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

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Trial of Early Versus Delayed Surgery for Acute Traumatic Cervical Spinal Cord Injury Without Bone Injury in Patients With Cervical Canal Stenosis

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Procedure: Early surgery
* Procedure: Delayed surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with acute traumatic cervical spinal cord injury (at C5 or below) admitted within 48 hours after injury No bone injury (no fracture or instability) American Spinal Injury Association (ASIA) Impairment Grade C Cervical canal stenosis due to preexisting conditions such as spondylosis and ossification of the posterior longitudinal ligament (OPLL) Exclusion Criteria: Unstable medical status Difficult to undergo surgery within 24 hours after admission Impaired consciousness or mental disorder that precludes neurological examination Difficult to obtain informed consent in Japanese

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early surgery<br> | Procedure: Early surgery<br>* Surgery within 24 hours after admission<br>|
| Active Comparator: Delayed surgery<br> | Procedure: Delayed surgery<br>* Surgery more than 2 weeks after injury<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASIA motor score | change from baseline to one year in the American Spinal Injury Association (ASIA) motor score | baseline and one year | 
| the ability to walk without assistance | proportion of patients who regained the ability to walk without assistance | one year | 
| Spinal Cord Independence Measure (SCIM) | the total score of the Spinal Cord Independence Measure (SCIM) version 3 | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life | SF-36 EQ-5D | one year | 
| Neuropathic pain | Neuropathic Pain Symptom Inventory | one year | 
| Walking status | Walking Index for Spinal Cord Injury (WISCI) II | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incomplete spinal cord injury, Cervical canal stenosis, Ossification of the posterior longitudinal ligament, Surgery, Decompression