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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000006780 | Registry Identifier | UMIN-CTR |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early surgery | Experimental |
| |
| Delayed surgery | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early surgery | Procedure | Surgery within 24 hours after admission |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related quality of life | SF-36 EQ-5D | one year |
| Neuropathic pain | Neuropathic Pain Symptom Inventory | one year |
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Inclusion Criteria:
Patients with acute traumatic cervical spinal cord injury (at C5 or below) admitted within 48 hours after injury
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hirotaka Chikuda, MD, PhD | Tokyo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Tokyo | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34751757 | Derived | 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. | |
| 23924165 |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D017887 | Ossification of Posterior Longitudinal Ligament |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| Delayed surgery |
| Procedure |
Surgery more than 2 weeks after injury |
|
| Walking status | Walking Index for Spinal Cord Injury (WISCI) II | one year |
| 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. |
| D014947 | Wounds and Injuries |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009999 | Ossification, Heterotopic |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |