Cervical total disc replacement with the mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: A prospective, randomized, controlled multicenter clinical trial: Clinical article

Journal of Neurosurgery: Spine

Volumn 19, Issue 5, 2013, Pages 532-545

  Davis, Reginald J ^a   Kim, Kee D ^b   Hisey, Michael S ^c   Hoffman, Gregory A ^d   Bae, Hyun W ^e   Gaede, Steven E ^f   Rashbaum, Ralph F ^c   Nunley, Pierce Dalton ^g   Peterson, Daniel L ^h   Stokes, John K ⁱ  

^a Greater Baltimore Neurosurgical   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c TEXAS BACK INSTITUTE   (United States)

^d Orthopaedics Northeast PC   (United States)

^e CEDARS SINAI MEDICAL CENTER   (United States)

^f Oklahoma Spine and Brain Institute   (United States)

^g Spine Institute of Louisiana   (United States)

^h SpineAustin   (United States)

ⁱ Seton Spine and Scoliosis Center   (United States)

Author keywords

Anterior cervical discectomy and fusion; Cervical arthroplasty; Cervical artificial disc; Degenerative disc disease; Mobi c; Multilevel

Indexed keywords

ADULT; ALLOGRAFT; ANTERIOR DISCECTOMY AND FUSION; ARM PAIN; ARTICLE; CERVICAL SPINE; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; DISK PROSTHESIS; FEMALE; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; HUMAN; INTERVERTEBRAL DISK DEGENERATION; INTERVERTEBRAL DISKECTOMY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NECK PAIN; POSTOPERATIVE PERIOD; RANDOMIZED CONTROLLED TRIAL; RANGE OF MOTION; REOPERATION; SAFETY; SPINE FUSION; TOTAL DISC REPLACEMENT; VISUAL ANALOG SCALE;

ADULT; ARTHROPLASTY; CERVICAL VERTEBRAE; DISABILITY EVALUATION; DISKECTOMY; FEMALE; HUMANS; INTERVERTEBRAL DISC DEGENERATION; MALE; MIDDLE AGED; ORTHOPEDIC PROCEDURES; PAIN MEASUREMENT; PROSPECTIVE STUDIES; PROSTHESES AND IMPLANTS; RANGE OF MOTION, ARTICULAR; SPINAL FUSION; TOTAL DISC REPLACEMENT; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84887101050     PISSN: 15475654     EISSN: 15475646     Source Type: Journal    
DOI: 10.3171/2013.6.SPINE12527     Document Type: Article

References (49)

