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

NCT01485458 | Completed DMC

• 2 other identifiers: OSCISUMIN000006780
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

Incomplete spinal cord injury; Cervical canal stenosis; Ossification of the posterior longitudinal ligament; Surgery; Decompression

Outcome Measures

Primary Outcomes (3)

• ASIA motor score

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

  baseline and one year

• the ability to walk without assistance

  proportion of patients who regained the ability to walk without assistance

  one year

• Spinal Cord Independence Measure (SCIM)

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

  one year

Secondary Outcomes (3)

• Health-related quality of life

  one year

• Neuropathic pain

  one year

• Walking status

  one year

Study Arms (2)

Early surgery

EXPERIMENTAL

Procedure: Early surgery

Delayed surgery

ACTIVE COMPARATOR

Procedure: Delayed surgery

Interventions

Early surgery PROCEDURE

Surgery within 24 hours after admission

Early surgery

Delayed surgery PROCEDURE

Surgery more than 2 weeks after injury

Delayed surgery

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tokyo University: lead

Study Sites (1)

The University of Tokyo

Tokyo, Japan

Location

Related Publications (2)

• 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.

  PMID: 34751757 DERIVED

• 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.

  PMID: 23924165 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Ossification of Posterior Longitudinal Ligament

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ossification, Heterotopic; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hirotaka Chikuda, MD, PhD

  Tokyo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 30, 2011
• First Posted: December 5, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)