Occurrence and clinical implications of heterotopic ossification after cervical disc arthroplasty with the Prestige LP Cervical Disc at 2 contiguous levels

View More View Less
  • 1 The Orthopedic Center of St. Louis, Missouri;
  • 2 Institute for Spinal Disorders, Cedars-Sinai Medical Center, Los Angeles, California;
  • 3 Wilderness Spine Services, Columbus, Georgia;
  • 4 Central Texas Spine Institute, Austin, Texas;
  • 5 Orthopedic Specialists, Allentown, Pennsylvania;
  • 6 Center for Sports Medicine & Orthopaedics, Chattanooga, Tennessee;
  • 7 SPIRITT Research, St. Louis, Missouri; and
  • 8 Medtronic, Memphis, Tennessee
Restricted access

Purchase Now

USD  $45.00

Spine - 1 year subscription bundle (Individuals Only)

USD  $369.00

JNS + Pediatrics + Spine - 1 year subscription bundle (Individuals Only)

USD  $600.00
Print or Print + Online

OBJECTIVE

The authors sought to assess the impact of heterotopic ossification (HO) on clinical outcomes and angular range of motion (ROM) after cervical disc arthroplasty (CDA) performed with the Prestige LP Cervical Disc (Prestige LP disc) at 2 levels.

METHODS

HO was assessed and graded from 0 to IV for increasing severity on lateral neutral radiographs at each visit in 209 patients who underwent implantation of Prestige LP discs at 2 cervical levels in a clinical trial with extended 10-year follow-up. ROM was compared by using HO grade, and clinical outcomes were compared between HO subgroups (grade 0–II vs III/IV) based on HO severity at 2 and 10 years after surgery.

RESULTS

The grade III/IV HO incidence at either or both index levels was 24.2% (48/198) at 2 years and 39.0% (57/146) at 10 years. No statistical difference was found in overall success; neurological success; or Neck Disability Index (NDI), neck pain, arm pain, or SF-36 Physical Component Summary (PCS) scores between the HO subgroups (grade 0–II vs III/IV) at either 2 or 10 years. The cumulative rate of possible implant-related adverse events (AEs) was higher in patients having grade III/IV HO at 2 years (56.3%) and 10 years (47.8%) compared with those having grade 0–II HO at 2 years (24.4%) and 10 years (17.9%), specifically in 2 subcategories: spinal events and HOs reported by the investigators. No statistical difference was found between the HO subgroups in possible implant-related serious AEs or secondary surgeries at the index or adjacent levels. The average angular ROMs at index levels were lower in subjects with higher-grade HO at 2 and 10 years. The average ROMs at the superior level were 8.8°, 6.6°, 3.2°, and 0.3°, respectively, for the HO grade 0/I, II, III, and IV groups at 10 years, and 7.9°, 6.2°, 3.7°, and 0.6°, respectively, at the inferior level.

CONCLUSIONS

Radiographically severe (grade III or IV) HO after CDA with the Prestige LP disc at 2 levels did not significantly affect efficacy or safety outcomes (severe AEs or secondary surgeries). However, severe HO, particularly grade IV HO, significantly limited ROM, as expected.

ABBREVIATIONS ACDF = anterior cervical discectomy and fusion; AE = adverse event; CDA = cervical disc arthroplasty; HO = heterotopic ossification; NDI = Neck Disability Index; PAS = postapproval study; Prestige LP disc = Prestige LP Cervical Disc; ROM = range of motion; SAE = serious AE; VAS = visual analog scale.

Spine - 1 year subscription bundle (Individuals Only)

USD  $369.00

JNS + Pediatrics + Spine - 1 year subscription bundle (Individuals Only)

USD  $600.00

Contributor Notes

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

INCLUDE WHEN CITING Published online March 13, 2020; DOI: 10.3171/2020.1.SPINE19816.

