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Trial record 1 of 1 for:    NCT01485458
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Optimal Treatment for Spinal Cord Injury Associated With Cervical Canal Stenosis (OSCIS) Study (OSCIS)

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. Read our disclaimer for details. Identifier: NCT01485458
Recruitment Status : Active, not recruiting
First Posted : December 5, 2011
Last Update Posted : March 13, 2020
Information provided by (Responsible Party):
Hirotaka Chikuda, Tokyo University

Brief Summary:
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 or disease Intervention/treatment Phase
Spinal Cord Injury Procedure: Early surgery Procedure: Delayed surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
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
Study Start Date : December 2011
Actual Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. ASIA motor score [ Time Frame: baseline and one year ]
    change from baseline to one year in the American Spinal Injury Association (ASIA) motor score

  2. the ability to walk without assistance [ Time Frame: one year ]
    proportion of patients who regained the ability to walk without assistance

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

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01485458

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The University of Tokyo
Tokyo, Japan
Sponsors and Collaborators
Tokyo University
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Principal Investigator: Hirotaka Chikuda, MD, PhD Tokyo University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hirotaka Chikuda, Lecturer, Tokyo University Identifier: NCT01485458    
Other Study ID Numbers: OSCIS
UMIN000006780 ( Registry Identifier: UMIN-CTR )
First Posted: December 5, 2011    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hirotaka Chikuda, Tokyo University:
Incomplete spinal cord injury
Cervical canal stenosis
Ossification of the posterior longitudinal ligament
Additional relevant MeSH terms:
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Spinal Cord Injuries
Constriction, Pathologic
Wounds and Injuries
Pathological Conditions, Anatomical
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System