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

Tokyo University

Status

Completed

Conditions

Spinal Cord Injury

Treatments

Procedure: Early surgery

Procedure: Delayed surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT01485458

OSCIS

UMIN000006780 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

20 to 79 years old

Volunteers

No Healthy Volunteers

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

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