Authors: Todd Hopkins Lanman, MD, FAANS; Matthew Gornet, MD; Randall Dryer, MD; J. Kenneth Burkus, MD; Scott Hodges, MD; Jeffrey McConnell, MD (Beverly Hills, CA)
Introduction: This paper reports the 10-year results of the Prestige LP FDA trial (clinicaltrials.gov: NCT00637156) comparing the safety and efficacy of Cervical Disc Arthroplasty and ACDF attwo contiguous levels. Methods: 397 patients with two-level radiculopathy and/or myelopathy between C3 and C7 were randomized and treated with investigational CDA (n=209) or control ACDF (n=188). The primary endpoint was Overall Success, a composite variable that included 4 criteria:1) Neck Disability Index (NDI) improvement of ≥ 15 points, 2) maintenance/improvement in neurological status, 3) no serious adverse events, and 4) no additional surgery. Results: Patient follow-up at 10 years was 86.0% for investigational and 84.9% for control patients. At 10 years postoperative, the rates of Overall Success,NDI Success and Neurological Success rates demonstrated statistical superiority for CDA over ACDF. At all postoperative time points, NDI, neck and arm pain, and SF-36 score improvements were statistically significant in both groups. NDI and neck pain score improvements achieved statistical superiority for CDA over ACDF at all time points from 2 to 10 years. Rates of serious AEs, serious AEs related to implant/procedure, and secondary surgeries at the index and adjacent levels were statistically lower for CDA than ACDF. The 10-year angular range of motion at the index levels increased by more than 2 degrees in 43.8%, was maintained within 2 degrees in 17.7%, and decreased by more than 2 degrees in 38.5% of CDA patients. The 10-year rates of heterotopic ossification were 20.5% and 19.9% for Grade III and 8.2% and 10.3% for Grade IV at the superior and inferior levels, respectively. Conclusion: In appropriately selected patients, CDA with the Prestige LP Disc is at least as safe and effective as ACDF for symptomatic cervical DDD at 2 contiguous levels.