Clinical and radiographic analysis of an artificial cervical disc: 7-year follow-up from the Prestige prospective randomized controlled clinical trial

Abstract

<jats:sec> <jats:title>Object</jats:title> <jats:p>The authors assess the long-term safety and efficacy of cervical disc replacement with the Prestige Cervical Disc in a prospective, randomized, multicenter trial at 7 years of follow-up.</jats:p></jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>At 31 investigational sites, 541 patients with single-level cervical disc disease with radiculopathy were randomized to 1 of 2 treatment groups: 276 investigational group patients underwent anterior cervical discectomy and arthroplasty with the Prestige disc, and 265 control group patients underwent anterior cervical discectomy and fusion. Clinical outcomes included Neck Disability Index, the 36-Item Short-Form Health Survey, and neck and arm pain scores. Radiographs were assessed for angle of motion and fusion. Clinical and radiographic outcomes were evaluated preoperatively, intraoperatively, and at 1.5, 3, 6, 12, 24, 36, 60, and 84 months.</jats:p></jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>Of the 541 patients treated, 395 patients (73%; 212 investigational and 183 control patients) completed 7 years of clinical follow-up. Significant improvements achieved by 1.5 months in both groups were sustained at 7 years. In the investigational group, mean Neck Disability Index improvements from preoperative scores were 38.2 and 37.5 at 60 and 84 months, respectively. In the control group, the corresponding means were 33.8 and 31.9. The differences between the investigational and control groups at the 60-month and 84-month periods were significant (p = 0.014 and 0.002, respectively). The overall rates of maintenance or improvement in neurological status in the investigational group were significantly higher: 92.2% and 88.2% at 60 months and 84 months, respectively, compared with 85.7% and 79.7% in the control group (p = 0.017 and 0.011, respectively). At 84 months, the percentage of working patients in the investigational group was 73.9%, and in the control group, 73.1%. Postoperatively, the implant effectively maintained average angular motion of 6.67° at 60 months and 6.75° at 84 months. Cumulative rates for surgery at the index level were lower (p &lt; 0.001) in the investigational group (11 [4.8%] of 276) when compared with the control group (29 [13.7%] of 265) (based on life-table method), and there were statistical differences between the investigational and control groups with specific regard to the rate of subsequent revision and supplemental fixation surgical procedures. Rates for additional surgical procedures that involved adjacent levels were lower in the investigational group than in the control group (11 [4.6%] of 276 vs 24 [11.9%] of 265, respectively).</jats:p></jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>Cervical disc arthroplasty has the potential for preserving motion at the operated level while providing biomechanical stability and global neck mobility and may result in a reduction in adjacent-segment degeneration. The Prestige Cervical Disc maintains improved clinical outcomes and segmental motion after implantation at 7-year follow-up. Clinical trial registration no. NCT00642876 (<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="ClinicalTrials.gov" ext-link-type="uri" xlink:type="simple">ClinicalTrials.gov</jats:ext-link>).</jats:p></jats:sec>

Reoperation After Cervical Disc Arthroplasty Versus Anterior Cervical Discectomy and Fusion: A Meta-analysis

“…Supplemental material is available with the online version of CORR 1 .). Finally, 12 eligible RCTs were included in our systematic review and meta-analysis [5,8,10,22,30,34,35,37,38,[42][43][44]. The study selection is shown in the PRISMA flowchart (Fig.…”

“…All 12 studies included in this meta-analysis were parallelgroup randomized trials, eight were conducted in the United States [5,8,10,22,30,35,38,44], and the other four were done in Asia and Europe [34,37,42,43] ( Table 1). The years of publication ranged from 2011 to 2015, and the lengths of followup ranged from 2 to 7 years.…”

“…During the past decade, the cervical disc arthroplasty has emerged as an alternative to fusion and has been shown to provide the pain relief and functional improvements similar or superior to those of anterior cervical discectomy and fusion in FDA Investigational Device Exemption clinical trials [5,8,10,22,30,32,35,38,44]. Owing to its biomechanical advantages, the cervical disc arthroplasty may be associated with less adjacent-segment degeneration.…”

“…Reoperation after cervical disc arthroplasty has been attracting the attention of investigators since several cervical artificial discs have received FDA approval for implantation. Some FDA Investigational Device Exemption trials and a retrospective study have suggested that patients who underwent cervical disc arthroplasty had fewer reoperations than those treated with anterior cervical discectomy and fusion [5,10,22,31,38,44]. However, two other FDA Investigational Device Exemption trials showed that the secondary surgical procedures were not significantly different between the two groups at 24 months [8,19] and longer-term followups [35].…”

CORR Insights®: Reoperation After Cervical Disc Arthroplasty Versus Anterior Cervical Discectomy and Fusion: A Meta-analysis

“…However, these findings have not been consistent. Some studies show no difference between anterior cervical discectomy and fusion and cervical disc replacement, while others demonstrate superiority of cervical disc replacement [2,4,5].…”