Spinal Cord InjuryOSCISNCT01485458
Optimal Treatment for Spinal Cord Injury Associated With Cervical Canal Stenosis (OSCIS) Study
A study testing Early surgery and Delayed surgery in people with Spinal Cord Injury, run by Tokyo University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Early surgery and Delayed surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2011to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial of Early Versus Delayed Surgery for Acute Traumatic Cervical Spinal Cord Injury Without Bone Injury in Patients With Cervical Canal Stenosis
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
- Being tested
- Early surgery, Delayed surgery
- Keywords
- Incomplete spinal cord injury, Cervical canal stenosis, Ossification of the posterior longitudinal ligament, Surgery, Decompression
- Medical subject headings
- Spinal Cord Injuries, Ossification of Posterior Longitudinal Ligament
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early surgeryProcedure or surgery
Surgery within 24 hours after admission
Delayed surgeryProcedure or surgery
Surgery more than 2 weeks after injury
| Study group | Role | What they receive |
|---|---|---|
| Early surgery | Experimental | Not described Receives: Procedure: Early surgery |
| Delayed surgery | Active comparator | Not described Receives: Procedure: Delayed surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASIA motor score
change from baseline to one year in the American Spinal Injury Association (ASIA) motor score
Measured: baseline and one year
the ability to walk without assistance
proportion of patients who regained the ability to walk without assistance
Measured: one year
Spinal Cord Independence Measure (SCIM)
the total score of the Spinal Cord Independence Measure (SCIM) version 3
Measured: one year
Secondary outcomes (3)
Health-related quality of life
SF-36 EQ-5D
Measured: one year
Neuropathic pain
Neuropathic Pain Symptom Inventory
Measured: one year
Walking status
Walking Index for Spinal Cord Injury (WISCI) II
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2019
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokyo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hirotaka Chikuda, Tokyo University
- Investigators
- Hirotaka Chikuda, MD, PhD, Principal investigator, Tokyo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485458
- Sponsor's protocol ID
- OSCIS
- Other IDs
- UMIN000006780
- Acronym
- OSCIS
- Status last verified
- Mar 2021
- First submitted
- 30 Nov 2011
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 34751757Chikuda 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Early Versus Delayed Surgery for Acute Traumatic Cervical Spinal Cord Injury Without Bone Injury in Patients With Cervical Canal Stenosis
- ClinicalTrials.gov ID
- NCT01485458
- Acronym / sponsor ID
- OSCIS / OSCIS
- Conditions
- Spinal Cord Injury
- Keywords
- Incomplete spinal cord injury, Cervical canal stenosis, Ossification of the posterior longitudinal ligament, Surgery, Decompression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Tokyo UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 5 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early surgery | Experimental | Procedure: Early surgery |
| Delayed surgery | Active comparator | Procedure: Delayed surgery |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with acute traumatic cervical spinal cord injury (at C5 or below) admitted within 48 hours after injury
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early surgerySurgery within 24 hours after admission | Procedure or surgery | Early surgery |
| Delayed surgerySurgery more than 2 weeks after injury | Procedure or surgery | Delayed surgery |
Primary outcome
ASIA motor score
Time frame: baseline and one year
change from baseline to one year in the American Spinal Injury Association (ASIA) motor score
the ability to walk without assistance
Time frame: one year
proportion of patients who regained the ability to walk without assistance
Spinal Cord Independence Measure (SCIM)
Time frame: one year
the total score of the Spinal Cord Independence Measure (SCIM) version 3
3 secondary outcomes
Health-related quality of life
Time frame: one year
Neuropathic pain
Time frame: one year
Walking status
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Derived from this study: PubMed 34751757OSCIS 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.
- Derived from this study: PubMed 23924165Chikuda 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hirotaka Chikuda, MD, PhD principal investigator
Tokyo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early surgery and Delayed surgery in people with Spinal Cord Injury, run by Tokyo University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASIA motor score (time frame: baseline and one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01485458, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.