Cervical disc arthroplasty: 10-year outcomes of the Prestige LP cervical disc at a single level

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Food and Drug Administration–approved investigational device exemption (IDE) studies have provided level I evidence supporting cervical disc arthroplasty (CDA) as a safe and effective alternative to anterior cervical discectomy and fusion (ACDF). Long-term CDA outcomes continue to be evaluated. Here, the authors present outcomes at 10 years postoperatively for the single-level CDA arm of an IDE study (postapproval study).


The primary endpoint was overall success, a composite variable composed of five criteria: 1) Neck Disability Index score improvement ≥ 15 points; 2) maintenance or improvement in neurological status; 3) no decline in anterior or posterior functional spinal unit (FSU) height of more than 2 mm compared to 6 weeks postoperatively; 4) no serious adverse event (AE) caused by the implant or the implant and the surgical procedure; and 5) no additional surgery classified as a failure. Additional safety and effectiveness measures included numeric rating scales for neck pain and arm pain, SF-36 quality-of-life physical and mental components, patient satisfaction, range of motion, and AEs.


From the reported assessments at 7 years postoperatively to the 10-year postoperative follow-up, the scores for all patient-reported outcomes, rate of overall success (without FSU), and proportion of patients at least maintaining their neurological function remained stable for the CDA group. Nine patients had secondary surgery at the index level, increasing the secondary surgery cumulative rate from 6.6% to 10.3%. In that same time frame, four patients experienced a serious implant or implant/surgical procedure–related AE, for a 10-year cumulative rate of 7.8%. Seven patients had any second surgery at adjacent levels, for a 10-year cumulative rate of 13.8%. Average angular motion at both the index and adjacent levels was well maintained without creating hypermobility. Class IV heterotopic ossification increased from 1.2% at 2 years to 4.6% at 7 years and 9.0% at 10 years. Patient satisfaction was > 90% at 10 years.


CDA remained safe and effective out to 10 years postoperatively, with results comparable to 7-year outcomes and with high patient satisfaction.

Clinical trial registration no.: NCT00667459 (clinicaltrials.gov)

ABBREVIATIONS ACDF = anterior cervical discectomy and fusion; AE = adverse event; ASD = adjacent segment disease; CDA = cervical disc arthroplasty; FDA = Food and Drug Administration; FSU = functional spinal unit; HO = heterotopic ossification; IDE = investigational device exemption; MCS = Mental Component Summary; NDI = Neck Disability Index; PCS = Physical Component Summary.

Article Information

Correspondence Matthew F. Gornet: The Orthopedic Center of St. Louis, St. Louis, MO. mfgspine@gmail.com.

INCLUDE WHEN CITING Published online May 10, 2019; DOI: 10.3171/2019.2.SPINE1956.

Disclosures The investigational device exemption study was sponsored by Medtronic (Memphis, TN). The authors report the following potential or perceived conflicts: Dr. Gornet: consulting: Aesculap and Medtronic; stock ownership: Bonovo, International Spine & Orthopedic Institute, LLC, Nocimed, OuroBoros, and Paradigm Spine; royalties: Medtronic and RTI. Dr. Burkus: consulting: NuVasive; royalties: Zimmer-Biomet. Ms. Schranck: stock ownership: Nocimed.

© AANS, except where prohibited by US copyright law.



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    Angular motion at the index level. Patient-reported outcomes (NDI, neck pain, arm pain, SF-36 PCS, SF-36 MCS): scores and percent of patients achieving success. For the NDI, success was defined as ≥ 15 points’ improvement; for all other measures, success was maintenance or improvement of preoperative status. The clinical trial ACDF control group data are also shown out to 7 years.

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    Patient satisfaction with surgery and outcomes of treatment (percent of patients). The clinical trial ACDF control group data are also shown out to 7 years.

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    Flexion-extension radiographs from the same patient preoperatively (1st row) and postoperatively at 2, 5, 7, and 10 years (2nd to 5th rows, respectively).


