Clinical outcomes with selectively constrained SECURE-C cervical disc arthroplasty: two-year results from a prospective, randomized, controlled, multicenter investigational device exemption study

Spine
Alexander VaccaroKelly J Baker

Abstract

Prospective, multicenter, randomized, and controlled Investigational Device Exemption clinical trial. To compare the clinical safety and effectiveness of the selectively constrained SECURE-C (Globus Medical, Audubon, PA) Cervical Artificial Disc to anterior cervical discectomy and fusion (ACDF). Cervical total disc replacement has been developed as an alternative to ACDF by allowing segmental motion. Current cervical total disc replacement designs incorporate constrained and unconstrained metal-on-metal or metal-on-polymer articulating designs with various means of fixation. A total of 380 patients from 18 investigational sites were prospectively enrolled in the study. Patients were randomized, treated surgically, and evaluated postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months. Clinical outcomes include overall success, visual analogue scale pain (right arm, left arm, and neck), neck disability index, neurological status, Short Form 36 (SF-36) Health Status Survey questionnaires, range of motion, and adverse events. Bayesian statistical methods were used to analyze the outcomes. Overall success results demonstrated statistical superiority of the randomized SECURE-C group compared with the randomized ACDF ...Continue Reading

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Citations

Feb 3, 2016·Clinical Orthopaedics and Related Research·Zhao-Ming ZhongJian-Ting Chen
May 20, 2015·The Spine Journal : Official Journal of the North American Spine Society·Michael F ShriverThomas E Mroz
Jun 23, 2015·Asian Spine Journal·Branko SkovrljSamuel Kang-Wook Cho
Mar 5, 2015·HSS Journal : the Musculoskeletal Journal of Hospital for Special Surgery·John D KoernerTodd J Albert
Jul 29, 2016·Neurosurgical Review·Michael D StaudtNeil Duggal
Oct 16, 2016·The Spine Journal : Official Journal of the North American Spine Society·S Raymond Golish, Michael L Reed
Feb 2, 2017·Neurosurgical Focus·Domagoj CoricJeffrey Wang
Feb 2, 2017·Neurosurgical Focus·Hsuan-Kan ChangHenrich Cheng
Feb 2, 2017·Neurosurgical Focus·Mazda K TurelVincent C Traynelis
Jan 13, 2018·Neurosurgery·Pierce D NunleyMarcus B Stone
Jan 10, 2019·International Orthopaedics·Andrei F JoaquimK Daniel Riew
Jul 19, 2018·Spine·Christoph MehrenKarin Wuertz-Kozak
May 11, 2019·Journal of Neurosurgery. Spine·Matthew F GornetAnne G Copay
Oct 5, 2018·The Journal of the American Academy of Orthopaedic Surgeons·Theodore D KoreckijDaniel K Park
Mar 30, 2017·Current Reviews in Musculoskeletal Medicine·Alfred Pisano, Melvin Helgeson
Oct 24, 2019·European Spine Journal : Official Publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society·Caroline M W GoedmakersCarmen L A Vleggeert-Lankamp
Jan 4, 2020·European Spine Journal : Official Publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society·Richard D GuyerJack E Zigler
May 12, 2017·Current Reviews in Musculoskeletal Medicine·Dante LevenSheeraz Qureshi
Aug 1, 2019·European Spine Journal : Official Publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society·T DufourJ P Steib
Dec 7, 2018·International Orthopaedics·Melvin C MakhniKiehyun Daniel Riew
Feb 19, 2019·Global Spine Journal·Nikhil R NayakNeil R Malhotra
Apr 22, 2020·Global Spine Journal·S Raymond GolishJason A Inzana
Jun 13, 2020·Global Spine Journal·Jonathan M Parish, Domagoj Coric

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