Disclosures The investigational device exemption and postapproval study were sponsored by Medtronic. The authors report the following: M. F. Gornet: consulting: Aesculap and Medtronic; stock ownership: Bonovo, International Spine & Orthopedic Institute, Nocimed, OuroBoros, and Paradigm Spine; royalties: Medtronic and RTI. T. H. Lanman: consulting: Medtronic, NuVasive, and Stryker; royalties: Stryker and Medtronic. J. K. Burkus: consulting: Medtronic and Zimmer-Biomet; royalties: Zimmer-Biomet; research support: Medtronic and NuVasive. R. G. Dryer: royalties: NuVasive and Globus Medical. J. R. McConnell: consulting: Globus Medical, DePuy Synthes, and IMSE; royalties: Globus Medical; stock ownership: Globus Medical; speakers bureau: Globus Medical and Zimmer-Biomet. S. D. Hodges: consulting: Medtronic. F. W. Schranck: stock ownership: Nocimed. G. Ma: employee: Medtronic.

  • 1

    Arnold PM, Anderson KK, Selim A, Dryer RF, Burkus JK: Heterotopic ossification following single-level anterior cervical discectomy and fusion: results from the prospective, multicenter, historically controlled trial comparing allograft to an optimized dose of rhBMP-2. J Neurosurg Spine 25:292302, 2016

    • Search Google Scholar
    • Export Citation
  • 2

    Brenke C, Scharf J, Schmieder K, Barth M: High prevalence of heterotopic ossification after cervical disc arthroplasty: outcome and intraoperative findings following explantation of 22 cervical disc prostheses. J Neurosurg Spine 17:141146, 2012

    • Search Google Scholar
    • Export Citation
  • 3

    Gao F, Mao T, Sun W, Guo W, Wang Y, Li Z, : An updated meta-analysis comparing artificial cervical disc arthroplasty (CDA) versus anterior cervical discectomy and fusion (ACDF) for the treatment of cervical degenerative disc disease (CDDD). Spine (Phila Pa 1976) 40:18161823, 2015

    • Search Google Scholar
    • Export Citation
  • 4

    Gornet MF, Burkus JK, Shaffrey ME, Argires PJ, Nian H, Harrell 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 23:558573, 2015

    • Search Google Scholar
    • Export Citation
  • 5

    Gornet MF, Burkus JK, Shaffrey ME, Schranck FW, Copay AG: Cervical disc arthroplasty: 10-year outcomes of the Prestige LP cervical disc at a single level. J Neurosurg Spine 31:317325, 2019

    • Search Google Scholar
    • Export Citation
  • 6

    Gornet MF, Lanman TH, Burkus JK, Dryer RF, McConnell JR, Hodges SD, : Two-level cervical disc arthroplasty versus anterior cervical discectomy and fusion: 10-year outcomes of a prospective, randomized investigational device exemption clinical trial. J Neurosurg Spine 31:508518, 2019

    • Search Google Scholar
    • Export Citation
  • 7

    Gornet MF, Lanman TH, Burkus JK, Hodges SD, McConnell JR, Dryer RF, : Cervical disc arthroplasty with the Prestige LP disc versus anterior cervical discectomy and fusion, at 2 levels: results of a prospective, multicenter randomized controlled clinical trial at 24 months. J Neurosurg Spine 26:653667, 2017

    • Search Google Scholar
    • Export Citation
  • 8

    Guérin P, Obeid I, Bourghli A, Meyrat R, Luc S, Gille O, : Heterotopic ossification after cervical disc replacement: clinical significance and radiographic analysis. A prospective study. Acta Orthop Belg 78:8086, 2012

    • Search Google Scholar
    • Export Citation
  • 9

    Kong L, Ma Q, Meng F, Cao J, Yu K, Shen Y: The prevalence of heterotopic ossification among patients after cervical artificial disc replacement: a systematic review and meta-analysis. Medicine (Baltimore) 96:e7163, 2017

    • Search Google Scholar
    • Export Citation
  • 10

    Lanman TH, Burkus JK, Dryer RG, Gornet MF, McConnell J, Hodges 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 27:719, 2017

