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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006780
Receipt No. R000008009
Scientific Title Randomized trial of early versus delayed surgery for acute traumatic cervical spinal cord injury without bone injury in patients with cervical canal stenosis
Date of disclosure of the study information 2011/12/01
Last modified on 2019/06/04

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Basic information
Public 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 Optimal treatment for spinal cord injury associated with cervical canal stenosis (OSCIS) study
Scientific Title Randomized trial of early versus delayed surgery for acute traumatic cervical spinal cord injury without bone injury in patients with cervical canal stenosis
Scientific Title:Acronym Optimal treatment for spinal cord injury associated with cervical canal stenosis (OSCIS) study
Region
Japan

Condition
Condition Acute traumatic cervical spinal cord injury without bone injury
Classification by specialty
Orthopedics Neurosurgery Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To test the hypothesis that early surgery would result in increased improvement in motor function as compared with delayed surgery in patients with acute traumatic cervical spinal cord injury without bone injury
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Recovery of motor function at one year after injury

1) the change from baseline to 1 year in the ASIA motor score
2) rate of patients who regained the ability to walk without assistance
3) total score of the Spinal Cord Independence Measure (SCIM) at 1 year after injury
Key secondary outcomes Walking Index for Spinal Cord Injury(WISCI) II
SF36
EQ-5D
Neuropathic Pain Symptom Inventory

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Surgery within 24 hours after admission
Interventions/Control_2 Surgery more than 2 weeks after injury
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients with acute traumatic cervical cord injury (at C5 or below) admitted within 48 hours after injury

1) No bone injury
2) ASIA (American Spinal Injury Association) Impairment Grade C
3) Cervical canal stenosis due to preexisting conditions such as spondylosis and ossification of posterior longitudinal ligament (OPLL)
Key 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

Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirotaka Chikuda
Organization The Univerisity of Tokyo
Division name Dept. of Orthopaedic Surgery
Zip code
Address Hongo 7-3-1, Bunkyo-ku, Tokyo 113-0033, Japan
TEL 03-3815-5411
Email oscis-core@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirotaka Chikuda
Organization The Univerisity of Tokyo
Division name Dept. of Orthopaedic Surgery
Zip code
Address Hongo 7-3-1, Bunkyo-ku, Tokyo 113-0033, Japan
TEL 03-3815-5411
Homepage URL
Email oscis-core@umin.ac.jp

Sponsor
Institute The Univerisity of Tokyo
Institute
Department

Funding Source
Organization Committee for Study of Ossification of Spinal Ligaments, Ministry of Health, Labour, and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT01485458
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京大学医学部整形外科(東京都)
大阪大学大学院医学系研究科器官制御外科学(整形外科)(大阪府)
星ヶ丘厚生年金病院(大阪府)
国立病院機構大阪南医療センター(大阪府)
都立墨東病院救急救命センター(東京都)
都立多摩総合医療センター(東京都)
自治医科大学さいたま医療センター(埼玉県)
埼玉医科大学総合医療センター(埼玉県)
倉敷中央病院(岡山県)
和歌山県立医科大学(和歌山県)
今給黎総合病院(鹿児島県)
日本大学医学部(東京都)
自治医科大学(栃木県)
関東労災病院(神奈川県)
関西労災病院(兵庫県)
北海道中央労災病院せき損センター(北海道)
名古屋大学(愛知県)
久留米大学(福岡県)
浜松医科大学(静岡県)
聖マリアンナ医科大学(神奈川県)
杏林大学(東京都)
富山大学(富山県
鹿児島大学(鹿児島県)
国立病院機構仙台医療センター(宮城県)
獨協医科大学(栃木県)
慶應大学(東京都)
東京医科歯科大学(東京都)
新潟市民病院(新潟県)
千葉市立青葉病院(千葉県)
順天堂大学医学部附属静岡病院(静岡県)
横浜労災病院(神奈川県)
神戸市立医療センター中央市民病院(兵庫県)
君津中央病院(千葉県)
千葉大学(千葉県)
東海大学(神奈川県)
総合せき損センター(福岡県)
弘前大学(青森県)
高知医療センター(高知県)
奈良県立医科大学(奈良県)
昭和大学横浜市北部病院(神奈川県)
さいたま赤十字病院(埼玉県)
市立砺波総合病院(富山県)

Other administrative information
Date of disclosure of the study information
2011 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2011 Year 06 Month 23 Day
Date of IRB
2017 Year 04 Month 10 Day
Anticipated trial start date
2011 Year 12 Month 01 Day
Last follow-up date
2019 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 11 Month 28 Day
Last modified on
2019 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008009

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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