal cord injury (SCI), especially those without bone injury. Although surgical decompression is often performed in SCI patients with cervical canal stenosis, efficacy and timing of surgery continues to be a subject of intense debate. In this randomized controlled trial, the investigators compare two strategies: early surgery within 24 hours after admission and delayed surgery following at least 2 weeks of conservative treatment. The purpose of this study is to examine whether early surgery would result in greater improvement in motor function as compared with delayed surgery.


Condition Intervention Phase
Spinal Cord Injury
 Procedure: Early surgery
Procedure: Delayed surgery
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial of Early Versus Delayed Surgery for Acute Traumatic Cervical Spinal Cord Injury Without Bone Injury in Patients With Cervical Canal Stenosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tokyo University:

Primary Outcome Measures:
  • ASIA motor score [ Time Frame: baseline and one year ] [ Designated as safety issue: No ]
    change from baseline to one year in the American Spinal Injury Association (ASIA) motor score

  • the ability to walk without assistance [ Time Frame: one year ] [ Designated as safety issue: No ]
    proportion of patients who regained the ability to walk without assistance

  • Spinal Cord Independence Measure (SCIM) [ Time Frame: one year ] [ Designated as safety issue: No ]
    the total score of the Spinal Cord Independence Measure (SCIM) version 3


Secondary Outcome Measures:
  • Health-related quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]
    SF-36 EQ-5D

  • Neuropathic pain [ Time Frame: one year ] [ Designated as safety issue: No ]
    Neuropathic Pain Symptom Inventory

  • Walking status [ Time Frame: one year ] [ Designated as safety issue: No ]
    Walking Index for Spinal Cord Injury (WISCI) II


Estimated Enrollment: 100
Study Start Date: December 2011
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early surgery Procedure: Early surgery
Surgery within 24 hours after admission
Active Comparator: Delayed surgery Procedure: Delayed surgery
Surgery more than 2 weeks after injury

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with acute traumatic cervical spinal cord injury (at C5 or below) admitted within 48 hours after injury

    1. No bone injury (no fracture or instability)
    2. American Spinal Injury Association (ASIA) Impairment Grade C
    3. Cervical canal stenosis due to preexisting conditions such as spondylosis and ossification of the posterior longitudinal ligament (OPLL)

Exclusion Criteria:

  1. Unstable medical status
  2. Difficult to undergo surgery within 24 hours after admission
  3. Impaired consciousness or mental disorder that precludes neurological examination
  4. Difficult to obtain informed consent in Japanese
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485458

Contacts
Contact: Hirotaka Chikuda, MD, PhD +81-3-3815-5411 ext 33376 oscis-core@umin.ac.jp

Locations
Japan
The University of Tokyo Recruiting
Tokyo, Japan
Contact: Hirotaka Chikuda, MD, PhD     +81-3-3815-5411 ext 33376     oscis-core@umin.ac.jp    
Sponsors and Collaborators
Tokyo University
Investigators
Principal Investigator: Hirotaka Chikuda, MD, PhD The University of Tokyo
  More Information

No publications provided

Responsible Party: Tokyo University
ClinicalTrials.gov Identifier: NCT01485458     History of Changes
Other Study ID Numbers: OSCIS, UMIN000006780
Study First Received: November 30, 2011
Last Updated: December 3, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Tokyo University:
Incomplete spinal cord injury
Cervical canal stenosis
Ossification of the posterior longitudinal ligament
Surgery
Decompression

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 19, 2013