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.

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)

Two-level cervical disc arthroplasty versus anterior cervical discectomy and fusion: 10-year outcomes of a prospective, randomized investigational device exemption clinical trial.

OBJECTIVE: The authors assessed the 10-year clinical safety and effectiveness of cervical disc arthroplasty (CDA) to treat degenerative cervical spine disease at 2 adjacent levels compared to anterior cervical discectomy and fusion (ACDF). METHODS: A prospective, randomized, controlled, multicenter FDA-approved clinical trial was conducted comparing the low-profile titanium ceramic composite-based Prestige LP Cervical Disc (n = 209) at two levels with ACDF (n = 188). Ten-year follow-up data from a postapproval study were available on 148 CDA and 118 ACDF patients and are reported here. Clinical and radiographic evaluations were completed preoperatively, intraoperatively, and at regular postoperative follow-up intervals for up to 10 years. The primary endpoint was overall success, a composite variable that included key safety and efficacy considerations. Ten-year follow-up rates were 86.0% for CDA and 84.9% for ACDF. RESULTS: From 2 to 10 years, CDA demonstrated statistical superiority over ACDF for overall success, with rates at 10 years of 80.4% versus 62.2%, respectively (posterior probability of superiority [PPS] = 99.9%). Neck Disability Index (NDI) success was also superior, with rates at 10 years of 88.4% versus 76.5% (PPS = 99.5%), as was neurological success (92.6% vs 86.1%; PPS = 95.6%). Improvements from preoperative results in NDI and neck pain scores were consistently statistically superior for CDA compared to ACDF. All other study effectiveness measures were at least noninferior for CDA compared to ACDF through the 10-year follow-up period, including disc height. Mean angular ranges of motion at treated levels were maintained in the CDA group for up to 10 years. The rates of grade IV heterotopic ossification (HO) at the superior and inferior levels were 8.2% and 10.3%, respectively. The rate of severe HO (grade III or IV) did not increase significantly from 7 years (42.4%) to 10 years (39.0%). The CDA group had fewer serious (grade 3-4) implant-related or implant/surgical procedure-related adverse events (3.8% vs 8.1%; posterior mean 95% Bayesian credible interval [BCI] of the log hazard ratio [LHR] -0.92 [-1.88, -0.01]). The CDA group also had statistically fewer secondary surgical procedures at the index levels (4.7%) than the ACDF group (17.6%) (LHR [95% BCI] -1.39 [-2.15, -0.61]) as well as at adjacent levels (9.0% vs 17.9%). CONCLUSIONS: The Prestige LP Cervical Disc, implanted at two adjacent levels, maintains improved clinical outcomes and segmental motion 10 years after surgery and is a safe and effective alternative to fusion.Clinical trial registration no.: NCT00637156 (clinicaltrials.gov)

Occurrence and clinical implications of heterotopic ossification after cervical disc arthroplasty with the Prestige LP Cervical Disc at 2 contiguous levels.

OBJECTIVE: The authors sought to assess the impact of heterotopic ossification (HO) on clinical outcomes and angular range of motion (ROM) after cervical disc arthroplasty (CDA) performed with the Prestige LP Cervical Disc (Prestige LP disc) at 2 levels. METHODS: HO was assessed and graded from 0 to IV for increasing severity on lateral neutral radiographs at each visit in 209 patients who underwent implantation of Prestige LP discs at 2 cervical levels in a clinical trial with extended 10-year follow-up. ROM was compared by using HO grade, and clinical outcomes were compared between HO subgroups (grade 0-II vs III/IV) based on HO severity at 2 and 10 years after surgery. RESULTS: The grade III/IV HO incidence at either or both index levels was 24.2% (48/198) at 2 years and 39.0% (57/146) at 10 years. No statistical difference was found in overall success; neurological success; or Neck Disability Index (NDI), neck pain, arm pain, or SF-36 Physical Component Summary (PCS) scores between the HO subgroups (grade 0-II vs III/IV) at either 2 or 10 years. The cumulative rate of possible implant-related adverse events (AEs) was higher in patients having grade III/IV HO at 2 years (56.3%) and 10 years (47.8%) compared with those having grade 0-II HO at 2 years (24.4%) and 10 years (17.9%), specifically in 2 subcategories: spinal events and HOs reported by the investigators. No statistical difference was found between the HO subgroups in possible implant-related serious AEs or secondary surgeries at the index or adjacent levels. The average angular ROMs at index levels were lower in subjects with higher-grade HO at 2 and 10 years. The average ROMs at the superior level were 8.8°, 6.6°, 3.2°, and 0.3°, respectively, for the HO grade 0/I, II, III, and IV groups at 10 years, and 7.9°, 6.2°, 3.7°, and 0.6°, respectively, at the inferior level. CONCLUSIONS: Radiographically severe (grade III or IV) HO after CDA with the Prestige LP disc at 2 levels did not significantly affect efficacy or safety outcomes (severe AEs or secondary surgeries). However, severe HO, particularly grade IV HO, significantly limited ROM, as expected

The Effect of ACDF or Arthroplasty on Cervicogenic Headaches: A Post Hoc Analysis of a Prospective, Multicenter Study With 10-Year Follow-up.

