Cervical arthroplasty data continues to be favorable from 2 to 10 years

Kudos to Sasso et al. for their diligence in presenting the 7- and 10-year clinical results of single-level Bryan Disc cervical arthroplasty and anterior cervical discectomy and fusion (ACDF). Level 1, prospective outcome data on 47 patients from a single center of a multicenter FDA IDE trial were assessed with regard to neck disability index (NDI), visual analog scale (VAS) neck and arm pain scores, and reoperation. Data was available for 89% (42/47) of patients at 10 years. At 10 years both groups had similar, significant reduction in VAS neck and arm pain scores. NDI scores were also improved in both cervical arthroplasty and ACDF groups, but the arthroplasty group had a statistically significant difference in improvement as compared to the ACDF group. At 10 years, reoperations were performed in 9% (2/22) of the arthroplasty patients and 32% (8/25) of the ACDF patients.

ACDF is a frequently performed and familiar surgical procedure developed in the 1950s for the treatment of symptomatic cervical radiculopathy and/or myelopathy caused by degenerative disc disease (1). Through the years the procedure has been modified, and generally the surgical results are considered by most surgeons to be good to excellent. There are two main procedure-specific complications associated with ACDF: pseudarthrosis and adjacent level degeneration (2). ACDF by design eliminates the natural motion between vertebral segments, and has been shown to induce hypermobility and increase stresses at adjacent levels (3-7). Disc arthroplasty was developed to preserve natural spinal kinematics while providing mechanical stabilization after neural decompression and discectomy.

Cervical total disc replacement (TDR) followed shortly after lumbar disc replacement and was introduced in Europe in the 1990s. Early 2000s IDE studies and approvals in the US included the Prestige ST (Medtronic) (8), ProDisc-C (DePuy Synthes) (9) and the Bryan Disc (Medtronic) (10) for the treatment of single level cervical degenerative disc disease. This was shortly followed by the Secure-C (Globus Medical) (11) and PCM (NuVasive) (12) for single level disc disease, and subsequently the Mobi-C (LDR-Zimmer Biomet) (13,14) and the Prestige LP (Medtronic) (15,16) for both one- and two-level disc disease. These US, FDA IDE trials compared TDR to ACDF using allograft and plate in a prospective, randomized fashion measuring standardized outcome and producing Level 1 evidence in over 2,500 patients at over 100 study sites.

Two-year to ten-year data indicate that both TDR and ACDF are effective treatments for symptomatic cervical degenerative disc disease with regard to neck and arm pain, neurological function, and are associated with low complication rates. There is a trend for better early and long-term results with regard to VAS neck pain, arm pain and NDI scores in the TDR patients (13,14,17,18). Treated level range of motion was maintained at approximately 6–10 degrees of flexion/extension and 5 degrees of lateral bending in the TDR patients and eliminated in the ACDF patients (8-18).

Adjacent level degeneration is often considered controversial but has been shown to be less in TDR as compared to ACDF in several studies (11,14,19,20) and similar in other studies (21). Reoperation rates for index level failure or symptomatic adjacent level degeneration have been found to be significantly higher in both one- and two-level ACDF patients as compared to the TDR patients ranging from 3–5% in the TDR group to 14–17% in the ACDF group in studies ranging 2–7 years (11,15,18,22-24) Heterotopic ossification (HO) is a unique complication associated with arthroplasty which appears to increase over time. Rates vary from 0–43% based on the precise definition utilized. Complete HO or solid fusion was seen in approximately 11% of TDR patients in some studies at 7 years (16,24,25). Interestingly, this unique complication to arthroplasty would be considered a successful ACDF surgery.

Both TDR and ACDF are effective treatments with regard to neck and arm pain, neurological function, and complication rates. In appropriate patients, TDR may be the new gold standard in anterior cervical spine surgery as it has been shown to be associated with significantly better pain scores, maintained ROM, less adjacent level degeneration, and less subsequent surgery than ACDF from 7 to 10 years.

Acknowledgements

Funding: None.

Footnote

Provenance and Peer Review: This article was commissioned and reviewed by the Section Editor Ai-Min Wu (Department of Spinal Surgery, Zhejiang Spinal Surgery Centre, Orthopaedic Hospital, The Second Affiliated Hospital and Yuying Children’s Hospital of Wenzhou Medical University, The Key Orthopaedic Laboratory in Zhejiang Province, Wenzhou, China).

Conflicts of Interest: The author has completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/amj.2017.05.20). The author has no conflicts of interest to declare.

