Dr. McConnell’s Research Published in the Journal of Neurosurgery

May 15, 2017

Dr. Jeffrey McConnell of OAA’s Spine Center of Excellence is not only committed to providing superior spinal care to his patients, but he is also very active in clinical and professional research. Dr. McConnell has presented his research in the United States and internationally at scientific meetings including the European Spine Society, International Society for the Study of the Lumbar Spine, NASS, AANS, and the International Society for the Advancement of Spine Surgery.
 
Most recently, Dr. McConnell’s long-term involvement with a clinical trial focused on the Prestige LP artificial cervical disc replacement at two levels, was published in the Journal of Neurosurgery. Below is the article as it was published:
 
Long-term clinical and radiographic outcomes of the Prestige LP artificial cervical disc replacement at 2 levels: results from a prospective randomized controlled clinical trial

Todd H. Lanman, MD1, J. Kenneth Burkus, MD2, Randall G. Dryer, MD3, Matthew F. Gornet, MD4, Jeffrey McConnell, MD5, and Scott D. Hodges, DO6

1Institute for Spinal Disorders, Cedars-Sinai Medical Center, Los Angeles, California; 2Wilderness Spine Services, Columbus, Georgia; 3Central Texas Spine Institute, Austin, Texas; 4The Orthopedic Center of St. Louis, Missouri; 5OAA Orthopedic Specialists, Allentown, Pennsylvania; and 6Center for Sports Medicine & Orthopaedics, Chattanooga, Tennessee

ABBREVIATIONS ACDF = anterior cervical discectomy and fusion; ADR = artificial disc replacement; AE = adverse event; BCI = Bayesian credible interval; DDD = degenerative disc disease; FSU = functional spinal unit; HO = heterotopic ossification; LHR = log hazard ratio; MCS = Mental Component Summary; NDI = Neck Disability Index; PCS = Physical Component Summary; PPS = posterior probability of superiority; TDR = total disc replacement.

INCLUDE WHEN CITING Published online April 7, 2017; DOI: 10.3171/2016.11.SPINE16746.

Related Articles
By Keywords:
cervical degenerative disc diseasecervical disc arthroplastyPrestige LP disc replacementartificial cervical disc2-level disc disease

Abstract
OBJECTIVE
The aim of this study was to assess long-term clinical safety and effectiveness in patients undergoing anterior cervical surgery using the Prestige LP artificial disc replacement (ADR) prosthesis to treat degenerative cervical spine disease at 2 adjacent levels compared with anterior cervical discectomy and fusion (ACDF).

METHODS
A prospective, randomized, controlled, multicenter FDA-approved clinical trial was conducted at 30 US centers, comparing the low-profile titanium ceramic composite-based Prestige LP ADR (n = 209) at 2 levels with ACDF (n = 188). Clinical and radiographic evaluations were completed preoperatively, intraoperatively, and at regular postoperative intervals to 84 months. The primary end point was overall success, a composite variable that included key safety and efficacy considerations.

RESULTS
At 84 months, the Prestige LP ADR demonstrated statistical superiority over fusion for overall success (observed rate 78.6% vs 62.7%; posterior probability of superiority [PPS] = 99.8%), Neck Disability Index success (87.0% vs 75.6%; PPS = 99.3%), and neurological success (91.6% vs 82.1%; PPS = 99.0%). All other study effectiveness measures were at least noninferior for ADR compared with ACDF. There was no statistically significant difference in the overall rate of implant-related or implant/surgical procedure–related adverse events up to 84 months (26.6% and 27.7%, respectively). However, the Prestige LP group had fewer serious (Grade 3 or 4) implant- or implant/surgical procedure–related adverse events (3.2% vs 7.2%, log hazard ratio [LHR] and 95% Bayesian credible interval [95% BCI] −1.19 [−2.29 to −0.15]). Patients in the Prestige LP group also underwent statistically significantly fewer second surgical procedures at the index levels (4.2%) than the fusion group (14.7%) (LHR −1.29 [95% BCI −2.12 to −0.46]). Angular range of motion at superior- and inferior-treated levels on average was maintained in the Prestige LP ADR group to 84 months.

CONCLUSIONS
The low-profile artificial cervical disc in this study, Prestige LP, implanted at 2 adjacent levels, maintains improved clinical outcomes and segmental motion 84 months after surgery and is a safe and effective alternative to fusion.

Clinical trial registration no.: NCT00637156 (clinicaltrials.gov)
Journal of Neurosurgery
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