Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2026-01-23 @ 1:54 PM
Study NCT ID:
NCT03312192
Status:
WITHDRAWN
Last Update Posted:
2021-09-16
First Post:
2017-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stand-Alone Cage Verus Anterior Plating for Anterior Cervical Discectomy and Fusion.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-09', 'size': 3805160, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-12-10T09:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1\\. Stand-alone ACDF, which means the placement of an interbody device (cage) without anterior fixation or plating; 2. ACDF with and interbody cage and anterior plating for fixation.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'poor recruitment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-08', 'studyFirstSubmitDate': '2017-08-08', 'studyFirstSubmitQcDate': '2017-10-11', 'lastUpdatePostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '1 year', 'description': '(a) Intra-operative - Information will be obtained from the operative note. (i) Blood loss, length of surgery, procedural details, complications (b) Post-operative - Information will be obtained from the clinic notes'}, {'measure': 'Narcotics Consumption', 'timeFrame': '3 days', 'description': 'The total amount of narcotic use for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents. This information will be measured during the hospitalization.'}], 'primaryOutcomes': [{'measure': 'Clinical Improvement - Change in Baseline Visual analogue Score (VAS) for Pain', 'timeFrame': '6 months', 'description': 'Patients will be asked to complete the VAS to measure their pain prior to surgery and at their preoperative office visit(s) or just prior to surgery in the preoperative waiting area. Scores at the 6 month follow up office visit will be compared to baseline'}], 'secondaryOutcomes': [{'measure': 'Dysphagia', 'timeFrame': '6 months', 'description': '6 month postoperative followup SWAL-QOL score will be compared to baseline'}, {'measure': 'Fusion Rates', 'timeFrame': '6 months', 'description': 'Postoperative radiographic studies will be performed at 6 month follow up visit to assess for arthrodesis (fusion) and pseudarthrosis (non-fusion).'}, {'measure': 'Clinical Improvement - Change in baseline 12-item Short Form (SF-12) Health Survey at 6 months', 'timeFrame': '6 months', 'description': 'SF-12 survey scores at 6 month follow up will be compared to baseline'}, {'measure': 'Clinical Improvement - Change in baseline Oswestry Disability Index (ODI) at 6 months', 'timeFrame': '6 months', 'description': 'ODI survey scores at 6 month follow up will be compared to baseline'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Anterior Cervical Discectomy and Fusion', 'Stand-Alone Cage', 'Anterior Plating'], 'conditions': ['Degenerative Disc Disease', 'Cervical Spine Degeneration']}, 'referencesModule': {'references': [{'pmid': '23897053', 'type': 'BACKGROUND', 'citation': 'Ji GY, Oh CH, Shin DA, Ha Y, Kim KN, Yoon DH, Yudoyono F. Stand-alone Cervical Cages Versus Anterior Cervical Plates in 2-Level Cervical Anterior Interbody Fusion Patients: Analysis of Adjacent Segment Degeneration. J Spinal Disord Tech. 2015 Aug;28(7):E433-8. doi: 10.1097/BSD.0b013e3182a355ad.'}, {'pmid': '23890389', 'type': 'BACKGROUND', 'citation': 'Choi KC, Ryu KS, Lee SH, Kim YH, Lee SJ, Park CK. Biomechanical comparison of anterior lumbar interbody fusion: stand-alone interbody cage versus interbody cage with pedicle screw fixation -- a finite element analysis. BMC Musculoskelet Disord. 2013 Jul 26;14:220. doi: 10.1186/1471-2474-14-220.'}, {'pmid': '22367466', 'type': 'BACKGROUND', 'citation': 'Oh JK, Kim TY, Lee HS, You NK, Choi GH, Yi S, Ha Y, Kim KN, Yoon DH, Shin HC. Stand-alone cervical cages versus anterior cervical plate in 2-level cervical anterior interbody fusion patients: clinical outcomes and radiologic changes. J Spinal Disord Tech. 2013 Dec;26(8):415-20. doi: 10.1097/BSD.0b013e31824c7d22.'}, {'pmid': '22872219', 'type': 'BACKGROUND', 'citation': 'Lee MJ, Dettori JR, Standaert CJ, Ely CG, Chapman JR. Indication for spinal fusion and the risk of adjacent segment pathology: does reason for fusion affect risk? A systematic review. Spine (Phila Pa 1976). 2012 Oct 15;37(22 Suppl):S40-51. doi: 10.1097/BRS.0b013e31826ca9b1.'