Department of Neurological Surgery and the Miami Project to Cure Paralysis, University of Miami Miller School of Medicine/Jackson Memorial Hospital, Miami, Florida.
Department of Orth-opedic Surgery, SUNY Upstate Medical University, Syracuse, New York.
Neurosurgery. 2019 Feb 1;84(2):347-354. doi: 10.1093/neuros/nyy118.
Ten-year follow-up data from the US Food and Drug Administration investigational device exemption trial comparing BRYAN® Cervical Disc (Medtronic, Dublin, Ireland) arthroplasty to anterior cervical discectomy and fusion (ACDF) demonstrated that disc arthroplasty maintained range of motion and improvements in overall success and neck disability.
To compare the 10-yr rates of symptomatic adjacent level disease requiring surgery (SALDRS).
Prospective randomized trial data were analyzed comparing BRYAN® Cervical Disc arthroplasty to ACDF for single-level cervical disc disease with concordant radiculopathy or myelopathy with clinicoradiographic analysis at 10 yr. Secondarily, 84-mo data were pooled with PRESTIGE® Cervical Disc arthroplasty (Medtronic) study data to provide overall rates of SALDRS.
Significantly greater overall success was maintained at every postoperative interval with an overall success rate of 81.3% with BRYAN® disc and 66.3% with ACDF (P = .005) without loss of motion preservation (8.69° vs 0.60°). Reoperation at adjacent levels up to the 120-mo visit was 9.7% in the arthroplasty group and 15.8% in the ACDF group (P = .146). The combined data from BRYAN® and Prestige ST demonstrate that BRYAN® and Prestige disc groups had a lower rate of second surgeries at the adjacent levels, up to the 84-mo visit, compared to the combined ACDF groups (6.9% vs 11.7%; P = .023).
Compared with ACDF, fewer patients with the BRYAN® disc required surgery for symptomatic adjacent level degeneration, but this did not achieve statistical significance. Analysis of combined study data using Bryan and Prestige discs shows significant differences in SADLRS as early as 7 yr.
美国食品和药物管理局的一项研究性设备豁免试验的 10 年随访数据显示，BRYAN®颈椎间盘（爱尔兰都柏林美敦力公司）置换术与前路颈椎间盘切除融合术（ACDF）相比，能维持活动范围，并提高整体成功率和颈部残疾程度。
比较需要手术的症状性邻近节段疾病（SALDRS）的 10 年发生率。
前瞻性随机试验数据进行分析，比较 BRYAN®颈椎间盘置换术与 ACDF 治疗单节段颈椎间盘疾病伴神经根病或脊髓病，在 10 年时进行临床和影像学分析。其次，将 84 个月的数据与 PRESTIGE®颈椎间盘置换术（美敦力）研究数据汇总，以提供 SALDRS 的总体发生率。
BRYAN®椎间盘的总体成功率始终保持显著更高，在每个术后间隔的总体成功率为 81.3%，而 ACDF 的总体成功率为 66.3%（P=0.005），同时保持活动度的保留（8.69°与 0.60°）。在相邻节段的再手术率在 120 个月访视时为 9.7%，在 ACDF 组为 15.8%（P=0.146）。BRYAN®和 Prestige ST 的综合数据表明，BRYAN®和 Prestige 椎间盘组在相邻节段的二次手术率较低，在 84 个月的随访时，与 ACDF 组相比（6.9%与 11.7%；P=0.023）。
与 ACDF 相比，BRYAN®椎间盘治疗的患者中，因症状性邻近节段退变需要手术的患者较少，但这并未达到统计学意义。使用 Bryan 和 Prestige 椎间盘分析联合研究数据显示，早在 7 年时，SALDRS 就有显著差异。
