Randomized trial of early versus delayed surgery for acute traumatic cervical spinal cord injury without bone injury in patients with cervical canal stenosis
Phase 2
- Conditions
- Acute traumatic cervical spinal cord injury without bone injury
- Registration Number
- JPRN-UMIN000006780
- Lead Sponsor
- The Univerisity of Tokyo
- Brief Summary
The results of this trial suggest that among patients with cervical SCI, early surgical treatment produced similar motor regain at 1 year after injury as delayed surgical treatment but showed accelerated recovery within the first 6 months. These exploratory results suggest that early surgical treatment leads to faster neurological recovery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recovery of motor function at one year after injury 1) the change from baseline to 1 year in the ASIA motor score 2) rate of patients who regained the ability to walk without assistance 3) total score of the Spinal Cord Independence Measure (SCIM) at 1 year after injury
- Secondary Outcome Measures
Name Time Method Walking Index for Spinal Cord Injury(WISCI) II SF36 EQ-5D Neuropathic Pain Symptom Inventory