  • 1

    Burkus JKTraynelis VCHaid RW JrMummaneni PV: Clinical and radiographic analysis of an artificial cervical disc: 7-year follow-up from the Prestige prospective randomized controlled clinical trial: clinical article. J Neurosurg Spine 21:5165282014

  • 2

    Buttermann GR: Anterior cervical discectomy and fusion outcomes over 10 years: a prospective study. Spine (Phila Pa 1976) 43:2072142018

  • 3

    Cavanaugh DANunley PDKerr EJ IIIWerner DJJawahar A: Delayed hyper-reactivity to metal ions after cervical disc arthroplasty: a case report and literature review. Spine (Phila Pa 1976) 34:E262E2652009

  • 4

    Chang KEPham MHHsieh PC: Adjacent segment disease requiring reoperation in cervical total disc arthroplasty: a literature review and update. J Clin Neurosci 37:20242017

  • 5

    Cloward RB: Vertebral body fusion for ruptured cervical discs. Am J Surg 98:7227271959

  • 6

    Coric DNunley PDGuyer RDMusante DCarmody CNGordon CR: 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 15:3483582011

  • 7

    Dejaegher JWalraevens Jvan Loon JVan Calenbergh FDemaerel PGoffin J: 10-year follow-up after implantation of the Bryan Cervical Disc Prosthesis. Eur Spine J 26:119111982017

  • 8

    Fan HWu SWu ZWang ZGuo Z: Implant failure of Bryan cervical disc due to broken polyurethane sheath: a case report. Spine (Phila Pa 1976) 37:E814E8162012

  • 9

    Gornet MFBurkus JKShaffrey MEArgires PJNian HHarrell FE Jr: Cervical disc arthroplasty with PRESTIGE LP disc versus anterior cervical discectomy and fusion: a prospective, multicenter investigational device exemption study. J Neurosurg Spine 23:5585732015

  • 10

    Gornet MFBurkus JKShaffrey MENian HHarrell FE Jr: Cervical disc arthroplasty with Prestige LP disc versus anterior cervical discectomy and fusion: seven-year outcomes. Int J Spine Surg 10:242016

  • 11

    Gornet MFSingh VSchranck FWSkipor AKJacobs JJ: Serum metal concentrations in patients with titanium ceramic composite cervical disc replacements. Spine (Phila Pa 1976) 42:3663712017

  • 12

    Guérin PObeid IBourghli AMeyrat RLuc SGille O: Heterotopic ossification after cervical disc replacement: clinical significance and radiographic analysis. A prospective study. Acta Orthop Belg 78:80862012

  • 13

    Guyer RDShellock JMacLennan BHanscom DKnight RQMcCombe P: Early failure of metal-on-metal artificial disc prostheses associated with lymphocytic reaction: diagnosis and treatment experience in four cases. Spine (Phila Pa 1976) 36:E492E4972011

  • 14

    Hacker FMBabcock RMHacker RJ: Very late complications of cervical arthroplasty: results of 2 controlled randomized prospective studies from a single investigator site. Spine (Phila Pa 1976) 38:222322262013

  • 15

    Harrod CCHilibrand ASFischer DJSkelly AC: Adjacent segment pathology following cervical motion-sparing procedures or devices compared with fusion surgery: a systematic review. Spine (Phila Pa 1976) 37 (22 Suppl):S96S1122012

  • 16

    Hermansen AHedlund RVavruch LPeolsson A: A comparison between the carbon fiber cage and the Cloward procedure in cervical spine surgery: a ten- to thirteen-year follow-up of a prospective randomized study. Spine (Phila Pa 1976) 36:9199252011

  • 17

    Hisey MSZigler JEJackson RNunley PDBae HWKim KD: Prospective, randomized comparison of one-level Mobi-C cervical total disc replacement vs. anterior cervical discectomy and fusion: results at 5-year follow-up. Int J Spine Surg 10:102016

  • 18

    Janssen MEZigler JESpivak JMDelamarter RBDarden BV IIKopjar B: ProDisc-C total disc replacement versus anterior cervical discectomy and fusion for single-level symptomatic cervical disc disease: seven-year follow-up of the prospective randomized U.S. Food and Drug Administration Investigational Device Exemption Study. J Bone Joint Surg Am 97:173817472015

  • 19

    Kim SHChung YSRopper AEMin KHAhn TKWon KS: Bone loss of the superior adjacent vertebral body immediately posterior to the anterior flange of Bryan cervical disc. Eur Spine J 24:287228792015

  • 20

    Lanman THBurkus JKDryer RGGornet MFMcConnell JHodges SD: Long-term clinical and radiographic outcomes of the Prestige LP artificial cervical disc replacement at 2 levels: results from a prospective randomized controlled clinical trial. J Neurosurg Spine 27:7–192017

  • 21

    Lavelle WFRiew KDLevi AFlorman JE: 10-year outcomes of cervical disc replacement with the BRYAN® cervical disc: results from a prospective, randomized, controlled clinical trial. Spine (Phila Pa 1976) 44:6016082019

