Stand-Alone Cage Verus Anterior Plating for Anterior Cervical Discectomy and Fusion.
NCT ID: NCT03312192
Last Updated: 2021-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2017-07-17
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Plate and Cage
ACDF with interbody cage and anterior plating.
Interbody Cage and Anterior Plating
Anterior cervical discectomy and fusion with interbody cage placement and anterior plating
Stand Alone Cage
ACDF with stand alone interbody cage without anterior plating
Interbody Cage
Anterior cervical discectomy and fusion with interbody cage placement
Interventions
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Interbody Cage
Anterior cervical discectomy and fusion with interbody cage placement
Interbody Cage and Anterior Plating
Anterior cervical discectomy and fusion with interbody cage placement and anterior plating
Eligibility Criteria
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Inclusion Criteria
(a) Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, and foraminal stenosis
* Patients able to provide informed consent
Exclusion Criteria
ALL
No
Sponsors
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Rush University Medical Center
OTHER
Responsible Party
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Carla Edwards
Clinical Research Manger
Principal Investigators
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Kern Singh, MD
Role: PRINCIPAL_INVESTIGATOR
Rush University Medical Center
Locations
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Rush University Medical Center
Chicago, Illinois, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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14021901
Identifier Type: -
Identifier Source: org_study_id
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