PMID- 29662749
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220317
IS  - 2192-5682 (Print)
IS  - 2192-5690 (Electronic)
IS  - 2192-5682 (Linking)
VI  - 8
IP  - 2
DP  - 2018 Apr
TI  - Adverse Events Following Cervical Disc Arthroplasty: A Systematic Review.
PG  - 178-189
LID - 10.1177/2192568217720681 [doi]
AB  - STUDY DESIGN: Systematic review. OBJECTIVES: Cervical arthroplasty is an 
      increasingly popular treatment of cervical radiculopathy and myelopathy. An 
      understanding of the potential adverse events (AEs) is important to help both 
      clinicians and patients. We sought to provide a comprehensive systematic review 
      of the AEs reported in all randomized controlled trials (RCTs) of cervical disc 
      arthroplasty in an attempt to characterize the quality of reporting. METHODS: We 
      conducted a systematic review of MEDLINE and Web of Science for RCTs of cervical 
      disc arthroplasty reporting AEs. We reported the most frequently mentioned AEs, 
      including dysphagia/dysphonia, vascular compromise, dural injury, and infections. 
      We recorded the presence of industry funding and scored the quality of collection 
      methods and reporting of AEs. RESULTS: Of the 3734 identified articles, 29 
      articles met full inclusion criteria. The quality of AE reporting varied 
      significantly between studies, and a combined meta-analysis was not feasible. The 
      29 articles covered separate 19 RCTs. Eight studies were US Food and Drug 
      Administration (FDA) investigational device exemption (IDE) trials. Rates were 
      recorded for the following AEs: dysphagia/dysphonia (range = 1.3% to 27.2%), 
      vascular compromise (range = 1.1% to 2.4%), cervical wound infection (range = 
      1.2% to 22.5%), and cerebrospinal fluid leak (range = 0.8% to 7.1%). CONCLUSIONS: 
      There is a lack of consistency in reporting of AEs among RCTs of cervical 
      arthroplasty. FDA IDE trials scored better in AE event reporting compared to 
      other studies. Standardized definitions for AEs and standardized data collection 
      methodology are needed to improve future studies.
FAU - Xu, Jordan C
AU  - Xu JC
AUID- ORCID: 0000-0002-1471-232X
AD  - Case Western Reserve University, Cleveland, OH, USA.
FAU - Goel, Chandni
AU  - Goel C
AD  - Northeast Ohio Medical University, Rootstown, OH, USA.
FAU - Shriver, Michael F
AU  - Shriver MF
AD  - Case Western Reserve University, Cleveland, OH, USA.
FAU - Tanenbaum, Joseph E
AU  - Tanenbaum JE
AD  - Case Western Reserve University, Cleveland, OH, USA.
AD  - Cleveland Clinic, Cleveland, OH, USA.
FAU - Steinmetz, Michael P
AU  - Steinmetz MP
AD  - Cleveland Clinic, Cleveland, OH, USA.
FAU - Benzel, Edward C
AU  - Benzel EC
AD  - Cleveland Clinic, Cleveland, OH, USA.
FAU - Mroz, Thomas E
AU  - Mroz TE
AD  - Cleveland Clinic, Cleveland, OH, USA.
LA  - eng
GR  - T32 GM007250/GM/NIGMS NIH HHS/United States
GR  - TL1 TR000441/TR/NCATS NIH HHS/United States
GR  - TL1 TR002549/TR/NCATS NIH HHS/United States
PT  - Journal Article
PT  - Review
DEP - 20170815
PL  - England
TA  - Global Spine J
JT  - Global spine journal
JID - 101596156
PMC - PMC5898676
OTO - NOTNLM
OT  - adverse events
OT  - cervical disc arthroplasty
OT  - complications
OT  - industry funding
OT  - systematic review
COIS- Declaration of Conflicting Interests: The author(s) declared no potential 
      conflicts of interest with respect to the research, authorship, and/or 
      publication of this article.
EDAT- 2018/04/18 06:00
MHDA- 2018/04/18 06:01
PMCR- 2017/08/15
CRDT- 2018/04/18 06:00
PHST- 2018/04/18 06:00 [entrez]
PHST- 2018/04/18 06:00 [pubmed]
PHST- 2018/04/18 06:01 [medline]
PHST- 2017/08/15 00:00 [pmc-release]
AID - 10.1177_2192568217720681 [pii]
AID - 10.1177/2192568217720681 [doi]
PST - ppublish
SO  - Global Spine J. 2018 Apr;8(2):178-189. doi: 10.1177/2192568217720681. Epub 2017 
      Aug 15.