1. Anderson PA, Rouleau JP: Intervertebral disc arthroplasty. Spine (Phila Pa 1976) 29:2779-2786, 2004. (Pubitemid 40353264)
2. Brodke DS, Zdeblick TA: Modified Smith-Robinson procedure for anterior cervical discectomy and fusion. Spine (Phila Pa 1976) 17 (10 Suppl):S427-S430, 1992.
3. Brown JA, Havel P, Ebraheim N, Greenblatt SH, Jackson WT: Cervical stabilization by plate and bone fusion. Spine (Phila Pa 1976) 13:236-240, 1988.
4. Bui TL, Spector L, Odum S, Darden BV, Segabarth B, Patti J, et al: Adjacent segment degeneration following ProDisc-C Total Disc Replacement (TDR) and Anterior Cervical Discectomy and Fusion (ACDF): Does surgeon bias effect radiographic interpretation? Presented at the annual meeting of the Cervical Spine Research Society, Chicago, 2012 (Abstract) (http://www.csrs.org/web/ searchAbstr/2012-Paper33.pdf) [Accessed July 8, 2013].
5. Carreon LY, Glassman SD, Campbell MJ, Anderson PA: Neck Disability Index, short form-36 physical component summary, and pain scales for neck and arm pain: The minimum clinically important difference and substantial clinical benefit after cervical spine fusion. Spine J 10:469-474, 2010.
6. Chang UK, Kim DH, Lee MC, Willenberg R, Kim SH, Lim J: Range of motion change after cervical arthroplasty with ProDisc-C and prestige artificial discs compared with anterior cervical discectomy and fusion. J Neurosurg Spine 7:40-46, 2007. (Pubitemid 47067738)
7. Coric D, Nunley PD, Guyer RD, Musante D, Carmody CN, Gordon CR, et al: Prospective, randomized, multicenter study of cervical arthroplasty: 269 patients from the Kineflex|C artificial disc investigational device exemption study with a minimum 2-year follow-up. Clinical article. J Neurosurg Spine 15:348-358, 2011.
8. Croft P: An introduction to the Atlas of Standard Radiographs of Arthritis. Rheumatology (Oxford) 44 (Suppl 4):42, 2005.
9. Cummins BH, Robertson JT, Gill SS: Surgical experience with an implanted artificial cervical joint. J Neurosurg 88:943- 948, 1998. (Pubitemid 28261837)
10. Cunningham BW, Hu N, Zorn CM, McAfee PC: Biomechanical comparison of single- And two-level cervical arthroplasty versus arthrodesis: Effect on adjacent-level spinal kinematics. Spine J 10:341-349, 2010.
11. Davis RJ, Araghi A, Bae HW, Hisey MS, Nunley PD: Comparison of complication rates associated with two level cervical arthroplasty versus two level anterior cervical discectomy and fusion. Spine J 12 S139-S140, 2012 (Abstract).
12. Davis RJ, Araghi A, Bae HW, Hisey MS, Nunley PD: Investigational device exemption trial of cervical arthroplasty for treatment of degenerative disc disease at two levels: 24-month results of 330 subjects. Spine J 12:S95-S96, 2012 (Abstract).
13. Davis RJ, Bae HW, Gaede SE, Hisey MS, Kim KD, Nunley PD, et al: Radiographic outcomes including adjacent level degeneration of FDA investigational device trial comparing multi- level use of Mobi-C Cervical Artificial Disc to anterior discectomy and fusion. Presented at the annual meeting of the Cervical Spine Research Society, Scottsdale, AZ, 2011 (Abstract) (http://www.csrs.org/web/searchAbstr/2011-Paper68.pdf) [Accessed July 8, 2013].
14. Dmitriev AE, Cunningham BW, Hu N, Sell G, Vigna F, McAfee PC: Adjacent level intradiscal pressure and segmental kinematics following a cervical total disc arthroplasty: An in vitro human cadaveric model. Spine (Phila Pa 1976) 30:1165- 1172, 2005. (Pubitemid 40695927)
15. Fijn R, Koorevaar RT, Brouwers JR: Prevention of heterotopic ossification after total hip replacement with NSAIDs. Pharm World Sci 25:138-145, 2003. (Pubitemid 36987784)
16. Food and Drug Administration: Summary of Safety and Effectiveness Data: PCM Cervical Disc. (http://www.accessdata.fda.gov/cdrh-docs/pdf10/P100012b.pdf) [Accessed June 19, 2013].
17. Food and Drug Administration: Summary of Safety and Effectiveness Data: SECURE-C Cervical Disc. (http://www.accessdata.fda.gov/cdrh-docs/pdf10/P100003b. pdf) [Accessed June 19, 2013].
18. Fraser JF, Härtl R: Anterior approaches to fusion of the cervical spine: A metaanalysis of fusion rates. J Neurosurg Spine 6:298-303, 2007. (Pubitemid 47066085)
19. Geisler FH, Caspar W, Pitzen T, Johnson TA: Reoperation in patients after anterior cervical plate stabilization in degenerative disease. Spine (Phila Pa 1976) 23:911-920, 1998. (Pubitemid 28188920)
20. Goffin J, Van Calenbergh F, van Loon J, Casey A, Kehr P, Liebig K, et al: Intermediate follow-up after treatment of degenerative disc disease with the Bryan Cervical Disc Prosthesis: singlelevel and bi-level. Spine (Phila Pa 1976) 28:2673-2678, 2003. (Pubitemid 37543472)
21. Harrod CC, Hilibrand AS, Fischer DJ, Skelly AC: Adjacent segement pathology following cervical motion-sparing procedures or devices compared with fusion surgery. Spine (Phila Pa 1976) 37 (22 Suppl):S96-S112, 2012.
22. Heller JG, Sasso RC, Papadopoulos SM, Anderson PA, Fessler RG, Hacker RJ, et al: Comparison of BRYAN cervical disc arthroplasty with anterior cervical decompression and fusion: clinical and radiographic results of a randomized, controlled, clinical trial. Spine (Phila Pa 1976) 34:101-107, 2009.
