PMID- 26230424 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220408 IS - 1547-5646 (Electronic) IS - 1547-5646 (Linking) VI - 23 IP - 5 DP - 2015 Nov TI - Cervical disc arthroplasty with PRESTIGE LP disc versus anterior cervical discectomy and fusion: a prospective, multicenter investigational device exemption study. PG - 558-573 LID - 10.3171/2015.1.SPINE14589 [doi] AB - OBJECT This study compared the safety and efficacy of treatment with the PRESTIGE LP cervical disc versus a historical control anterior cervical discectomy and fusion (ACDF). METHODS Prospectively collected PRESTIGE LP data from 20 investigational sites were compared with data from 265 historical control ACDF patients in the initial PRESTIGE Cervical Disc IDE study. The 280 investigational patients with single-level cervical disc disease with radiculopathy and/or myelopathy underwent arthroplasty with a low-profile artificial disc. Key safety/efficacy outcomes included Neck Disability Index (NDI), Neck and Arm Pain Numerical Rating Scale scores, 36-Item Short Form Health Survey (SF-36) score, work status, disc height, range of motion, adverse events (AEs), additional surgeries, and neurological status. Clinical and radiographic evaluations were completed preoperatively, intraoperatively, and at 1.5, 3, 6, 12, and 24 months postoperatively. Predefined Bayesian statistical methods with noninformative priors were used, along with the propensity score technique for controlling confounding factors. Analysis by independent statisticians confirmed initial statistical findings. RESULTS The investigational and control groups were mostly similar demographically. There was no significant difference in blood loss (51.0 ml [investigational] vs 57.1 ml [control]) or hospital stay (0.98 days [investigational] vs 0.95 days [control]). The investigational group had a significantly longer operative time (1.49 hours vs 1.38 hours); 95% Bayesian credible interval of the difference was 0.01-0.21 hours. Significant improvements versus preoperative in NDI, neck/arm pain, SF-36, and neurological status were achieved by 1.5 months in both groups and were sustained at 24 months. Patient follow-up at 24 months was 97.1% for the investigational group and 84.0% for the control group. The mean NDI score improvements versus preoperative exceeded 30 points in both groups at 12 and 24 months. SF-36 Mental Component Summary superiority was established (Bayesian probability 0.993). The mean SF-36 PCS scores improved by 14.3 points in the investigational group and by 11.9 points in the control group from baseline to 24 months postoperatively. Neurological success at 24 months was 93.5% in the investigational group and 83.5% in the control group (probability of superiority ~ 1.00). At 24 months, 12.1% of investigational and 15.5% of control patients had an AE classified as device or device/surgical procedure related; 14 (5.0%) investigational and 21 (7.9%) control patients had a second surgery at the index level. The median return-to-work time for the investigational group was 40 days compared with 60 days for the control group (p = 0.020 after adjusting for preoperative work status and propensity score). Following implantation of the PRESTIGE LP device, the mean angular motion was maintained at 12 months (7.9 degrees ) and 24 months (7.5 degrees ). At 24 months, 90.0% of investigational and 87.7% of control patients were satisfied with the results of surgery. PRESTIGE LP superiority on overall success (without disc height success), a composite safety/efficacy end point, was strongly supported with 0.994 Bayesian probability. CONCLUSIONS This device maintains mean postoperative segmental motion while providing the potential for biomechanical stability. Investigational patients reported significantly improved clinical outcomes compared with baseline, at least noninferior to ACDF, up to 24 months after surgery. FAU - Gornet, Matthew F AU - Gornet MF AD - The Orthopedic Center of St. Louis, Missouri. FAU - Burkus, J Kenneth AU - Burkus JK AD - Wilderness Spine Services, The Hughston Clinic, Columbus, Georgia. FAU - Shaffrey, Mark E AU - Shaffrey ME AD - Department of Neurosurgery, University of Virginia Health System, Charlottesville, Virginia. FAU - Argires, Perry J AU - Argires PJ AD - Brain Orthopedic Spine Specialists, Lancaster, Pennsylvania; and. 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 PT - Journal Article DEP - 20150731 PL - United States TA - J Neurosurg Spine JT - Journal of neurosurgery. Spine JID - 101223545 OTO - NOTNLM OT - ACDF = anterior cervical discectomy and fusion OT - AE = adverse event OT - ASD = adjacent-segment disease OT - CDA = cervical disc arthroplasty OT - DDD = degenerative disc disease OT - FSU = functional spinal unit OT - HPD = highest posterior density OT - IDE = investigational device exemption OT - MCS = Mental Component Summary OT - NDI = Neck Disability Index OT - PCS = Physical Component Summary OT - SF-36 = 36-Item Short Form Health Survey OT - adjacent level disease OT - anterior cervical discectomy and fusion OT - artificial cervical disc OT - cervical disc arthroplasty OT - cervical myelopathy OT - cervical radiculopathy EDAT- 2015/08/01 06:00 MHDA- 2015/08/01 06:01 CRDT- 2015/08/01 06:00 PHST- 2015/08/01 06:00 [pubmed] PHST- 2015/08/01 06:01 [medline] PHST- 2015/08/01 06:00 [entrez] AID - 10.3171/2015.1.SPINE14589 [doi] PST - ppublish SO - J Neurosurg Spine. 2015 Nov;23(5):558-573. doi: 10.3171/2015.1.SPINE14589. Epub 2015 Jul 31.