  • 22

    Le HThongtrangan IKim DH: Historical review of cervical arthroplasty. Neurosurg Focus 17(3):E12004

  • 23

    Lee SEChung CKJahng TA: Early development and progression of heterotopic ossification in cervical total disc replacement. J Neurosurg Spine 16:31362012

  • 24

    Lehman RBevevino AJBrewer DDSkelly ACAnderson PA: A systematic review of cervical artificial disc replacement wear characteristics and durability. Evid Based Spine Care J 3 (Suppl 1):31382012

  • 25

    Mehren CHeider FSiepe CJZillner BKothe RKorge A: Clinical and radiological outcome at 10 years of follow-up after total cervical disc replacement. Eur Spine J 26:244124492017

  • 26

    Mehren CSuchomel PGrochulla FBarsa PSourkova PHradil J: Heterotopic ossification in total cervical artificial disc replacement. Spine (Phila Pa 1976) 31:280228062006

  • 27

    Nunley PDCoric DFrank KAStone MB: Cervical disc arthroplasty: current evidence and real-world application. Neurosurgery 83:108711062018

  • 28

    Phillips FMGeisler FHGilder KMReah CHowell KMMcAfee PC: Long-term outcomes of the US FDA IDE prospective, randomized controlled clinical trial comparing PCM cervical disc arthroplasty with anterior cervical discectomy and fusion. Spine (Phila Pa 1976) 40:6746832015

  • 29

    Pointillart VCastelain JECoudert PCawley DTGille OVital JM: Outcomes of the Bryan cervical disc replacement: fifteen year follow-up. Int Orthop 42:8518572018

  • 30

    Radcliff KCoric DAlbert T: Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial. J Neurosurg Spine 25:2132242016

  • 31

    Riew KDSchenk-Kisser JMSkelly AC: Adjacent segment disease and C-ADR: promises fulfilled? Evid Based Spine Care J 3 (Suppl 1):39462012

  • 32

    Sasso RCAnderson PARiew KDHeller JG: Results of cervical arthroplasty compared with anterior discectomy and fusion: four-year clinical outcomes in a prospective, randomized controlled trial. J Bone Joint Surg Am 93:168416922011

  • 33

    Sasso WRSmucker JDSasso MPSasso RC: Long-term clinical outcomes of cervical disc arthroplasty: a prospective, randomized, controlled trial. Spine (Phila Pa 1976) 42:2092162017

  • 34

    Singh VSkipor AKSelim AAJacobs JJ: Chromium and nickel concentrations in subjects with a stainless steel metal-on-metal cervical disc arthroplasty: results from a prospective longitudinal study with 7 years follow-up. Int J Spine Surg 12:4604682018

  • 35

    Smith GWRobinson RA: The treatment of certain cervical-spine disorders by anterior removal of the intervertebral disc and interbody fusion. J Bone Joint Surg Am 40-A:6076241958

  • 36

    Tumialán LMGluf WM: Progressive vertebral body osteolysis after cervical disc arthroplasty. Spine (Phila Pa 1976) 36:E973E9782011

  • 37

    Vaccaro ABeutler WPeppelman WMarzluff JMHighsmith JMugglin A: Clinical outcomes with selectively constrained SECURE-C cervical disc arthroplasty: two-year results from a prospective, randomized, controlled, multicenter investigational device exemption study. Spine (Phila Pa 1976) 38:222722392013

  • 38

    Verma KGandhi SDMaltenfort MAlbert TJHilibrand ASVaccaro AR: Rate of adjacent segment disease in cervical disc arthroplasty versus single-level fusion: meta-analysis of prospective studies. Spine (Phila Pa 1976) 38:225322572013

  • 39

    Vernon HMior S: The Neck Disability Index: a study of reliability and validity. J Manipulative Physiological Ther 14:4094151991 (Erratum in J Manipulative Physiol Ther 15:following 1992)

  • 40

    Yang SDZhu YBYan SZDi JYang DLDing WY: Anterior cervical discectomy and fusion surgery versus total disc replacement: a comparative study with minimum of 10-year follow-up. Sci Rep 7:164432017

  • 41

    Zhao YZhang YSun YPan SZhou FLiu Z: Application of cervical arthroplasty with Bryan cervical disc: 10-year follow-up results in China. Spine (Phila Pa 1976) 41:1111152016




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