PMID- 32168483
OWN - NLM
STAT- Publisher
LR  - 20240227
IS  - 1547-5646 (Electronic)
IS  - 1547-5646 (Linking)
DP  - 2020 Mar 13
TI  - Occurrence and clinical implications of heterotopic ossification after cervical 
      disc arthroplasty with the Prestige LP Cervical Disc at 2 contiguous levels.
PG  - 1-10
LID - 2020.1.SPINE19816 [pii]
LID - 10.3171/2020.1.SPINE19816 [doi]
AB  - OBJECTIVE: The authors sought to assess the impact of heterotopic ossification 
      (HO) on clinical outcomes and angular range of motion (ROM) after cervical disc 
      arthroplasty (CDA) performed with the Prestige LP Cervical Disc (Prestige LP 
      disc) at 2 levels. METHODS: HO was assessed and graded from 0 to IV for 
      increasing severity on lateral neutral radiographs at each visit in 209 patients 
      who underwent implantation of Prestige LP discs at 2 cervical levels in a 
      clinical trial with extended 10-year follow-up. ROM was compared by using HO 
      grade, and clinical outcomes were compared between HO subgroups (grade 0-II vs 
      III/IV) based on HO severity at 2 and 10 years after surgery. RESULTS: The grade 
      III/IV HO incidence at either or both index levels was 24.2% (48/198) at 2 years 
      and 39.0% (57/146) at 10 years. No statistical difference was found in overall 
      success; neurological success; or Neck Disability Index (NDI), neck pain, arm 
      pain, or SF-36 Physical Component Summary (PCS) scores between the HO subgroups 
      (grade 0-II vs III/IV) at either 2 or 10 years. The cumulative rate of possible 
      implant-related adverse events (AEs) was higher in patients having grade III/IV 
      HO at 2 years (56.3%) and 10 years (47.8%) compared with those having grade 0-II 
      HO at 2 years (24.4%) and 10 years (17.9%), specifically in 2 subcategories: 
      spinal events and HOs reported by the investigators. No statistical difference 
      was found between the HO subgroups in possible implant-related serious AEs or 
      secondary surgeries at the index or adjacent levels. The average angular ROMs at 
      index levels were lower in subjects with higher-grade HO at 2 and 10 years. The 
      average ROMs at the superior level were 8.8 degrees , 6.6 degrees , 3.2 degrees , and 0.3 degrees , respectively, 
      for the HO grade 0/I, II, III, and IV groups at 10 years, and 7.9 degrees , 6.2 degrees , 3.7 degrees , 
      and 0.6 degrees , respectively, at the inferior level. CONCLUSIONS: Radiographically 
      severe (grade III or IV) HO after CDA with the Prestige LP disc at 2 levels did 
      not significantly affect efficacy or safety outcomes (severe AEs or secondary 
      surgeries). However, severe HO, particularly grade IV HO, significantly limited 
      ROM, as expected.
FAU - Gornet, Matthew F
AU  - Gornet MF
AD  - 1The Orthopedic Center of St. Louis, Missouri.
FAU - Lanman, Todd H
AU  - Lanman TH
AD  - 2Institute for Spinal Disorders, Cedars-Sinai Medical Center, Los Angeles, 
      California.
FAU - Burkus, J Kenneth
AU  - Burkus JK
AD  - 3Wilderness Spine Services, Columbus, Georgia.
FAU - Dryer, Randall F
AU  - Dryer RF
AD  - 4Central Texas Spine Institute, Austin, Texas.
FAU - McConnell, Jeffrey R
AU  - McConnell JR
AD  - 5Orthopedic Specialists, Allentown, Pennsylvania.
FAU - Hodges, Scott D
AU  - Hodges SD
AD  - 6Center for Sports Medicine & Orthopaedics, Chattanooga, Tennessee.
FAU - Schranck, Francine W
AU  - Schranck FW
AD  - 7SPIRITT Research, St. Louis, Missouri; and.
FAU - Ma, Guorong
AU  - Ma G
AD  - 8Medtronic, Memphis, Tennessee.
LA  - eng
PT  - Journal Article
DEP - 20200313
PL  - United States
TA  - J Neurosurg Spine
JT  - Journal of neurosurgery. Spine
JID - 101223545
SB  - IM
OTO - NOTNLM
OT  - ACDF = anterior cervical discectomy and fusion
OT  - AE = adverse event
OT  - CDA = cervical disc arthroplasty
OT  - HO
OT  - HO = heterotopic ossification
OT  - NDI = Neck Disability Index
OT  - PAS = postapproval study
OT  - Prestige LP Cervical Disc
OT  - Prestige LP disc = Prestige LP Cervical Disc
OT  - ROM = range of motion
OT  - SAE = serious AE
OT  - VAS = visual analog scale
OT  - cervical disc arthroplasty
OT  - heterotopic ossification
EDAT- 2020/03/14 06:00
MHDA- 2020/03/14 06:00
CRDT- 2020/03/14 06:00
PHST- 2019/07/11 00:00 [received]
PHST- 2020/01/07 00:00 [accepted]
PHST- 2020/03/14 06:00 [pubmed]
PHST- 2020/03/14 06:00 [medline]
PHST- 2020/03/14 06:00 [entrez]
AID - 2020.1.SPINE19816 [pii]
AID - 10.3171/2020.1.SPINE19816 [doi]
PST - aheadofprint
SO  - J Neurosurg Spine. 2020 Mar 13:1-10. doi: 10.3171/2020.1.SPINE19816.