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Prospective randomized controlled study of the Bryan Cervical Disc: early clinical results from a single investigational site

Invited submission from the Joint Section Meeting on Disorders of the Spine and Peripheral Nerves, March 2005

Domagoj Coric, Frederick Finger and Peggy Boltes

decompression and comparable clinical outcome to ACDF in the short term. Furthermore, there was no evidence of device-related complications such as loosening, subsidence, or failure of the implant. The authors of recent case reports have described spontaneous fusion and loss of motion at the site of Bryan disc arthroplasty within 1 to 2 years of implantation. 2 , 13 In the present study motion was preserved without bridging bone in all arthroplasty-treated patients. Continuing to follow this prospective randomized cohort of patients in the long term will help us establish

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Gwynedd E. Pickett, Lali H. S. Sekhon, William R. Sears and Neil Duggal

with those of ACDF. 1 , 17 We describe complications observed following implantation of the Bryan disc prosthesis in a cohort of 74 patients treated at two tertiary care centers. Clinical Material and Methods All patients presenting with cervical disc herniation or spondylosis producing radiculopathy and/or myelopathy, for whom ACD was recommended, were considered candidates for Bryan disc arthroplasty as an alternative to fusion. Patients with single- and multilevel disease were eligible for treatment. Exclusion criteria included radiographically documented

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Neil R. Crawford, Jeffery D. Arnett, Joshua A. Butters, Lisa A. Ferrara, Nikhil Kulkarni, Vijay K. Goel and Neil Duggal

vitro biomechanical construct tests evaluating cervical arthroplasty . World Spine J 1 : 7 – 13 , 2006 3 DiAngelo DJ , Roberston JT , Metcalf NH , McVay BJ , Davis RC : Biomechanical testing of an artificial cervical joint and an anterior cervical plate . J Spinal Disord Tech 16 : 314 – 323 , 2003 4 Fong SY , DuPlessis SJ , Casha S , Hurlbert RJ : Design limitations of Bryan disc arthroplasty . Spine J 6 : 233 – 241 , 2006 5 Goel VK , Clausen JD : Prediction of load sharing among spinal components of a C5-C6 motion

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Bruno C. R. Lazaro, Kemal Yucesoy, Kasim Z. Yuksel, Izabela Kowalczyk, Doron Rabin, Marie Fink and Neil Duggal

15 Fehlings MJ , Gray R : Editorial. Importance of sagittal balance in determining the outcome of anterior versus posterior surgery for cervical spondylotic myelopathy . J Neurosurg Spine 11 : 518 – 520 , 2009 16 Ferch RD , Shad A , Cadoux-Hudson TA , Teddy PJ : Anterior correction of cervical kyphotic deformity: effects on myelopathy, neck pain, and sagittal alignment . J Neurosurg Spine 100 : 1 Suppl 13 – 19 , 2004 17 Fong SY , DuPlessis SJ , Casha S , Hurlbert RJ : Design limitations of Bryan disc arthroplasty . Spine J

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Ricardo Vieira Botelho, Osmar José dos Santos Moraes, Gustavo Alberto Fernandes, Yuri dos Santos Buscariolli and Wanderley Marques Bernardo

: 2354 – 2364 , 2008 20 Riina J , Patel A , Dietz JW , Hoskins JS , Trammell TR , Schwartz DD : Comparison of single-level cervical fusion and a metal-on-metal cervical disc replacement device . Am J Orthop 37 : E71 – 77 , 2008 21 Sasso RC , Best NM : Cervical kinematics after fusion and Bryan disc arthroplasty . J Spinal Disord Tech 21 : 19 – 22 , 2008 22 Sasso RC , Best NM , Metcalf NH , Anderson PA : Motion analysis of Bryan cervical disc arthroplasty versus anterior discectomy and fusion: results from a prospective

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Krista Keachie, Kiarash Shahlaie and J. Paul Muizelaar

clinical trial . Neurosurg Focus 17 : 3 E6 , 2004 45 Prabhakar MM , Thakker T : Anterior decompression for cervicothoracic pathology: A study of 14 patients . J Spinal Cord Med 29 : 163 – 166 , 2006 46 Riew KD , Buchowski JM , Sasso R , Zdeblick T , Metcalf NH , Anderson PA : Cervical disc arthroplasty compared with arthrodesis for the treatment of myelopathy . J Bone Joint Surg Am 90 : 2354 – 2364 , 2008 47 Sasso RC , Best NM : Cervical kinematics after fusion and bryan disc arthroplasty . J Spinal Disord Tech 21 : 19

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J. Kenneth Burkus, Regis W. Haid Jr., Vincent C. Traynelis and Praveen V. Mummaneni

: 519 – 528 , 1999 16 Ipsen BJ , Kim DH , Jenis LG , Tromanhauser SG , Banco RJ : Effect of plate position on clinical outcome after anterior cervical spine surgery . Spine J 7 : 637 – 642 , 2007 17 Kim SW , Limson MA , Kim SB , Arbatin JJ , Chang KY , Park MS , : Comparison of radiographic changes after ACDF versus Bryan disc arthroplasty in single and bi-level cases . Eur Spine J 18 : 218 – 231 , 2009 18 Kulkarni V , Rajshekhar V , Raghuram L : Accelerated spondylotic changes adjacent to the fused segment

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Tsung-Hsi Tu, Jau-Ching Wu, Wen-Cheng Huang, Wan-Yuo Guo, Ching-Lan Wu, Yang-Hsin Shih and Henrich Cheng

. Clin Orthop Relat Res 196 : 217 – 225 , 1985 29 Robertson JT , Papadopoulos SM , Traynelis VC : Assessment of adjacent-segment disease in patients treated with cervical fusion or arthroplasty: a prospective 2-year study . J Neurosurg Spine 3 : 417 – 423 , 2005 30 Sasso RC , Best NM : Cervical kinematics after fusion and bryan disc arthroplasty . J Spinal Disord Tech 21 : 19 – 22 , 2008 31 Sasso RC , Smucker JD , Hacker RJ , Heller JG : Artificial disc versus fusion: a prospective, randomized study with 2-year follow-up on

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Domagoj Coric, Pierce D. Nunley, Richard D. Guyer, David Musante, Cameron N. Carmody, Charles R. Gordon, Carl Lauryssen, Donna D. Ohnmeiss and Margaret O. Boltes

, Braunstein EM , Bailey RW : Radiographic changes following anterior cervical fusion . Spine (Phila Pa 1976) 5 : 399 – 401 , 1980 29 Ishihara H , Kanamori M , Kawaguchi Y , Nakamura H , Kimura T : Adjacent segment disease after anterior cervical interbody fusion . Spine J 4 : 624 – 628 , 2004 30 Kim SW , Limson MA , Kim SB , Arbatin JJ , Chang KY , Park MS , : Comparison of radiographic changes after ACDF versus Bryan disc arthroplasty in single and bi-level cases . Eur Spine J 18 : 218 – 231 , 2009 31 Kulkarni V

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Izabela Kowalczyk, Bruno C. R. Lazaro, Marie Fink, Doron Rabin and Neil Duggal

preoperative DA (at the index level) of −0.7° (47 patients). Fong et al. 13 studied 10 patients undergoing Bryan disc arthroplasty and found that 40% had angles between 1° and 2° and that 30% had angles that were straight (parallel with 0°). Johnson et al. 19 studied 13 patients with a mean preoperative angle of 1° and noted that the symptomatic segment was kyphotic because of a loss of ADH. Our results confirm that DDD results in focal loss of lordosis. Harrison et al. 16 studied 252 individuals and found that the average lordosis between cervical vertebrae was between 6