Review
. 2021 Jul 29;13(7):e16739.
doi: 10.7759/cureus.16739.
eCollection 2021 Jul.
Affiliations
Affiliations
- 1 Neurosurgery, Desert Regional Medical Center, Palm Springs, USA.
- 2 College of Medicine, University of Kentucky, Lexington, USA.
- 3 Osteopathic Medicine, Midwestern University Arizona College of Osteopathic Medicine, Glendale, USA.
- 4 Medicine, Oakland University William Beaumont School of Medicine, Rochester, USA.
- 5 School of Medicine, University of Texas Medical Branch, Galveston, USA.
Item in Clipboard
Review
Brian Fiani et al.
Cureus.
.
Display options
Format
. 2021 Jul 29;13(7):e16739.
doi: 10.7759/cureus.16739.
eCollection 2021 Jul.
Affiliations
- 1 Neurosurgery, Desert Regional Medical Center, Palm Springs, USA.
- 2 College of Medicine, University of Kentucky, Lexington, USA.
- 3 Osteopathic Medicine, Midwestern University Arizona College of Osteopathic Medicine, Glendale, USA.
- 4 Medicine, Oakland University William Beaumont School of Medicine, Rochester, USA.
- 5 School of Medicine, University of Texas Medical Branch, Galveston, USA.
Item in Clipboard
Display options
Format
Abstract
Spinal disc arthroplasty (SDA) has been a rising alternative to fusion for the treatment of degenerative disc disease (DDD). This review aims to provide an overview of the timeline, approvals, and limitations of SDA through analysis of U.S. Food and Drug Administration (FDA)-approved trials. Clinical studies have shown more successful outcomes when comparing cervical disc arthroplasty (CDA) with anterior cervical decompression and fusion, with the key benefits of decreased risk of nerve root compression and adjacent disc disease. CDA is currently approved by the FDA for one- and two-level disc pathologies. However, there are no approved trials for three-level or more cervical pathologies. The FDA approved its usage for the treatment of one-level lumbar disc pathologies in 2007 and recently approved two-level disc pathologies in 2020. Thoracic SDA has not been approved by the FDA, and there are no currently occurring clinical trials. While multilevel SDA has been approved in the cervical and lumbar spine, it has not been approved in more than two adjacent vertebral levels. Based on these clinical studies, future research is needed to compare the success of SDA for three-level or more disc pathologies. There have been recent publications showing promising results, though no FDA-approved clinical trials exist. Furthermore, a hybrid construct has been a recent surgical method to treat multilevel DDD. In this approach, arthroplasty and fusion techniques are combined in alternating fashion at adjacent levels to treat two- and three-level disc disease. Hybrid arthroplasty compared with SDA is currently being studied in clinical trials. As such, long-term research with FDA-approved clinical trials is needed to understand the benefits and limitations of different approaches in the treatment of DDD.
Keywords:
adjacent segment disease; artificial disc; cervical disc degeneration; degenerative spine disease; disc arthroplasty; hybrid; interbody device; lumbar disc degeneration; pseudoarthrosis; range of motion.
Copyright © 2021, Fiani et al.
Conflict of interest statement
The authors have declared that no competing interests exist.
Similar articles
-
Is cervical disc arthroplasty good for congenital cervical stenosis?
Chang PY, Chang HK, Wu JC, Huang WC, Fay LY, Tu TH, Wu CL, Cheng H.
Chang PY, et al.
J Neurosurg Spine. 2017 May;26(5):577-585. doi: 10.3171/2016.10.SPINE16317. Epub 2017 Mar 10.
J Neurosurg Spine. 2017.PMID: 28291414
-
Artificial discs for lumbar and cervical degenerative disc disease -update: an evidence-based analysis.
Medical Advisory Secretariat.
Medical Advisory Secretariat.
Ont Health Technol Assess Ser. 2006;6(10):1-98. Epub 2006 Apr 1.
Ont Health Technol Assess Ser. 2006.PMID: 23074480
Free PMC article. -
Two-level cervical disc arthroplasty versus anterior cervical discectomy and fusion: 10-year outcomes of a prospective, randomized investigational device exemption clinical trial.
Gornet MF, Lanman TH, Burkus JK, Dryer RF, McConnell JR, Hodges SD, Schranck FW.
Gornet MF, et al.
J Neurosurg Spine. 2019 Jun 21:1-11. doi: 10.3171/2019.4.SPINE19157. Online ahead of print.
J Neurosurg Spine. 2019.PMID: 31226684
-
Rate of Adjacent Segment Degeneration of Cervical Disc Arthroplasty Versus Fusion Meta-Analysis of Randomized Controlled Trials.
Luo J, Wang H, Peng J, Deng Z, Zhang Z, Liu S, Wang D, Gong M, Tang S.
Luo J, et al.
World Neurosurg. 2018 May;113:225-231. doi: 10.1016/j.wneu.2018.02.113. Epub 2018 Feb 28.
World Neurosurg. 2018.PMID: 29499425
Review.
-
Anterior cervical discectomy and fusion (ACDF) versus cervical disc arthroplasty (CDA) for two contiguous levels cervical disc degenerative disease: a meta-analysis of randomized controlled trials.
Zou S, Gao J, Xu B, Lu X, Han Y, Meng H.
Zou S, et al.
Eur Spine J. 2017 Apr;26(4):985-997. doi: 10.1007/s00586-016-4655-5. Epub 2016 Jun 17.
Eur Spine J. 2017.PMID: 27314663
Review.
References
-
-
Premarket Approval (PMA) [Jun;2021 ];https://www.fda.gov/medical-devices/premarket-submissions/premarket-appr… 2021
-
-
-
Neurological complications of lumbar artificial disc replacement and comparison of clinical results with those related to lumbar arthrodesis in the literature: results of a multicenter, prospective, randomized investigational device exemption study of Charité intervertebral disc. Geisler FH, Blumenthal SL, Guyer RD, McAfee PC, Regan JJ, Johnson JP, Mullin B. J Neurosurg Spine. 2004;1:143–154.
–
PubMed
-
-
-
The Prestige cervical disc replacement. Traynelis VC. Spine J. 2004;4:310–314.
–
PubMed
-
Cite