Ethical Statement: The author is accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

References

1. Smith GW, Robinson RA. The treatment of certain cervical-spine disorders by anterior removal of the intervertebral disc and interbody fusion. J Bone Joint Surg Am 1958;40-A:607-24. [Crossref] [PubMed]
2. Hilibrand AS, Carlson GD, Palumbo MA, et al. Radiculopathy and myelopathy at segments adjacent to the site of a previous anterior cervical arthrodesis. J Bone Joint Surg Am 1999;81:519-28. [Crossref] [PubMed]
3. Fuller DA, Kirkpatrick JS, Emery SE, et al. A kinematic study of the cervical spine before and after segmental arthrodesis. Spine (Phila Pa 1976) 1998;23:1649-56. [Crossref] [PubMed]
4. Park DK, Lin EL, Phillips FM. Index and adjacent level kinematics after cervical disc replacement and anterior fusion: in vivo quantitative radiographic analysis. Spine (Phila Pa 1976) 2011;36:721-30. [Crossref] [PubMed]
5. Dmitriev AE, Cunningham BW, Hu N, et al. Adjacent level intradiscal pressure and segmental kinematics following a cervical total disc arthroplasty: an in vitro human cadaveric model. Spine (Phila Pa 1976) 2005;30:1165-72. [Crossref] [PubMed]
6. Elsawaf A, Mastronardi L, Roperto R, et al. Effect of cervical dynamics on adjacent segment degeneration after anterior cervical fusion with cages. Neurosurg Rev 2009;32:215-24; discussion 224. [Crossref] [PubMed]
7. Matsunaga S, Kabayama S, Yamamoto T, et al. Strain on intervertebral discs after anterior cervical decompression and fusion. Spine (Phila Pa 1976) 1999;24:670-5. [Crossref] [PubMed]
8. Mummaneni PV, Burkus JK, Haid RW, et al. Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial. J Neurosurg Spine 2007;6:198-209. [Crossref] [PubMed]
9. Murrey D, Janssen M, Delamarter R, 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 2009;9:275-86. [Crossref] [PubMed]
10. Heller JG, Sasso RC, Papadopoulos SM, 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) 2009;34:101-7. [Crossref] [PubMed]
11. Vaccaro A, Beutler W, Peppelman WA, et al. Clinical outcomes with selectively constrained SECURE-C cervical disc arthroplasty Two-Year results from a prospectivei, randomized, controlled, multicenter investigational device exemption study. Spine (Phila Pa 1976) 2013;38:2227-39. [Crossref] [PubMed]
12. Phillips FM, Geisler FH, Gilder KM, et al. 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) 2015;40:674-83. [Crossref] [PubMed]
13. Hisey MS, Zigler JE, Jackson R, et al. 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 2016;10:10. [Crossref] [PubMed]
14. Davis RJ, Nunley PD, Kim KD, et al. Two-level total disc replacement with Mobi-C cervical artificial disc versus anterior discectomy and fusion: a prospective, randomized, controlled multicenter clinical trial with 4-year follow-up results. J Neurosurg Spine 2015;22:15-25. [Crossref] [PubMed]
15. Gornet MF, Burkus JK, Shaffrey ME, et al. Cervical Disc Arthroplasty with Prestige LP Disc Versus Anterior Cervical Discectomy and Fusion: Seven-Year Outcomes. Int J Spine Surg 2016;10:24. [Crossref] [PubMed]
16. Lanman TH, Burkus JK, Dryer RG, et al. 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 2017;1-13. [Epub ahead of print]. [Crossref] [PubMed]
17. Burkus JK, Haid RW, Traynelis VC, et al. Long-clinical and radiographic outcomes of cervical disc replacement with the Prestige disc: results from a prospective randomized controlled clinical trial. J Neurosurg Spine 2010;13:308-18. [Crossref] [PubMed]
18. Zigler JE, Delamarter R, Murrey D, et al. ProDisc-C and ACDF as surgical treatment for single level cervical symptomatic degenerative disc disease: Five-year results of an FDA study. Spine (Phila Pa 1976) 2013;38:203-9. [Crossref] [PubMed]
19. Coric D, Nunley P, Guyer RD, 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 2011;15:348-58. [Crossref] [PubMed]
20. Wu TK, Wang BY, Meng Y, et al. Multilevel cervical disc replacement versus multilevel anterior discectomy and fusion: A meta-analysis. Medicine (Baltimore) 2017;96:e6503. [Crossref] [PubMed]
21. Riew KD, Schenk-Kisser JM, Skelly AC. Adjacent segment disease and C-ADR: promises fulfilled? Evid Based Spine Care J 2012;3:39-46. [Crossref] [PubMed]
22. Janssen ME, Zigler JE, Spivak JM, et al. 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 2015;97:1738-47. [Crossref] [PubMed]
23. Jackson RJ, Davis RJ, Hoffman GA, et al. Subsequent surgery rates after cervical total disc replacement using a Mobi-C Cervical Disc Prosthesis versus anterior cervical discectomy and fusion: a prospective randomized clinical trial with 5-year follow-up. J Neurosurg Spine 2016;24:734-45. [Crossref] [PubMed]
24. Burkus JK, Traynelis VC, Haid RW Jr, et al. Clinical and radiographic analysis of an artificial cervical disc: 7-year follow-up from the Prestige prospective randomized controlled clinical trial. J Neurosurg Spine 2014;21:516-28. [Crossref] [PubMed]
25. Radcliff K, Davis RJ, Hisey MS, et al. Long-term Evaluation of Cervical Disc Arthroplasty with the Mobi-C Cervical Disc: A Randomized, Prospective, Multicenter Clinical Trial with Seven-Year Follow-up. Int J Spine Surg 2017; [Epub ahead of print].