Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT01485458
Status:
COMPLETED
Last Update Posted:
2021-04-01
First Post:
2011-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimal Treatment for Spinal Cord Injury Associated With Cervical Canal Stenosis (OSCIS) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D017887', 'term': 'Ossification of Posterior Longitudinal Ligament'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009999', 'term': 'Ossification, Heterotopic'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-29', 'studyFirstSubmitDate': '2011-11-30', 'studyFirstSubmitQcDate': '2011-12-02', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ASIA motor score', 'timeFrame': 'baseline and one year', 'description': 'change from baseline to one year in the American Spinal Injury Association (ASIA) motor score'}, {'measure': 'the ability to walk without assistance', 'timeFrame': 'one year', 'description': 'proportion of patients who regained the ability to walk without assistance'}, {'measure': 'Spinal Cord Independence Measure (SCIM)', 'timeFrame': 'one year', 'description': 'the total score of the Spinal Cord Independence Measure (SCIM) version 3'}], 'secondaryOutcomes': [{'measure': 'Health-related quality of life', 'timeFrame': 'one year', 'description': 'SF-36 EQ-5D'}, {'measure': 'Neuropathic pain', 'timeFrame': 'one year', 'description': 'Neuropathic Pain Symptom Inventory'}, {'measure': 'Walking status', 'timeFrame': 'one year', 'description': 'Walking Index for Spinal Cord Injury (WISCI) II'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Incomplete spinal cord injury', 'Cervical canal stenosis', 'Ossification of the posterior longitudinal ligament', 'Surgery', 'Decompression'], 'conditions': ['Spinal Cord Injury']}, 'referencesModule': {'references': [{'pmid': '34751757', 'type': 'DERIVED', 'citation': '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': '23924165', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with acute traumatic cervical spinal cord injury (at C5 or below) admitted within 48 hours after injury\n\n 1. No bone injury (no fracture or instability)\n 2. American Spinal Injury Association (ASIA) Impairment Grade C\n 3. Cervical canal stenosis due to preexisting conditions such as spondylosis and ossification of the posterior longitudinal ligament (OPLL)\n\nExclusion Criteria:\n\n1. Unstable medical status\n2. Difficult to undergo surgery within 24 hours after admission\n3. Impaired consciousness or mental disorder that precludes neurological examination\n4. Difficult to obtain informed consent in Japanese'}, 'identificationModule': {'nctId': 'NCT01485458', 'acronym': 'OSCIS', 'briefTitle': 'Optimal Treatment for Spinal Cord Injury Associated With Cervical Canal Stenosis (OSCIS) Study', 'organization': {'class': 'OTHER', 'fullName': 'Tokyo University'}, 'officialTitle': 'Randomized Trial of Early Versus Delayed Surgery for Acute Traumatic Cervical Spinal Cord Injury Without Bone Injury in Patients With Cervical Canal Stenosis', 'orgStudyIdInfo': {'id': 'OSCIS'}, 'secondaryIdInfos': [{'id': 'UMIN000006780', 'type': 'REGISTRY', 'domain': 'UMIN-CTR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early surgery', 'interventionNames': ['Procedure: Early surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Delayed surgery', 'interventionNames': ['Procedure: Delayed surgery']}], 'interventions': [{'name': 'Early surgery', 'type': 'PROCEDURE', 'description': 'Surgery within 24 hours after admission', 'armGroupLabels': ['Early surgery']}, {'name': 'Delayed surgery', 'type': 'PROCEDURE', 'description': 'Surgery more than 2 weeks after injury', 'armGroupLabels': ['Delayed surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'The University of Tokyo', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Hirotaka Chikuda, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tokyo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tokyo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Hirotaka Chikuda', 'investigatorAffiliation': 'Tokyo University'}}}}