PMID- 31970051
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220412
IS  - 2211-4599 (Print)
IS  - 2211-4599 (Electronic)
IS  - 2211-4599 (Linking)
VI  - 13
IP  - 6
DP  - 2019 Dec
TI  - One-Level Versus 2-Level Treatment With Cervical Disc Arthroplasty or Fusion: 
      Outcomes Up to 7 Years.
PG  - 551-560
LID - 10.14444/6076 [doi]
AB  - BACKGROUND: Anterior cervical discectomy and fusion (ACDF) and cervical disc 
      arthroplasty (CDA) have been used to treat degenerative disc disease at single as 
      well as multiple cervical levels. This study compares the safety and efficacy of 
      1-level versus 2-level CDA and ACDF. METHODS: In total, 545 and 397 patients with 
      degenerative disc disease were studied in 1-level and 2-level Food and Drug 
      Administration (FDA)-approved clinical trials, respectively: CDA (n = 280 and 
      209), ACDF (n = 265 and 188). Data from these studies were used to compare 1- 
      versus 2-level procedures: the propensity score method was used to adjust for 
      potential confounding effects, and adjusted mean outcome safety and efficacy 
      scores at 2 and 7 years postsurgery were compared between 1-level and 2-level 
      procedures within treatment type. RESULTS: One-level and 2-level procedures had 
      similar rates of improvement in overall success and patient-reported outcomes 
      scores for both CDA and ACDF. There were no statistical differences in rates of 
      implant-related adverse events (AEs) or serious implant-related AEs between 
      1-level and 2-level CDA. The 7-year rate of implant-related AEs was higher for 
      2-level than 1-level ACDF (27.7% vs 18.9%, P </= .036), though the rates of serious 
      implant-related AEs between ACDF groups did not differ significantly. Secondary 
      surgery rates were not statistically different between 1-level and 2-level 
      procedures (CDA or ACDF) at the index or adjacent levels at 2 or 7 years. Grade 
      IV heterotopic ossification at 7 years was reported in 4.6% of 1-level CDA 
      patients and 8.6%/7.3% at the superior/inferior levels, respectively, of 2-level 
      CDA patients. CONCLUSIONS: One- and 2-level CDA appear equally safe and effective 
      in the treatment of cervical degenerative disc disease. Two-level ACDF appears to 
      be as effective as 1-level ACDF but with a higher rate of some AEs at long-term 
      follow-up. LEVEL OF EVIDENCE: 2. CLINICAL TRIALS: clinicaltrials.gov: 
      NCT00667459, NCT00642876, and NCT00637156.
CI  - (c)International Society for the Advancement of Spine Surgery 2019.
FAU - Gornet, Matthew F
AU  - Gornet MF
AD  - Orthopedic Center of St Louis, St Louis, Missouri.
FAU - Lanman, Todd H
AU  - Lanman TH
AD  - California Spine Group, Century City Hospital, Los Angeles, California.
FAU - Burkus, J Kenneth
AU  - Burkus JK
AD  - Wilderness Spine Services, Columbus, Georgia.
FAU - Hodges, Scott D
AU  - Hodges SD
AD  - Center for Sports Medicine and Orthopedics, Chattanooga, Tennessee.
FAU - McConnell, Jeffrey R
AU  - McConnell JR
AD  - Orthopedic Associates of Allentown, Allentown, Pennsylvania.
FAU - Dryer, Randall F
AU  - Dryer RF
AD  - Central Texas Spine Institute, Austin, Texas.
FAU - Schranck, Francine W
AU  - Schranck FW
AD  - SPIRITT Research, St Louis, Missouri.
FAU - Copay, Anne G
AU  - Copay AG
AD  - SPIRITT Research, St Louis, Missouri.
LA  - eng
SI  - ClinicalTrials.gov/NCT00667459
SI  - ClinicalTrials.gov/NCT00642876
SI  - ClinicalTrials.gov/NCT00637156
PT  - Journal Article
DEP - 20191231
PL  - Netherlands
TA  - Int J Spine Surg
JT  - International journal of spine surgery
JID - 101579005
PMC - PMC6962002
OTO - NOTNLM
OT  - anterior cervical discectomy and fusion (ACDF)
OT  - cervical disc arthroplasty (CDA)
OT  - cervical disc disease
COIS- Disclosures and COI: The institutional review board for the clinical trials was 
      Western Institutional Review Board (1-level study: Protocol 20050083, Study 
      1064723; 2-level study: Protocol 20060636, Study 1078218).The authors report the 
      following potential or perceived conflicts: MF Gornet: Consulting: Aesculap and 
      Medtronic; Stock Ownership: Bonovo, International Spine & Orthopedic Institute, 
      LLC, Nocimed, OuroBoros, Paradigm Spine; Royalties: Medtronic and RTI. TH Lanman: 
      Consulting: Medtronic, Nuvasive, Stryker; Royalites: Stryker, Medtronic. J.K. 
      Burkus: Consulting: Medtronic and Zimmer-Biomet; Royalties: Zimmer-Biomet; 
      Research Support: Medtronic and Nuvasive. SD Hodges: Consulting: Medtronic. JR 
      McConnell: Consulting: Globus Medical, DePuy/Synthes, IMSE; Royalties: Globus 
      Medical; Stock Ownership: Globus Medical; Speakers Bureau: Globus Medical, 
      Zimmerman Biomet. RG Dryer: Consulting: Royalties: Nuvasive and Globus Medical. 
      FW Schranck: Stock Ownership: Nocimed. AG Copay: None to declare.
EDAT- 2020/01/24 06:00
MHDA- 2020/01/24 06:01
PMCR- 2019/12/31
CRDT- 2020/01/24 06:00
PHST- 2020/01/24 06:00 [entrez]
PHST- 2020/01/24 06:00 [pubmed]
PHST- 2020/01/24 06:01 [medline]
PHST- 2019/12/31 00:00 [pmc-release]
AID - 10.14444/6076 [doi]
PST - epublish
SO  - Int J Spine Surg. 2019 Dec 31;13(6):551-560. doi: 10.14444/6076. eCollection 2019 
      Dec.