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

Spinal Cord Injury Clinical Trial

— OSCIS  

Official title:

Randomized Trial of Early Versus Delayed Surgery for Acute Traumatic Cervical Spinal Cord Injury Without Bone Injury in Patients With Cervical Canal Stenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01485458
• Other study ID #: OSCIS
• Secondary ID: UMIN000006780
• Status: Completed
• Phase: N/A
• Start date: December 2011
• Est. completion date: December 2020

Study information

• Verified date: March 2021
• Source: Tokyo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Procedure:
• Early surgery
Surgery within 24 hours after admission
• Delayed surgery
Surgery more than 2 weeks after injury

Locations

Country	Name	City	State
Japan	The University of Tokyo	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Tokyo University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ASIA motor score	change from baseline to one year in the American Spinal Injury Association (ASIA) motor score	baseline and one year
Primary	the ability to walk without assistance	proportion of patients who regained the ability to walk without assistance	one year
Primary	Spinal Cord Independence Measure (SCIM)	the total score of the Spinal Cord Independence Measure (SCIM) version 3	one year
Secondary	Health-related quality of life	SF-36 EQ-5D	one year
Secondary	Neuropathic pain	Neuropathic Pain Symptom Inventory	one year
Secondary	Walking status	Walking Index for Spinal Cord Injury (WISCI) II	one year