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NCT Number: NCT01485458

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

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.

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Key information

Conditions

Spinal Cord Injury Bone Diseases Central Nervous System Diseases Musculoskeletal Diseases Nervous System Diseases Ossification of Posterior Longitudinal Ligament Ossification, Heterotopic Pathologic Processes Pathological Conditions, Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Spinal Diseases Trauma, Nervous System Wounds and Injuries

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Tokyo

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with acute traumatic cervical spinal cord injury (at C5 or below) admitted within 48 hours after injury
  • 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

Treatment and study plan

Early Surgery

Procedure

Surgery within 24 hours after admission

Delayed surgery

Procedure

Surgery more than 2 weeks after injury

Primary outcomes

  1. ASIA motor score

    Time frame: baseline and one year

    change from baseline to one year in the American Spinal Injury Association (ASIA) motor score

  2. the ability to walk without assistance

    Time frame: one year

    proportion of patients who regained the ability to walk without assistance

  3. Spinal Cord Independence Measure (SCIM)

    Time frame: one year

    the total score of the Spinal Cord Independence Measure (SCIM) version 3

Secondary outcomes

  1. Health-related quality of life

    Time frame: one year

    SF-36 EQ-5D

  2. Neuropathic pain

    Time frame: one year

    Neuropathic Pain Symptom Inventory

  3. Walking status

    Time frame: one year

    Walking Index for Spinal Cord Injury (WISCI) II

Sponsors and collaborators

Lead sponsor

Tokyo University

Other

Registry information

Official study title

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

Acronym: OSCIS

Important dates

Study start
2011
Primary completion
2019
Study completion
2020
First posted
Dec 5, 2011
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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