    • Search Google Scholar
    • Export Citation
  • 11

    Lavelle WF, Riew KD, Levi AD, Florman JE: Ten-year outcomes of cervical disc replacement with the BRYAN cervical disc: results from a prospective, randomized, controlled clinical trial. Spine (Phila Pa 1976) 44:601608, 2019

    • Search Google Scholar
    • Export Citation
  • 12

    Lee SE, Chung CK, Jahng TA: Early development and progression of heterotopic ossification in cervical total disc replacement. J Neurosurg Spine 16:3136, 2012

    • Search Google Scholar
    • Export Citation
  • 13

    Leung C, Casey AT, Goffin J, Kehr P, Liebig K, Lind B, : Clinical significance of heterotopic ossification in cervical disc replacement: a prospective multicenter clinical trial. Neurosurgery 57:759763, 2005

    • Search Google Scholar
    • Export Citation
  • 14

    Mehren C, Suchomel P, Grochulla F, Barsa P, Sourkova P, Hradil J, : Heterotopic ossification in total cervical artificial disc replacement. Spine (Phila Pa 1976) 31:28022806, 2006

    • Search Google Scholar
    • Export Citation
  • 15

    Nunley PD, Cavanaugh DA, Kerr EJ III, Utter PA, Campbell PG, Frank KA, : Heterotopic ossification after cervical total disc replacement at 7 years—prevalence, progression, clinical implications, and risk factors. Int J Spine Surg 12:352361, 2018

    • Search Google Scholar
    • Export Citation
  • 16

    Suchomel P, Jurák L, Benes V III, Brabec R, Bradác O, Elgawhary S: Clinical results and development of heterotopic ossification in total cervical disc replacement during a 4-year follow-up. Eur Spine J 19:307315, 2010

    • Search Google Scholar
    • Export Citation
  • 17

    Tu TH, Wu JC, Huang WC, Guo WY, Wu CL, Shih YH, : Heterotopic ossification after cervical total disc replacement: determination by CT and effects on clinical outcomes. J Neurosurg Spine 14:457465, 2011

    • Search Google Scholar
    • Export Citation
  • 18

    Xu S, Liang Y, Zhu Z, Qian Y, Liu H: Adjacent segment degeneration or disease after cervical total disc replacement: a meta-analysis of randomized controlled trials. J Orthop Surg Res 13:244, 2018

    • Search Google Scholar
    • Export Citation
  • 19

    Yang W, Si M, Hou Y, Nie L: Superiority of 2-level total disk replacement using a cervical disk prosthesis versus anterior cervical diskectomy and fusion. Orthopedics 41:344350, 2018

    • Search Google Scholar
    • Export Citation
  • 20

    Yi S, Kim KN, Yang MS, Yang JW, Kim H, Ha Y, : Difference in occurrence of heterotopic ossification according to prosthesis type in the cervical artificial disc replacement. Spine (Phila Pa 1976) 35:15561561, 2010

    • Search Google Scholar
    • Export Citation
  • 21

    Zeng J, Liu H, Chen H, Rong X, Meng Y, Yang Y, : Effect of prosthesis width and depth on heterotopic ossification after cervical disc arthroplasty. Spine (Phila Pa 1976) 44:624628, 2019

    • Search Google Scholar
    • Export Citation
  • 22

    Zeng J, Liu H, Rong X, Wang B, Yang Y, Gao X, : Clinical and radiographic outcomes of cervical disc arthroplasty with Prestige-LP Disc: a minimum 6-year follow-up study. BMC Musculoskelet Disord 19:285, 2018

    • Search Google Scholar
    • Export Citation
  • 23

    Zhou HH, Qu Y, Dong RP, Kang MY, Zhao JW: Does heterotopic ossification affect the outcomes of cervical total disc replacement? A meta-analysis. Spine (Phila Pa 1976) 40:E332E340, 2015

    • Search Google Scholar
    • Export Citation

Metrics

All Time Past Year Past 30 Days
Abstract Views 98 98 35
Full Text Views 55 55 37
PDF Downloads 38 38 22
EPUB Downloads 0 0 0