}, {'pmid': '15541666', 'type': 'BACKGROUND', 'citation': 'Hilibrand AS, Robbins M. Adjacent segment degeneration and adjacent segment disease: the consequences of spinal fusion? Spine J. 2004 Nov-Dec;4(6 Suppl):190S-194S. doi: 10.1016/j.spinee.2004.07.007.'}, {'pmid': '23281466', 'type': 'BACKGROUND', 'citation': 'Cho SK, Riew KD. Adjacent segment disease following cervical spine surgery. J Am Acad Orthop Surg. 2013 Jan;21(1):3-11. doi: 10.5435/JAAOS-21-01-3.'}, {'pmid': '22885835', 'type': 'BACKGROUND', 'citation': 'Kraemer P, Fehlings MG, Hashimoto R, Lee MJ, Anderson PA, Chapman JR, Raich A, Norvell DC. A systematic review of definitions and classification systems of adjacent segment pathology. Spine (Phila Pa 1976). 2012 Oct 15;37(22 Suppl):S31-9. doi: 10.1097/BRS.0b013e31826d7dd6.'}, {'pmid': '17532499', 'type': 'BACKGROUND', 'citation': 'Mobbs RJ, Rao P, Chandran NK. Anterior cervical discectomy and fusion: analysis of surgical outcome with and without plating. J Clin Neurosci. 2007 Jul;14(7):639-42. doi: 10.1016/j.jocn.2006.04.003.'}, {'pmid': '9657188', 'type': 'BACKGROUND', 'citation': 'Savolainen S, Rinne J, Hernesniemi J. A prospective randomized study of anterior single-level cervical disc operations with long-term follow-up: surgical fusion is unnecessary. Neurosurgery. 1998 Jul;43(1):51-5. doi: 10.1097/00006123-199807000-00032.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the clinical results between two different techniques for ACDF: 1. Stand-alone ACDF, which means the placement of an interbody device (cage) without anterior fixation or plating; 2. ACDF with and interbody cage and anterior plating for fixation. Both of these procedures are commonly performed at Rush with unclear advantage of one procedure over the other. Both have been associated with good to excellent clinical outcomes. The devices used in this study are approved by the Food and Drug Administration (FDA).', 'detailedDescription': 'Anterior cervical discectomy and fusion (ACDF) is one the most common procedures performed by spine surgeons. Although ACDF with autologous bone graft and anterior plating is commonly performed, this procedure may be associated with postoperative dysphagia, significant costs and adjacent segment pathology. To address these concerns, a number of surgeons have opted to utilize an interbody cage in a stand-alone fashion with good to excellent results. However, the published data is limited and currently there in no consensus among spine surgeons regarding the best technique to achieve fusion and improve clinical outcomes in patients with degenerative disc disease in the cervical spine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing a primary 1- to 2-level ACDF\n\n (a) Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, and foraminal stenosis\n* Patients able to provide informed consent\n\nExclusion Criteria:\n\n* Cervical spine trauma'}, 'identificationModule': {'nctId': 'NCT03312192', 'briefTitle': 'Stand-Alone Cage Verus Anterior Plating for Anterior Cervical Discectomy and Fusion.', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'Stand-Alone Cage Versus Anterior Plating for 1-2 Level Anterior Cervical Discectomy and Fusion. A Clinical and Radiographic Analysis', 'orgStudyIdInfo': {'id': '14021901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Plate and Cage', 'description': 'ACDF with interbody cage and anterior plating.', 'interventionNames': ['Device: Interbody Cage and Anterior Plating']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stand Alone Cage', 'description': 'ACDF with stand alone interbody cage without anterior plating', 'interventionNames': ['Device: Interbody Cage']}], 'interventions': [{'name': 'Interbody Cage', 'type': 'DEVICE', 'description': 'Anterior cervical discectomy and fusion with interbody cage placement', 'armGroupLabels': ['Stand Alone Cage']}, {'name': 'Interbody Cage and Anterior Plating', 'type': 'DEVICE', 'description': 'Anterior cervical discectomy and fusion with interbody cage placement and anterior plating', 'armGroupLabels': ['Plate and Cage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Kern Singh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rush University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Research Manger', 'investigatorFullName': 'Carla Edwards', 'investigatorAffiliation': 'Rush University Medical Center'}}}}