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

Not Applicable

Completed

• Conditions: Spinal Cord Injury
• Interventions: Procedure: Delayed surgery; Procedure: Early surgery

• Registration Number: NCT01485458
• Lead Sponsor: Tokyo University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-30
• Study Start: 2011-12
• Study First Submitted QC: 2011-12-02
• Study First Posted: 2011-12-05
• Primary Completion: 2019-12
• Study Completion: 2020-12
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-29
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed surgery	Delayed surgery	-
Early surgery	Early surgery	-

Primary Outcome Measures

Name	Time	Method
ASIA motor score	baseline and one year	change from baseline to one year in the American Spinal Injury Association (ASIA) motor score
Spinal Cord Independence Measure (SCIM)	one year	the total score of the Spinal Cord Independence Measure (SCIM) version 3
the ability to walk without assistance	one year	proportion of patients who regained the ability to walk without assistance

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The University of Tokyo; 🇯🇵 Tokyo, Japan