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CompletedNCT01485458OSCISUpdated Apr 1, 2021

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

An interventional study of Early surgery and Delayed surgery in Spinal Cord Injury, sponsored by Tokyo University. Completed at 1 site in Japan. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2021-04-01.

Sponsored by Tokyo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
20 Years to 79 Years
Sex
All
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Study 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.

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Conditions studied

  • Spinal Cord Injury

Keywords

  • Incomplete spinal cord injury
  • Cervical canal stenosis
  • Ossification of the posterior longitudinal ligament
  • Surgery
  • Decompression
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In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's enrollment of 72 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

Tokyo University is the lead sponsor of 34 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Early surgery

    Procedure: Early surgery

  • Active comparator
    Delayed surgery

    Procedure: Delayed surgery

Interventions

  • ProcedureEarly surgery

    Surgery within 24 hours after admission

  • ProcedureDelayed surgery

    Surgery more than 2 weeks after injury

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What researchers measure

Primary outcomes

  1. ASIA motor score

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

    Time frame: baseline and one year

  2. the ability to walk without assistance

    proportion of patients who regained the ability to walk without assistance

    Time frame: one year

  3. Spinal Cord Independence Measure (SCIM)

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

    Time frame: one year

Secondary outcomes

  1. Health-related quality of life

    SF-36 EQ-5D

    Time frame: one year

  2. Neuropathic pain

    Neuropathic Pain Symptom Inventory

    Time frame: one year

  3. Walking status

    Walking Index for Spinal Cord Injury (WISCI) II

    Time frame: one year

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Study locations

1 site
  • The University of Tokyo
    Tokyo, Japan
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References and documents

Publications

  • OSCIS investigators; Chikuda H, Koyama Y, Matsubayashi Y, Ogata T, Ohtsu H, Sugita S, Sumitani M, Kadono Y, Miura T, Tanaka S, Akiyama T, Ando K, Anno M, Azuma S, Endo K, Endo T, Fujiyoshi T, Furuya T, Hayashi H, Higashikawa A, Hiyama A, Horii C, Iimoto S, Iizuka Y, Ikuma H, Imagama S, Inokuchi K, Inoue H, Inoue T, Ishii K, Ishii M, Ito T, Itoi A, Iwamoto K, Iwasaki M, Kaito T, Kato T, Katoh H, Kawaguchi Y, Kawano O, Kimura A, Kobayashi K, Koda M, Komatsu M, Kumagai G, Maeda T, Makino T, Mannoji C, Masuda K, Masuda K, Matsumoto K, Matsumoto M, Matsunaga S, Matsuyama Y, Mieda T, Miyoshi K, Mochida J, Moridaira H, Motegi H, Nakagawa Y, Nohara Y, Oae K, Ogawa S, Okazaki R, Okuda A, Onishi E, Ono A, Oshima M, Oshita Y, Saita K, Sasao Y, Sato K, Sawakami K, Seichi A, Seki S, Shigematsu H, Suda K, Takagi Y, Takahashi M, Takahashi R, Takasawa E, Takenaka S, Takeshita K, Takeshita Y, Tokioka T, Tokuhashi Y, Tonosu J, Uei H, Wada K, Watanabe M, Yahata T, Yamada K, Yasuda T, Yasui K, Yoshii T. Effect of Early vs Delayed Surgical Treatment on Motor Recovery in Incomplete Cervical Spinal Cord Injury With Preexisting Cervical Stenosis: A Randomized Clinical Trial. JAMA Netw Open. 2021 Nov 1;4(11):e2133604. doi: 10.1001/jamanetworkopen.2021.33604. Erratum In: JAMA Netw Open. 2021 Dec 1;4(12):e2143306. doi: 10.1001/jamanetworkopen.2021.43306. PubMed 34751757 ↗
  • Chikuda H, Ohtsu H, Ogata T, Sugita S, Sumitani M, Koyama Y, Matsumoto M, Toyama Y; OSCIS investigators. Optimal treatment for spinal cord injury associated with cervical canal stenosis (OSCIS): a study protocol for a randomized controlled trial comparing early versus delayed surgery. Trials. 2013 Aug 7;14:245. doi: 10.1186/1745-6215-14-245. PubMed 23924165 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01485458
Lead sponsor
Tokyo University
Responsible party
Hirotaka Chikuda (Lecturer, Tokyo University) — Principal investigator
First posted
Dec 5, 2011
Start date
Dec 2011
Primary completion
Dec 2019
Completion
Dec 2020
Last update
Apr 1, 2021

Study contacts

Hirotaka Chikuda, MD, PhD
principal investigator · Tokyo University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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