CompletedNot Applicable

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

Japan72 participantsStarted 2011-12

Plain-language 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.

Who can participate

Age range20 Years – 79 Years

SexALL

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Inclusion criteria

✓. 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

What they're measuring

ASIA motor score

Timeframe: baseline and one year

the ability to walk without assistance

Timeframe: one year

Spinal Cord Independence Measure (SCIM)

Timeframe: one year

Trial details

NCT IDNCT01485458

SponsorTokyo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12

View on ClinicalTrials.gov More Spinal Cord Injury trials