中国修复重建外科杂志

中国修复重建外科杂志

Prodisc-C 假体行全颈椎人工间盘置换术后远期疗效评估

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目的 对 Prodisc-C 假体行全颈椎人工间盘置换术(total cervical disc replacement,TDR)患者 10 年以上远期疗效进行评价。 方法 回顾分析 2005 年 12 月—2008 年 4 月采用 Prodisc-C 假体行 TDR 治疗的 118 例单节段至 3 节段颈椎间盘退变疾病(cervical disc degeneration disease,CDDD)患者临床资料。其中男 66 例,女 52 例;年龄 25~62 岁,平均 46.8 岁。神经根型颈椎病 38 例,脊髓型颈椎病 28 例,混合型颈椎病 52 例。手术节段为 C3~7,其中单节段 90 例,连续双节段 20 例,连续 3 节段 8 例。术中共使用 154 个 Prodisc-C 假体。手术前后临床疗效采用疼痛视觉模拟评分(VAS)、颈椎功能障碍指数(NDI)、日本骨科协会(JOA)评分、Odom 分级评价。影像学评价指标包括颈椎活动度(range of motion,ROM)、矢状位前凸角、椎间隙高度(intervertebral disc height,IDH),并观察有无假体移位、下沉、松动、锁死及异位骨化(heterotopic ossification,HO)、邻近节段退变(adjacent segment degeneration,ASD)等并发症发生。并根据有无发生 HO 或 ASD 分组,比较患者手术节段 ROM。 结果 术后患者均获随访,随访时间 121~150 个月,平均 135.8 个月。随访期间无 1 例行翻修手术。术后 1 周及末次随访时 VAS、NDI、JOA 评分及 Odom 分级均较术前显著改善(P<0.05);其中末次随访时 VAS 和 NDI 较术后 1 周进一步改善(P<0.05);术后 1 周及末次随访时的 JOA 评分及改善率比较差异无统计学意义(P>0.05)。颈椎整体和手术节段 ROM 在术后 1 周和 10 年后较术前有所减小(P<0.05),其余各时间点差异均无统计学意义(P>0.05);上位邻近节段(upper adjacent segment,UAS)和下位邻近节段(lower adjacent segment,LAS)的 ROM 术后各时间点间比较差异均无统计学意义(P>0.05)。手术前后各时间点颈椎矢状位前凸角比较差异均无统计学意义(P>0.05);手术节段前凸角在术后 1 周、6 个月、1 年、2 年较术前显著增加(P<0.05)。术后各时间点手术节段 IDH 均较术前显著改善(P<0.05),而术后各时间点间 UAS 和 LAS 的 IDH 比较差异均无统计学意义(P>0.05)。术后各时间点均未发生假体移位、下沉和松动;从术后 6 个月起,各时间点间假体移位和下沉距离比较差异均无统计学意义(P>0.05)。而末次随访时假体锁死/融合发生率(10.4%)与术后 6 个月(1.9%)比较差异有统计学意义(P<0.05)。术后 1 周上位 ASD 和下位 ASD 发生率分别为 1.3% 和 2.6%,随时间延长其发生率逐渐增加,各时间点间比较差异均有统计学意义(P<0.05);ASD 组患者术后各时间点手术节段 ROM 均低于无 ASD 组,但差异无统计学意义(P>0.05)。术后 6 个月起有 58.4% 节段出现 HO,随时间延长 HO 发生率均较术后 6 个月逐渐显著增加(P<0.05);HO 组患者手术节段 ROM 在术后 6 个月、2 年、5 年、10 年显著小于无 HO 组患者(P<0.05)。 结论 TDR 术后对邻近节段影响较小,尽管出现部分影像学并发症,但对整体临床疗效的改善无明显影响;使用 Prodisc-C 假体行 TDR 治疗 CDDD 可获得远期安全、明确的临床疗效。

Objective To evaluate long-term radiographic and clinical effectiveness of total cervical disc replacement (TDR) with Prodisc-C prosthesis at a minimum of 10 years follow-up. Methods The clinical data of 118 patients with cervical disc degeneration disease (CDDD) treated with TDR using Prodisc-C prosthesis between December 2005 and April 2008 were retrospectively analyzed. There were 66 males and 52 females, with an average age of 25-62 years (mean, 46.8 years). There were 38 cases of cervical spondylotic radiculopathy, 28 cases of cervical spondylotic myelopathy, and 52 cases of mixed cervical spondylotic myelopathy. The operative segments were C3-7, including 90 cases of single segment, 20 cases of continuous double segments, and 8 cases of continuous three segments. A total of 154 Prodisc-C prostheses were used during the operation. The clinical effectiveness was evaluated by pain visual analogue scale (VAS) score, neck disability index (NDI), Japanese Orthopaedic Association (JOA) score, and Odom grade before and after operation. Imaging evaluation indicators included range of motion (ROM), sagittal lordosis angle, intervertebral disc height (IDH), and prosthesis displacement, subsidence, loosening, locking, and heterotopic ossification (HO), adjacent segment degeneration (ASD), and other complications. According to the occurrence of HO or ASD, the ROM of surgical segment was compared. Results All patients were followed up 121-150 months (mean, 135.8 months). No revision operation was performed during the follow-up period. The VAS, NDI, JOA scores and Odom grades were significantly improved at 1 week after operation and last follow-up when compared with preoperative ones (P<0.05); VAS and NDI scores were further improved at last follow-up than at 1 week after operation (P<0.05); there was no significant difference in JOA scores and improvement rates between at 1 week after operation and last follow-up (P>0.05). The ROM of the whole cervical spine and the operative segment decreased at 1 week and 10 years after operation when compared with preoperative ones (P<0.05), but there was no significant difference in the other time points (P>0.05); there was no significant difference between the upper adjacent segment (UAS) and the lower adjacent segment (LAS) at each time point after operation (P>0.05). There was no significant difference in sagittal lordosis angle of cervical spine before and after operation (P>0.05); the sagittal lordosis angle of operative segment increased significantly at 1 week, 6 months, 1 year, and 2 years after operation (P<0.05). The IDH of operative segment was significantly improved at each time point after operation (P<0.05), but there was no significant difference of IDH between UAS and LAS at each time point after operation (P>0.05). No prosthesis displacement, subsidence, or loosening occurred at each time point after operation. There was no significant difference of the prosthetic displacement and subsidence distance between all time points after 6 months after operation (P>0.05). At last follow-up, there was a significant difference in the incidence of prosthetic locking/fusion (10.4%) when compared with 6 months (1.9%) (P<0.05). The incidence of upper ASD and lower ASD was 1.3% and 2.6% respectively at 1 week after operation. The incidence of upper ASD and lower ASD increased gradually with time prolonging, and there were significant differences between different time points (P<0.05). The ROM of operative segment in ASD group was lower than that in non-ASD group at each time point after operation, but there was no significant difference (P>0.05). HO appeared in 58.4% of the segments at 6 months after operation, and the incidence of HO increased significantly with time, which was significantly different from that at 6 months after operation (P<0.05). The ROM of operative segments in HO group was significantly lower than that in non-HO group at 6 months, 2 years, 5 years, and 10 years after operation (P<0.05). Conclusion TDR has little effect on adjacent segments, although there are some imaging complications, it has no significant effect on the improvement of overall clinical effectiveness. Prodisc-C prosthesis can provide long-term, safe, and definite clinical effectiveness in the treatment of CDDD.

关键词: Prodisc-C假体; 全颈椎人工间盘置换术; 远期疗效

Key words: Prodisc-C prosthesis; total cervical disc replacement; long-term effectiveness

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