Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT01367405
Status:
TERMINATED
Last Update Posted:
2016-10-13
First Post:
2011-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing Surgical Decompression Versus Conservative Treatment in Incomplete Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020210', 'term': 'Central Cord Syndrome'}], 'ancestors': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019299', 'term': 'Decompression, Surgical'}, {'id': 'D000072700', 'term': 'Conservative Treatment'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'only 1 inclusion in 1.5 years due to strict exclusion criteria', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-12', 'studyFirstSubmitDate': '2011-06-06', 'studyFirstSubmitQcDate': '2011-06-06', 'lastUpdatePostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dutch translation of mJOA', 'timeFrame': 'two years post-injury', 'description': 'functional outcome at two years measured by Dutch translation of mJOA'}], 'secondaryOutcomes': [{'measure': 'DASH', 'timeFrame': 'two years post-injury', 'description': 'arm/hand function assessed by the disability of the arm, shoulder and hand questionnaire (DASH)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Surgical decompression', 'conservative treatment', 'incomplete spinal cord lesion', 'recovery'], 'conditions': ['Central Spinal Cord Syndrome']}, 'referencesModule': {'references': [{'pmid': '23369169', 'type': 'DERIVED', 'citation': 'Bartels RH, Hosman AJ, van de Meent H, Hofmeijer J, Vos PE, Slooff WB, Oner FC, Coppes MH, Peul WC, Verbeek AL. Design of COSMIC: a randomized, multi-centre controlled trial comparing conservative or early surgical management of incomplete cervical cord syndrome without spinal instability. BMC Musculoskelet Disord. 2013 Jan 31;14:52. doi: 10.1186/1471-2474-14-52.'}]}, 'descriptionModule': {'briefSummary': 'Traumatic Central Cord Syndrome (TCCS) was until recent recognized as a separate clinical entity. The most characteristic feature is the disproportionate more motor impairment of the arms and especially the hands than the legs, bladder dysfunction and sensory.\n\nRecently, it has been shown that the distinction of TCCS with an incomplete cervical spinal cord lesion (ICSCL) is artificial. It is the most frequent incomplete traumatic spinal cord lesion. It accounts for up to 70 % of all incomplete cervical spinal cord lesions. The exact incidence is not known.\n\nUncertainty about the treatment exists. A good recovery has been described after conservative treatment. Conservative treatment was usually considered when a fracture or dislocation of the spine were absent. It is often seen in hyperextension trauma in the elderly with degenerative spondylotic stenotic cervical spine. However, some reports suggest a better outcome after surgical decompression. Randomized trials have not been performed. To avoid discussion about possible confounding or effect modification related to the mechanism of trauma, this study will focus on ICSCL in patients without fracture or instability of the cervical spine on radiological examination. Also the problem of crossover from the conservative group to the surgical one due to the nature of spinal instability will be reduced.\n\nGoal of the study: To compare the efficacy of early decompressive surgery to improve functional outcome in patients with ICSCL without a fracture or instability of the cervical spine compared to those receiving conservative treatment.\n\nDefinition of ICSCL in this study: ICSCL is an incomplete spinal cord lesion due to a cervical spine trauma. At CT scanning with reconstruction and at MRI signs are not seen that could indicate a fracture of the cervical spine or instability. An overt sequestrated herniated disc should not be present since this will always necessitate immediate surgery. Involvement of the cervical spinal cord should be established at physical examination (symptomatic arm or hand dysfunction is obligatory).', 'detailedDescription': 'See Above. Further information in this registration ( Randomized controlled trial (RCT), sample size etc)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- all patients with a history of a traumatic event to the cervical spine fulfilling the criteria of incomplete cervical spinal cord lesion. -\n\nExclusion Criteria:\n\n* cognitive impairments\n* a preexistent neurologic deficit of arms and/or legs\n* psychiatric illness\n* significant comorbidity interfering with the indication to perform surgery or not\n* use of anticoagulating drugs\n* addiction to drugs or alcohol (more than five units daily)\n* not speaking Dutch language fluently\n* not willing to participate\n* participating in another trial'}, 'identificationModule': {'nctId': 'NCT01367405', 'acronym': 'COSMIC', 'briefTitle': 'Comparing Surgical Decompression Versus Conservative Treatment in Incomplete Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'COSMIC: Conservative or Early Surgical Management of Incomplete Cervical Cord Syndrome Without Spinal Instability. Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NL36977.091.11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'surgical decompression', 'description': 'surgical decompression within 24 hours post-injury', 'interventionNames': ['Procedure: Surgical decompression']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conservative treatment', 'description': 'Normal conservative treatment without surgical intervention', 'interventionNames': ['Procedure: Conservative treatment']}], 'interventions': [{'name': 'Surgical decompression', 'type': 'PROCEDURE', 'description': 'Surgical decompression within 24 hour postinjury', 'armGroupLabels': ['surgical decompression']}, {'name': 'Conservative treatment', 'type': 'PROCEDURE', 'description': 'Usual conservative treatment without surgery', 'armGroupLabels': ['Conservative treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500 HB', 'city': 'Nijmegen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Radboud University Nijmegen Medical Center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Ronald Bartels, M.D.,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}