PMID- 25694918
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20150219
LR  - 20220408
IS  - 2211-4599 (Print)
IS  - 2211-4599 (Electronic)
IS  - 2211-4599 (Linking)
VI  - 8
DP  - 2014
TI  - Multi-center, prospective, randomized, controlled investigational device 
      exemption clinical trial comparing Mobi-C Cervical Artificial Disc to anterior 
      discectomy and fusion in the treatment of symptomatic degenerative disc disease 
      in the cervical spine.
LID - 10.14444/1007 [doi]
LID - 7
AB  - BACKGROUND: Anterior cervical discectomy and fusion (ACDF) is the gold standard 
      for treating symptomatic cervical disc degeneration. Cervical total disc 
      replacements (TDRs) have emerged as an alternative for some patients. The purpose 
      of this study was to evaluate the safety and effectiveness of a new TDR device 
      compared with ACDF for treating single-level cervical disc degeneration. METHODS: 
      This was a prospective, randomized, controlled, multicenter Food and Drug 
      Administration (FDA) regulated Investigational Device Exemption (IDE) study. A 
      total of 245 patients were treated (164 TDR: 81 ACDF). The primary outcome 
      measure was overall success based on improvement in Neck Disability Index (NDI), 
      no subsequent surgical interventions, and no adverse events (AEs) classified as 
      major complications. Secondary outcome measures included SF-12, visual analog 
      scale (VAS) assessing neck and arm pain, patient satisfaction, radiographic range 
      of motion, and adjacent level degeneration. Patients were evaluated 
      preoperatively and postoperatively at 6 weeks, 3, 6, 12, 18, and 24 months. The 
      hypothesis was that the TDR success rate was non-inferior to ACDF at 24 months. 
      RESULTS: Overall success rates were 73.6% for TDR and 65.3% for ACDF, confirming 
      non-inferiority (p < 0.0025). TDR demonstrated earlier improvements with 
      significant differences in NDI scores at 6 weeks and 3 months, and VAS neck pain 
      and SF-12 PCS scores at 6 weeks (p<0.05). Operative level range of motion in the 
      TDR group was maintained throughout follow-up. Radiographic evidence of inferior 
      adjacent segment degeneration was significantly greater with ACDF at 12 and 24 
      months (p < 0.05). AE rates were similar. CONCLUSIONS: Mobi-C TDR is a safe and 
      effective treatment for single-level disc degeneration, producing outcomes 
      similar to ACDF with less adjacent segment degeneration. LEVEL OF EVIDENCE: Level 
      I. CLINICAL RELEVANCE: This study adds to the literature supporting cervical TDR 
      as a viable option to ACDF in appropriately selected patients with disc 
      degeneration.
FAU - Hisey, Michael S
AU  - Hisey MS
AD  - Texas Back Institute, Denton, TX.
FAU - Bae, Hyun W
AU  - Bae HW
AD  - The Spine Institute at St. John's Health Center, Santa Monica, CA.
FAU - Davis, Reginald
AU  - Davis R
AD  - GBMC Healthcare Greater Baltimore Neurosurgical Associates, Baltimore MD.
FAU - Gaede, Steven
AU  - Gaede S
AD  - Oklahoma Spine & Brain Institute, Tulsa, OK.
FAU - Hoffman, Greg
AU  - Hoffman G
AD  - Orthopedic North East, Fort Wayne, IN.
FAU - Kim, Kee
AU  - Kim K
AD  - University of California Davis Medical Center, Sacramento, CA.
FAU - Nunley, Pierce D
AU  - Nunley PD
AD  - Spine Institute of Louisiana, Shreveport, LA.
FAU - Peterson, Daniel
AU  - Peterson D
AD  - Neurological Specialists of Austin, Austin, TX.
FAU - Rashbaum, Ralph
AU  - Rashbaum R
AD  - Texas Back Institute, Plano, TX.
FAU - Stokes, John
AU  - Stokes J
AD  - Neurological Specialists of Austin, Austin, TX.
LA  - eng
PT  - Journal Article
DEP - 20141201
PL  - Netherlands
TA  - Int J Spine Surg
JT  - International journal of spine surgery
JID - 101579005
PMC - PMC4325486
OTO - NOTNLM
OT  - Cervical Spine
OT  - anterior cervical fusion
OT  - clinical outcome
OT  - randomized study
OT  - total disc replacement
EDAT- 2015/02/20 06:00
MHDA- 2015/02/20 06:01
PMCR- 2014/12/01
CRDT- 2015/02/20 06:00
PHST- 2015/02/20 06:00 [entrez]
PHST- 2015/02/20 06:00 [pubmed]
PHST- 2015/02/20 06:01 [medline]
PHST- 2014/12/01 00:00 [pmc-release]
AID - 14444-1007 [pii]
AID - 10.14444/1007 [doi]
PST - epublish
SO  - Int J Spine Surg. 2014 Dec 1;8:7. doi: 10.14444/1007. eCollection 2014.