Department of Orthopaedics, West China Hospital, Sichuan University, Chengdu, China.
Department of Orthopaedics, Southwest Hospital, Third Military Medical University, Chongqing, China.
BMC Musculoskelet Disord. 2021 Nov 24;22(1):981. doi: 10.1186/s12891-021-04813-5.
The newly designed cervical disc prosthesis, Pretic-I, had been finished its limited clinical use for over 5 years. At a short-term follow-up of 2 years, we obtained satisfactory clinical results. The long-term clinical efficacy and safety of Pretic-I will now be analyzed.
Peri-operative parameters included intra-operative blood loss, operation time, off-bed time. Clinical parameters included visual analogue scale (VAS) for arm and neck, neck disability index (NDI), and Japanese Orthopaedic Association (JOA) score. Radiological parameters included C2-7 Cobb angle, Shell angle, and the range of motion (ROM) of C2-7, functional segment unit (FSU), and adjacent FSU. The CDA-related complications included adjacent segment degeneration (ASDeg), adjacent segment disease (ASDis), heterotopic ossification (HO), prosthesis subsidence, prosthesis displacement, and dysphagia.
A total 64 patients from two independent centers received a single-level CDA with Discover (n = 32) and Pretic-I (n = 32), and all of patients finished a 5-year follow-up. There're no significant differences between two groups in peri-operative parameters. The clinical parameters improved greatly in Pretic-I group (p<0.0001), and there's no statistical difference from Discover group. Furthermore, Pretic-I could slightly improve the cervical curvature (15.08 ± 11.75 to 18.00 ± 10.61, p = 0.3079) and perfectly maintain the Shell angle (3.03 ± 3.68 to 2.23 ± 4.10, p = 0.1988), cervical ROM (52.48 ± 14.31 to 53.30 ± 11.71, p = 0.8062) and FSU ROM (12.20 ± 4.52 to 10.73 ± 4.45, p = 0.2002). The incidence of high-grade HO (Grade III-IV) at the final follow-up was significantly lower in Pretic-I group than in Discover group (12.50% vs. 34.38%, p = 0.0389, Statistical Power = 95.36%). The incidences of other CDA-related complications in Pretic-I group were also well-accepted, comparable to the Discover group, without significant differences.
CDA with Pretic-I demonstrated a well-accepted and sustained clinical outcome, with a significantly lower incidence of high-grade HO. This newly designed prosthesis is expected to become an alternative choice for cervical disc prosthesis in the future.
新设计的颈椎间盘假体 Pretic-I 已经完成了超过 5 年的有限临床应用。在为期 2 年的短期随访中，我们获得了满意的临床结果。现在将分析 Pretic-I 的长期临床疗效和安全性。
围手术期参数包括术中出血量、手术时间、离床时间。临床参数包括手臂和颈部的视觉模拟量表（VAS）、颈部残疾指数（NDI）和日本矫形协会（JOA）评分。影像学参数包括 C2-7 Cobb 角、Shell 角以及 C2-7 的活动范围（ROM）、功能节段单位（FSU）和相邻 FSU。CDA 相关并发症包括相邻节段退变（ASDeg）、相邻节段疾病（ASDis）、异位骨化（HO）、假体下沉、假体移位和吞咽困难。
来自两个独立中心的 64 名患者接受了单节段 CDA，其中 Discover（n=32）和 Pretic-I（n=32），所有患者均完成了 5 年随访。两组在围手术期参数方面无显著差异。Pretic-I 组的临床参数有很大改善（p<0.0001），与 Discover 组无统计学差异。此外，Pretic-I 可略微改善颈椎曲度（15.08±11.75 至 18.00±10.61，p=0.3079），并完美维持 Shell 角（3.03±3.68 至 2.23±4.10，p=0.1988）、颈椎 ROM（52.48±14.31 至 53.30±11.71，p=0.8062）和 FSU ROM（12.20±4.52 至 10.73±4.45，p=0.2002）。末次随访时，Pretic-I 组高级别 HO（III-IV 级）的发生率明显低于 Discover 组（12.50%比 34.38%，p=0.0389，统计效力=95.36%）。Pretic-I 组其他 CDA 相关并发症的发生率也得到了很好的接受，与 Discover 组相比无显著差异。
CDA 联合 Pretic-I 具有良好的可接受性和持续的临床效果，高级别 HO 的发生率显著降低。这种新设计的假体有望成为未来颈椎间盘假体的替代选择。
