Trials / Completed
CompletedNCT01485458
Optimal Treatment for Spinal Cord Injury Associated With Cervical Canal Stenosis (OSCIS) Study
Randomized Trial of Early Versus Delayed Surgery for Acute Traumatic Cervical Spinal Cord Injury Without Bone Injury in Patients With Cervical Canal Stenosis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Tokyo University · Academic / Other
- Sex
- All
- Age
- 20 Years – 79 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Early surgery | Surgery within 24 hours after admission |
| PROCEDURE | Delayed surgery | Surgery more than 2 weeks after injury |
Timeline
- Start date
- 2011-12-01
- Primary completion
- 2019-12-01
- Completion
- 2020-12-01
- First posted
- 2011-12-05
- Last updated
- 2021-04-01
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT01485458. Inclusion in this directory is not an endorsement.