23. Hilibrand AS, Robbins M: Adjacent segment degeneration and adjacent segment disease: The consequences of spinal fusion? Spine J 4 (6 Suppl):190S-194S, 2004. (Pubitemid 39497304)
24. Hsu WK: The rationale for cervical disc arthroplasty. Tech Orthop 25:84-87, 2010.
25. Jaramillo-de la Torre JJ, Grauer JN, Yue JJ: Update on cervical disc arthroplasty: where are we and where are we going? Curr Rev Musculoskelet Med 1:124-130, 2008.
26. Jawahar A, Cavanaugh DA, Kerr EJ III, Birdsong EM, Nunley PD: Total disc arthroplasty does not affect the incidence of adjacent segment degeneration in cervical spine: results of 93 patients in three prospective randomized clinical trials. Spine J 10:1043-1048, 2010.
27. Kellgren JH, Lawrence JS: Radiological assessment of osteoarthrosis. Ann Rheum Dis 16:494-502, 1957.
28. Kellgren JH, Lawrence JS, Bier F: Genetic factors in generalized osteo-arthrosis. Ann Rheum Dis 22:237-255, 1963.
29. Kjaersgaard-Andersen P, Schmidt SA: Total hip arthroplasty. The role of antiinflammatory medications in the prevention of heterotopic ossification. Clin Orthop Relat Res (263):78-86, 1991.
30. Kulkarni V, Rajshekhar V, Raghuram L: Accelerated spondylotic changes adjacent to the fused segment following central cervical corpectomy: magnetic resonance imaging study evidence. J Neurosurg 100 (1 Suppl Spine):2-6, 2004. (Pubitemid 38010001)
31. Lawrence BD, Hilibrand AS, Brodt ED, Dettori JR, Brodke DS: Predicting the risk of adjacent segment pathology in the cervical spine: A systematic review. Spine (Phila Pa 1976) 37 (22 Suppl):S52-S64, 2012.
32. Lopez-Espina CGAF, Amirouche F, Havalad V: Multilevel cervical fusion and its effect on disc degeneration and osteophyte formation. Spine (Phila Pa 1976) 31:972-978, 2006. (Pubitemid 43785927)
33. McAfee PC, Cunningham BW, Devine J, Williams E, Yu-Yahiro J: Classification of heterotopic ossification (HO) in artificial disk replacement. J Spinal Disord Tech 16:384-389, 2003.
34. McMahon JS, Waddell JP, Morton J: Effect of short-course indomethacin on heterotopic bone formation after uncemented total hip arthroplasty. J Arthroplasty 6:259-264, 1991.
35. Mehren C, Suchomel P, Grochulla F, Barsa P, Sourkova P, Hradil J, et al: Heterotopic ossification in total cervical artificial disc replacement. Spine (Phila Pa 1976) 31:2802-2806, 2006. (Pubitemid 44772781)
36. Mummaneni PV, Burkus JK, Haid RW, Traynelis VC, Zdeblick T: Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: A randomized controlled clinical trial. J Neurosurg Spine 6:198-209, 2007. (Pubitemid 47066071)
37. Murrey D, Janssen M, Delamarter R, Goldstein J, Zigler J, Tay B, et al: Results of the prospective, randomized, controlled multicenter Food and Drug Administration investigational device exemption study of the ProDisc-C total disc replacement versus anterior discectomy and fusion for the treatment of 1-level symptomatic cervical disc disease. Spine J 9:275-286, 2009.
38. Ohnmeiss D, Hisey MS, Bae H, Davis RJ, Hoffman GA, Kim K, et al: Multicenter, prospective, randomized, controlled investigational device exemption study comparing Mobi C Cervical Artificial Disc to anterior fusion in the treatment of symptomatic cervical degenerative disc disease. Spine J 11 Suppl: S16-S17, 2011 (Abstract).
39. Phillips FM, Tzermiadianos MN, Voronov LI, Havey RM, Carandang G, Dooris A, et al: Effect of two-level total disc replacement on cervical spine kinematics. Spine (Phila Pa 1976) 34:E794-E799, 2009.
40. Pimenta L, McAfee PC, Cappuccino A, Cunningham BW, Diaz R, Coutinho E: Superiority of multilevel cervical arthroplasty outcomes versus single-level outcomes: 229 consecutive PCM prostheses. Spine (Phila Pa 1976) 32:1337-1344, 2007. (Pubitemid 46795283)
41. Pracyk JB, Traynelis VC: Treatment of the painful motion segment: cervical arthroplasty. Spine (Phila Pa 1976) 30 (16 Suppl): S23-S32, 2005. (Pubitemid 41208815)
42. Rhee JM: Cervical arthroplasty: A success, failure, or both? Spine J 10:731-732, 2010.
43. Rietman CA, Hipp JA, Nguyen L, Esses S: Changes in segmental intervertebral motion adjacent to cervical arthrodesis: A prospective study. Spine (Phila pa 1976) 29:E221-E226, 2004.
44. 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.
45. Sell S, Willms R, Jany R, Esenwein S, Gaissmaier C, Martini F, et al: The suppression of heterotopic ossifications: radiation versus NSAID therapy-a prospective study. J Arthroplasty 13:854-859, 1998. (Pubitemid 29016791)
46. Smith GW, Robinson RA: The treatment of certain cervicalspine disorders by anterior removal of the intervertebral disc and interbody fusion. J Bone Joint Surg Am 40-A:607-624, 1958.
47. Swank ML, Lowery GL, Bhat AL, McDonough RF: Anterior cervical allograft arthrodesis and instrumentation: multilevel interbody grafting or strut graft reconstruction. Eur Spine J 6:138-143, 1997. (Pubitemid 27240148)
48. Upadhyaya CD, Wu JC, Trost G, Haid RW, Traynelis VC, Tay B, et al: Analysis of the three United States Food and Drug Administration investigational device exemption cervical arthroplasty trials. Clinical article. J Neurosurg Spine 16:216-228, 2012.
49. Zindrick M, Harris MB, Humphreys SC, O'Leary PT, Schneiderman G, Watters WC III, et al: Cervical disc arthroplasty. J Am Acad Orthop Surg 18:631-637, 2010.