PMID- 31100723
OWN - NLM
STAT- MEDLINE
DCOM- 20200324
LR  - 20200324
IS  - 1547-5646 (Electronic)
IS  - 1547-5646 (Linking)
VI  - 31
IP  - 3
DP  - 2019 May 17
TI  - Lumbar disc arthroplasty versus anterior lumbar interbody fusion: 5-year outcomes 
      for patients in the Maverick disc investigational device exemption study.
PG  - 347-356
LID - 2019.2.SPINE181037 [pii]
LID - 10.3171/2019.2.SPINE181037 [doi]
AB  - OBJECTIVE: Despite evidence of its safety and effectiveness, the use of lumbar 
      disc arthroplasty has been slow to expand due in part to concerns about late 
      complications and the risks of revision surgery associated with early devices. 
      More recently, FDA approval of newer devices and improving reimbursements have 
      reversed this trend in the United States. Additional long-term data on lumbar 
      disc arthroplasty are still needed. This study reports the 5-year results of the 
      FDA investigational device exemption clinical trial of the Medtronic Spinal and 
      Biologics' Maverick total disc replacement. METHODS: Patients with single-level 
      degenerative disc disease from L4 to S1 were randomized 2:1 at 31 investigational 
      sites. In the period from April 2003 to August 2004, 405 patients received the 
      investigational device and 172 patients underwent the control procedure of 
      anterior lumbar interbody fusion. Outcome measures included the Oswestry 
      Disability Index (ODI), numeric rating scales (NRSs) for back and leg pain, the 
      SF-36, disc height, interbody motion, heterotopic ossification (investigational 
      device), adverse events (AEs), additional surgeries, and neurological status. 
      Treatment was considered an overall success when all of the following criteria 
      were met: 1) ODI score improvement >/= 15 points over the preoperative score; 2) 
      maintenance or improvement in neurological status compared with preoperatively; 
      3) disc height success, that is, no more than a 2-mm reduction in anterior or 
      posterior height; 4) no serious AEs caused by the implant or by the implant and 
      the surgical procedure; and 5) no additional surgery classified as a failure. 
      RESULTS: Compared to that in the control group, improvement in the 
      investigational group was statistically greater according to the ODI and SF-36 
      Physical Component Summary (PCS) at 1, 2, and 5 years; the NRS for back pain at 1 
      and 2 years; and the NRS for leg pain at 1 year. The rates of heterotopic 
      ossification increased over time: 1.0% (4/382) at 1 year, 2.6% (9/345) at 2 
      years, and 5.9% (11/187) at 5 years. Investigational patients had fewer 
      device-related AEs and serious device-related AEs than the control patients at 
      both 2 and 5 years postoperatively. Noninferiority of the composite measure 
      overall success was demonstrated at all follow-up intervals; superiority was 
      demonstrated at 1 and 2 years. CONCLUSIONS: Lumbar disc arthroplasty is a safe 
      and effective treatment for single-level lumbar degenerative disc disease, 
      resulting in improved physical function and reduced pain up to 5 years after 
      surgery.Clinical trial registration no.: NCT00635843 (clinicaltrials.gov).
FAU - Gornet, Matthew F
AU  - Gornet MF
AD  - 1The Orthopedic Center of St. Louis, St. Louis, Missouri.
FAU - Burkus, J Kenneth
AU  - Burkus JK
AD  - 2Wilderness Spine Services, Columbus, Georgia.
FAU - Dryer, Randall F
AU  - Dryer RF
AD  - 3Central Texas Spine Institute, Austin, Texas.
FAU - Peloza, John H
AU  - Peloza JH
AD  - 4Center for Spine Care, Dallas, Texas; and.
FAU - Schranck, Francine W
AU  - Schranck FW
AD  - 5SPIRITT Research, St. Louis, Missouri.
FAU - Copay, Anne G
AU  - Copay AG
AD  - 5SPIRITT Research, St. Louis, Missouri.
LA  - eng
SI  - ClinicalTrials.gov/NCT00635843
PT  - Journal Article
PL  - United States
TA  - J Neurosurg Spine
JT  - Journal of neurosurgery. Spine
JID - 101223545
SB  - IM
MH  - Cervical Vertebrae/surgery
MH  - Diskectomy/methods
MH  - Follow-Up Studies
MH  - Humans
MH  - Intervertebral Disc/*surgery
MH  - Intervertebral Disc Degeneration/*surgery
MH  - Lumbar Vertebrae/*surgery
MH  - Lumbosacral Region/*surgery
MH  - Pain Measurement
MH  - Spinal Fusion/methods
MH  - Total Disc Replacement/methods
OTO - NOTNLM
OT  - AE = adverse event
OT  - ALIF = anterior lumbar interbody fusion
OT  - DDD = degenerative disc disease
OT  - HO = heterotopic ossification
OT  - IDE = investigational device exemption
OT  - MCS = Mental Component Summary
OT  - NRS = numeric rating scale
OT  - ODI = Oswestry Disability Index
OT  - PCS = Physical Component Summary
OT  - degenerative disc disease
OT  - heterotopic ossification
OT  - lumbar disc arthroplasty
OT  - total disc replacement
EDAT- 2019/05/18 06:00
MHDA- 2020/03/25 06:00
CRDT- 2019/05/18 06:00
PHST- 2018/08/23 00:00 [received]
PHST- 2019/02/12 00:00 [accepted]
PHST- 2019/05/18 06:00 [pubmed]
PHST- 2020/03/25 06:00 [medline]
PHST- 2019/05/18 06:00 [entrez]
AID - 2019.2.SPINE181037 [pii]
AID - 10.3171/2019.2.SPINE181037 [doi]
PST - ppublish
SO  - J Neurosurg Spine. 2019 May 17;31(3):347-356. doi: 10.3171/2019.2.SPINE181037.