title: 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.
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).
authors.affiliation: Institute for Spinal Disorders, Cedars-Sinai Medical Center, Los Angeles, California.
authors.forename: Todd H
authors.initials: TH
authors.lastname: Lanman
authors.affiliation: Wilderness Spine Services, Columbus, Georgia.
authors.forename: J Kenneth
authors.initials: JK
authors.lastname: Burkus
authors.affiliation: Central Texas Spine Institute, Austin, Texas.
authors.forename: Randall G
authors.initials: RG
authors.lastname: Dryer
authors.affiliation: The Orthopedic Center of St. Louis, Missouri.
authors.forename: Matthew F
authors.initials: MF
authors.lastname: Gornet
authors.affiliation: Orthopedic Specialists, Allentown, Pennsylvania; and.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: McConnell
authors.affiliation: Center for Sports Medicine & Orthopaedics, Chattanooga, Tennessee.
authors.forename: Scott D
authors.initials: SD
authors.lastname: Hodges
mesh_terms: D000328:Adult; D000368:Aged; D002516:Ceramics; D002574:Cervical Vertebrae / Q000000981:diagnostic imaging* / Q000601:surgery*; D004185:Disability Evaluation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D011183:Postoperative Complications; D019736:Prostheses and Implants; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012086:Reoperation; D013123:Spinal Fusion; D014025:Titanium; D059145:Total Disc Replacement / Q000295:instrumentation*; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
chemical_list: D014025:Titanium
keywords: 2-level disc disease; 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; Prestige LP disc replacement; TDR = total disc replacement; artificial cervical disc; cervical degenerative disc disease; cervical disc arthroplasty