STUDY DESIGN: This was a post hoc analysis of a prospective FDA-IDE study. OBJECTIVE: The purpose of this study is to determine the effectiveness of a 2-level anterior cervical discectomy and fusion (ACDF) or cervical disk arthroplasty (CDA) at relieving headaches associated with cervical radiculopathy or myelopathy at 10 years postoperative. BACKGROUND: To our knowledge, there is no large, prospective study that has examined the efficacy of cervical spine surgery for relieving headaches associated with radiculopathy or myelopathy at 10 years postoperative. MATERIALS AND METHODS: This was a post hoc analysis of a prospective FDA-IDE study for the Prestige LP versus ACDF for radiculopathy or myelopathy due to 2 levels. Preoperatively and out to 10 years, their Neck Disability Index documented if they had headaches (0: no headaches; 1: infrequent slight; 2: infrequent moderate; 3: frequent moderate; 4: frequent severe; 5: nearly constant). RESULTS: Three hundred ninety-seven patients were randomized to CDA (209) or ACDF (188). Preoperatively 86% had headaches and 55.9% (52.2% of CDA, 60.1% of ACDFs) had frequent moderate, severe, or nearly constant headache (grades 3-5). By 6 weeks postoperative, 64.4% had headaches and only 12.5% had grades 3-5 headaches (9.3% of CDA and 16% of ACDFs). The benefit lasted to the 10-year follow-up such that 60.3% had any headaches and 16.8% had grades 3-5 headaches (10.9% CDA; 24.3% ACDF). CONCLUSIONS: These results suggest that 86% of patients with radiculopathy or myelopathy complain of headaches preoperatively, with 55.9% having frequent or constant, moderate to severe headaches (grades 3-5). By 6 weeks postoperative, only 12.5% had grades 3-5 headaches. At 10-year follow-up, 16.8% had grades 3-5 headaches. Both arthroplasty and ACDF are often effective at alleviating headaches associated with radiculopathy or myelopathy

One-Level Versus 2-Level Treatment With Cervical Disc Arthroplasty or Fusion: Outcomes Up to 7 Years.

BACKGROUND: Anterior cervical discectomy and fusion (ACDF) and cervical disc arthroplasty (CDA) have been used to treat degenerative disc disease at single as well as multiple cervical levels. This study compares the safety and efficacy of 1-level versus 2-level CDA and ACDF. METHODS: In total, 545 and 397 patients with degenerative disc disease were studied in 1-level and 2-level Food and Drug Administration (FDA)-approved clinical trials, respectively: CDA (n = 280 and 209), ACDF (n = 265 and 188). Data from these studies were used to compare 1- versus 2-level procedures: the propensity score method was used to adjust for potential confounding effects, and adjusted mean outcome safety and efficacy scores at 2 and 7 years postsurgery were compared between 1-level and 2-level procedures within treatment type. RESULTS: One-level and 2-level procedures had similar rates of improvement in overall success and patient-reported outcomes scores for both CDA and ACDF. There were no statistical differences in rates of implant-related adverse events (AEs) or serious implant-related AEs between 1-level and 2-level CDA. The 7-year rate of implant-related AEs was higher for 2-level than 1-level ACDF (27.7% vs 18.9%, CONCLUSIONS: One- and 2-level CDA appear equally safe and effective in the treatment of cervical degenerative disc disease. Two-level ACDF appears to be as effective as 1-level ACDF but with a higher rate of some AEs at long-term follow-up. LEVEL OF EVIDENCE: 2. CLINICAL TRIALS: clinicaltrials.gov: NCT00667459, NCT00642876, and NCT00637156

Impact of Cervical Disc Arthroplasty vs Anterior Cervical Discectomy and Fusion on Driving Disability: Post Hoc Analysis of a Randomized Controlled Trial With 10-Year Follow-Up.

BACKGROUND: Driving an automobile requires the ability to turn the neck laterally. Anecdotally, patients with multilevel fusions often complain about restricted turning motion. The purpose of this study was to compare the effectiveness of cervical disc arthroplasty (CDA) with anterior cervical discectomy and fusion (ACDF) on driving disability improvement at 10-year follow-up after a 2-level procedure. METHODS: In the original randomized controlled trial, patients with cervical radiculopathy or myelopathy at 2 levels underwent CDA or ACDF. The driving disability question from the Neck Disability Index was rated from 0 to 5 years preoperatively and up to 10 years postoperatively. Severity of driving disability was categorized into none (score 0), mild (1 or 2), and severe (3, 4, or 5). Score and severity were compared between groups. RESULTS: Out of 397 patients, 148 CDA and 118 ACDF patients had 10-year follow-up. Driving disability scores were not different between the groups preoperatively (CDA: 2.65; ACDF: 2.71, CONCLUSION: In patients with cervical radiculopathy/myelopathy and 2-level disease, CDA provided greater improvements in driving disability as compared with ACDF at 10-year follow-up. This is the first report of its kind. This finding may be attributable to preservation of motion associated with CDA. CLINICAL RELEVENCE: This study provides valuable information regarding the improvement of driving disability after both CDA and ACDF. It demonstrates that both procedures result in significant improvements, with CDA resulting in even better improvements than ACDF, up to 10 year follow-up