Long-term clinical experience with selectively constrained SECURE-C cervical artificial disc for 1-level cervical disc disease: Results from seven-year follow-up of a prospective, randomized, controlled investigational device exemption clinical trial

Alexander Vaccaro, William Beutler, Walter Peppelman, Joseph Marzluff, Andrew Mugglin, Prem S. Ramakrishnan, Jacqueline Myer, Kelly J. Baker

Research output: Contribution to journalArticle

7 Scopus citations

Abstract

Background: This research was initiated to compare the long-term clinical safety and effectiveness of the selectively constrained SECURE-C (Globus Medical, Audubon, Pennsylvania) Cervical Artificial Disc to anterior cervical discectomy and fusion (ACDF). To preserve segmental motion, cervical total disc replacement (CTDR) was developed as an alternative to ACDF. Current CTDR designs incorporate constrained and unconstrained metal-onmetal or metal-on-polymer articulation with various means of fixation. Methods: Eighteen investigational sites participated in this prospective clinical trial; 380 patients were enrolled and treated in the investigational device exemption study. The first 5 patients treated at each site were nonrandomized and received the investigational SECURE-C device. Patients were randomized, treated surgically, and evaluated postoperatively at 6 weeks, 3 months, 6 months, 12 months, 24 months, and annually thereafter through 84 months postoperative. Results: Overall results for the randomized cohorts demonstrated statistical superiority of the investigational SECURE-C group over the control ACDF group at 84 months postoperative. SECURE-C showed clinically significant improvement in pain and function in terms of neck disability index and visual analog scale scores, and superiority in patient satisfaction was also achieved for patients treated with SECURE-C. Conclusion: Clinical study results indicated that the selectively constrained SECURE-C Cervical Artificial Disc is as safe and effective as ACDF. Long-termresults from the Post Approval Study demonstrated that SECURE-C is statistically superior to ACDF in terms of overall success and patient satisfaction. Lower rates of subsequent index-level surgeries and device-related adverse events were observed in the SECURE-C group than in the ACDF group. The long-term, level 1 clinical evidence presented here is consistent with other reports supporting the safety and efficacy of cervical arthroplasty, and furthers advocacy for motion preservation as a viable alternative to fusion.

Original languageEnglish (US)
Pages (from-to)377-387
Number of pages11
JournalInternational Journal of Spine Surgery
Volume12
Issue number3
DOIs
StatePublished - Jun 1 2018
Externally publishedYes

Keywords

  • 84 months
  • Adverse events
  • Anterior cervical discectomy and fusion
  • Bayesian
  • Cervical
  • Cervical disc disease
  • Clinical trial
  • Follow-up
  • Motion preservation
  • Noninferiority
  • Selectively constrained
  • Superiority
  • Symptomatic
  • Total disc arthroplasty
  • Total disc replacement

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