Randomized Trial of Early Versus Delayed Surgery for Acute Traumatic Cervical Spinal Cord Injury Without Bone Injury in Patients With Cervical Canal Stenosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Cord Injury
- Sponsor
- Tokyo University
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- ASIA motor score
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Hirotaka Chikuda
Lecturer
Tokyo University
Eligibility Criteria
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
Outcomes
Primary Outcomes
ASIA motor score
Time Frame: baseline and one year
change from baseline to one year in the American Spinal Injury Association (ASIA) motor score
Spinal Cord Independence Measure (SCIM)
Time Frame: one year
the total score of the Spinal Cord Independence Measure (SCIM) version 3
the ability to walk without assistance
Time Frame: one year
proportion of patients who regained the ability to walk without assistance
Secondary Outcomes
- Health-related quality of life(one year)
- Neuropathic pain(one year)
- Walking status(one year)