UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006780 |
|---|---|
| Receipt number | 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 | 2023/12/07 09:02:11 |
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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 | Hirotaka |
| Middle name | |
| Last name | Chikuda |
Organization
The Univerisity of Tokyo
Division name
Dept. of Orthopaedic Surgery
Zip code
113-0033
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo 113-0033, Japan
TEL
03-3815-5411
oscis-core@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Chikuda |
Organization
The Univerisity of Tokyo
Division name
Dept. of Orthopaedic Surgery
Zip code
113-0033
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo 113-0033, Japan
TEL
03-3815-5411
Homepage URL
oscis-core@umin.ac.jp
Sponsor or person
Institute
The Univerisity of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Committee for Study of Ossification of Spinal Ligaments, Ministry of Health, Labour, and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Univerisity of Tokyo
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo 113-0033, Japan
Tel
03-5841-0818
ethics@m.u-tokyo.ac.jp
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
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2785876
Publication of results
Partially published
Result
URL related to results and publications
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2785876
Number of participants that the trial has enrolled
72
Results
The results of this trial suggest that among patients with cervical SCI, early surgical treatment produced similar motor regain at 1 year after injury as delayed surgical treatment but showed accelerated recovery within the first 6 months. These exploratory results suggest that early surgical treatment leads to faster neurological recovery.
Results date posted
| 2023 | Year | 06 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
JAMA Netw Open. 2021;4(11):e2133604. doi:10.1001/jamanetworkopen.2021.33604
Participant flow
JAMA Netw Open. 2021;4(11):e2133604. doi:10.1001/jamanetworkopen.2021.33604
Adverse events
JAMA Netw Open. 2021;4(11):e2133604. doi:10.1001/jamanetworkopen.2021.33604
Outcome measures
JAMA Netw Open. 2021;4(11):e2133604. doi:10.1001/jamanetworkopen.2021.33604
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2023 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008009
