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

This study is currently recruiting participants.
Verified April 2017 by Hirotaka Chikuda, Tokyo University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01485458
First Posted: December 5, 2011
Last Update Posted: April 27, 2017
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.
Information provided by (Responsible Party):
Hirotaka Chikuda, Tokyo University
  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
Spinal Cord Injury Procedure: Early surgery Procedure: Delayed surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Hirotaka Chikuda, Tokyo University:

Primary Outcome Measures:
  • ASIA motor score [ Time Frame: baseline and one year ]
    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 ]
    proportion of patients who regained the ability to walk without assistance

  • Spinal Cord Independence Measure (SCIM) [ Time Frame: one year ]
    the total score of the Spinal Cord Independence Measure (SCIM) version 3


Secondary Outcome Measures:
  • Health-related quality of life [ Time Frame: one year ]
    SF-36 EQ-5D

  • Neuropathic pain [ Time Frame: one year ]
    Neuropathic Pain Symptom Inventory

  • Walking status [ Time Frame: one year ]
    Walking Index for Spinal Cord Injury (WISCI) II


Estimated Enrollment: 100
Study Start Date: December 2011
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2019 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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 Tokyo University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hirotaka Chikuda, Lecturer, Tokyo University
ClinicalTrials.gov Identifier: NCT01485458     History of Changes
Other Study ID Numbers: OSCIS
UMIN000006780 ( Registry Identifier: UMIN-CTR )
First Submitted: November 30, 2011
First Posted: December 5, 2011
Last Update Posted: April 27, 2017
Last Verified: April 2017

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

Additional relevant MeSH terms:
Wounds and Injuries
Constriction, Pathologic
Spinal Cord Injuries
Pathological Conditions, Anatomical
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System