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Cervical arthroplasty: what does the labeling say?

Mazda K Turel1, Mena G Kerolus1, Owoicho Adogwa1

  • 1Department of Neurosurgery, Rush University Medical Center, Chicago, Illinois.

Neurosurgical Focus
|February 2, 2017
PubMed
Summary

This review compares 7 FDA-approved cervical disc replacements based on their labels. Prestige ST and Mobi-C showed superiority in key outcomes for single and two-level applications, respectively.

Keywords:
ACDF = anterior cervical discectomy and fusionFDA = Food and Drug AdministrationFSU = functional spinal unitFood and Drug AdministrationIDE = investigational device exemptionNDI = Neck Disability Indexanterior cervical discectomy and fusioncervical arthroplasty

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Area of Science:

  • Spine Surgery
  • Biomedical Engineering
  • Orthopedics

Background:

  • Cervical disc replacement offers an alternative to anterior cervical discectomy and fusion.
  • Understanding FDA-approved device labels is crucial for surgical decision-making.

Purpose of the Study:

  • To comprehensively review FDA-approved labels of 7 cervical disc replacements.
  • To compare the methodology, safety, and efficacy data of these devices.
  • To aid surgeons in selecting the best device based on specific treatment goals.

Main Methods:

  • Obtained FDA-approved labels for 7 artificial cervical discs from the FDA website.
  • Compared labels regarding statistical analysis, safety and efficacy data, and randomized controlled trials.
  • Examined single-level and two-level approvals, assessing primary and secondary endpoints.

Main Results:

  • For single-level use, Prestige ST, Prestige LP, Bryan, and Secure-C showed superiority in overall success.
  • Prestige ST demonstrated superiority in neurological success, revision surgery, and overall success.
  • For two-level use, Prestige LP and Mobi-C showed superiority in NDI, secondary surgery, and overall success.

Conclusions:

  • This analysis provides a comprehensive comparison of 7 US-approved artificial cervical discs.
  • It contrasts device outcomes with anterior cervical discectomy and fusion.
  • Surgeons can use this information to answer patient questions and discuss device options.