Spinal Cord Injury
Conditions
Keywords
Incomplete spinal cord injury, Cervical canal stenosis, Ossification of the posterior longitudinal ligament, Surgery, Decompression
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.
Interventions
PROCEDUREEarly surgery
Surgery within 24 hours after admission
PROCEDUREDelayed surgery
Surgery more than 2 weeks after injury
Sponsors
Tokyo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ASIA motor score | 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 | one year | proportion of patients who regained the ability to walk without assistance |
| Spinal Cord Independence Measure (SCIM) | one year | the total score of the Spinal Cord Independence Measure (SCIM) version 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life | one year | SF-36 EQ-5D |
| Neuropathic pain | one year | Neuropathic Pain Symptom Inventory |
| Walking status | one year | Walking Index for Spinal Cord Injury (WISCI) II |
Countries
Japan
Outcome results
None listed