PMID- 28304237 OWN - NLM STAT- MEDLINE DCOM- 20170626 LR - 20220408 IS - 1547-5646 (Electronic) IS - 1547-5646 (Linking) VI - 26 IP - 6 DP - 2017 Jun TI - Cervical disc arthroplasty with the Prestige LP disc versus anterior cervical discectomy and fusion, at 2 levels: results of a prospective, multicenter randomized controlled clinical trial at 24 months. PG - 653-667 LID - 10.3171/2016.10.SPINE16264 [doi] AB - OBJECTIVE The authors compared the efficacy and safety of arthroplasty using the Prestige LP cervical disc with those of anterior cervical discectomy and fusion (ACDF) for the treatment of degenerative disc disease (DDD) at 2 adjacent levels. METHODS Patients from 30 investigational sites were randomized to 1 of 2 groups: investigational patients (209) underwent arthroplasty using a Prestige LP artificial disc, and control patients (188) underwent ACDF with a cortical ring allograft and anterior cervical plate. Patients were evaluated preoperatively, intraoperatively, and at 1.5, 3, 6, 12, and 24 months postoperatively. Efficacy and safety outcomes were measured according to the Neck Disability Index (NDI), Numeric Rating Scales for neck and arm pain, 36-Item Short-Form Health Survey (SF-36), gait abnormality, disc height, range of motion (investigational) or fusion (control), adverse events (AEs), additional surgeries, and neurological status. Treatment was considered an overall success when all 4 of the following criteria were met: 1) NDI score improvement of >/= 15 points over the preoperative score, 2) maintenance or improvement in neurological status compared with preoperatively, 3) no serious AE caused by the implant or by the implant and surgical procedure, and 4) no additional surgery (supplemental fixation, revision, or nonelective implant removal). Independent statisticians performed Bayesian statistical analyses. RESULTS The 24-month rates of overall success were 81.4% for the investigational group and 69.4% for the control group. The posterior mean for overall success in the investigational group exceeded that in the control group by 0.112 (95% highest posterior density interval = 0.023 to 0.201) with a posterior probability of 1 for noninferiority and 0.993 for superiority, demonstrating the superiority of the investigational group for overall success. Noninferiority of the investigational group was demonstrated for all individual components of overall success and individual effectiveness end points, except for the SF-36 Mental Component Summary. The investigational group was superior to the control group for NDI success. The proportion of patients experiencing any AE was 93.3% (195/209) in the investigational group and 92.0% (173/188) in the control group, which were not statistically different. The rate of patients who reported any serious AE (Grade 3 or 4) was significantly higher in the control group (90 [47.9%] of 188) than in the investigational group (72 [34.4%] of 209) with a posterior probability of superiority of 0.996. Radiographic success was achieved in 51.0% (100/196) of the investigational patients (maintenance of motion without evidence of bridging bone) and 82.1% (119/145) of the control patients (fusion). At 24 months, heterotopic ossification was identified in 27.8% (55/198) of the superior levels and 36.4% (72/198) of the inferior levels of investigational patients. CONCLUSIONS Arthroplasty with the Prestige LP cervical disc is as effective and safe as ACDF for the treatment of cervical DDD at 2 contiguous levels and is an alternative treatment for intractable radiculopathy or myelopathy at 2 adjacent levels. Clinical trial registration no.: NCT00637156 ( clinicaltrials.gov ). FAU - Gornet, Matthew F AU - Gornet MF AD - The Orthopedic Center of St. Louis. 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, The Hughston Clinic, Columbus, Georgia. FAU - Hodges, Scott D AU - Hodges SD AD - Center for Sports Medicine and Orthopaedics, Chattanooga. FAU - McConnell, Jeffrey R AU - McConnell JR AD - Orthopaedic Associates of Allentown, Pennsylvania; and. FAU - Dryer, Randall F AU - Dryer RF AD - Central Texas Spine Institute, Austin, Texas. FAU - Copay, Anne G AU - Copay AG AD - SPIRITT Research, St. Louis, Missouri. FAU - Nian, Hui AU - Nian H AD - Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, Tennessee. FAU - Harrell, Frank E Jr AU - Harrell FE Jr AD - Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, Tennessee. LA - eng SI - ClinicalTrials.gov/NCT00637156 PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20170317 PL - United States TA - J Neurosurg Spine JT - Journal of neurosurgery. Spine JID - 101223545 SB - IM MH - Allografts MH - Bone Plates MH - Bone Transplantation MH - Cervical Vertebrae/*surgery MH - *Diskectomy MH - Female MH - Humans MH - Intervertebral Disc Degeneration/*surgery MH - Male MH - Middle Aged MH - Patient Satisfaction MH - Postoperative Complications MH - *Prostheses and Implants MH - Return to Work MH - Severity of Illness Index MH - *Spinal Fusion MH - Time Factors MH - *Total Disc Replacement MH - Treatment Outcome OTO - NOTNLM OT - ACDF = anterior cervical discectomy and fusion OT - AE = adverse event OT - ASD = adjacent segment degeneration OT - CAC = Clinical Adjudication Committee OT - CDA = cervical disc arthroplasty OT - DDD = degenerative disc disease OT - FDA = Food and Drug Administration OT - FSU = functional spinal unit OT - HO = heterotopic ossification OT - HPD = highest posterior density OT - IDE = investigational device exemption OT - MCS = Mental Component Summary OT - NDI = Neck Disability Index OT - NRS = Numeric Rating Scale OT - PCS = Physical Component Summary OT - SF-36 = 36-Item Short-Form Health Survey OT - adjacent segment disease OT - anterior cervical discectomy and fusion OT - artificial cervical disc OT - cervical disc arthroplasty EDAT- 2017/03/18 06:00 MHDA- 2017/06/27 06:00 CRDT- 2017/03/18 06:00 PHST- 2017/03/18 06:00 [pubmed] PHST- 2017/06/27 06:00 [medline] PHST- 2017/03/18 06:00 [entrez] AID - 10.3171/2016.10.SPINE16264 [doi] PST - ppublish SO - J Neurosurg Spine. 2017 Jun;26(6):653-667. doi: 10.3171/2016.10.SPINE16264. Epub 2017 Mar 17.