Aghayev Emin, Etter Christian, Bärlocher Christian, Sgier Friedrich, Otten Philippe, Heini Paul, Hausmann Oliver, Maestretti Gianluca, Baur Martin, Porchet François, Markwalder Thomas M, Schären Stefan, Neukamp Michal, Röder Christoph
Institute for Evaluative Research in Medicine, Stauffacherstrasse 78, 3014, Bern, Switzerland,
Eur Spine J. 2014 Oct;23(10):2114-26. doi: 10.1007/s00586-014-3418-4. Epub 2014 Jun 20.
The Swiss Federal Office of Public Health demanded a nationwide HTA registry for lumbar total disc arthroplasty (TDA), to decide about its reimbursement. The goal of the SWISS spine registry is to generate evidence about the safety and efficiency of lumbar TDA.
Two hundred forty-eight cases treated between 3-2005 and 6-2006, who were eligible for the 5-year follow-up were included in the study. Follow-up rates for 3-6 months, 1, 2 and 5 years were 85.9, 77.0, 44.0 and 51.2 %, respectively. Outcome measures were back and leg pain, medication consumption, quality of life, intraoperative and postoperative complication and revision rates. Additionally, segmental mobility, ossification, adjacent and distant segment degeneration were analysed at the 5-year follow-up.
There was a significant, clinically relevant and lasting reduction of back (preop/postop 73/29 VAS points) and leg pain (preop/postop VAS 55/22) and a consequently decreased analgesics consumption and quality of life improvement (preop/postop 0.30/0.76 EQ-5D score points) until 5 years after surgery. The rates for intraoperative and early postoperative complications were 4.4 and 3.2 %, respectively. The overall complication rate during five postoperative years was 23.4 %, and the adjacent segment degeneration rate was 10.7 %. In 4.4 % of patients, a revision surgery was performed. Cumulative survivorship probability for a revision/re-intervention-free 5-year postoperative course was 90.4 %. At the 5-year follow-up, the average range of motion of the mobile segments (86.8 %) was 9.7°. In 43.9 % of patients, osteophytes at least potentially affecting the range of motion were seen.
Lumbar TDA appeared as efficient in long-term pain alleviation, consequent reduction of pain medication consumption and improvement of quality of life. The procedure also appeared sufficiently safe, but surgeons have to be aware of a list of potential adverse events. The outcome is stable over the 5-year postoperative period. The vast majority of treated segments remained mobile after 5 years, although almost half of patients showed osteophytes.
瑞士联邦公共卫生局要求建立一个全国性的腰椎全椎间盘置换术（TDA）卫生技术评估登记系统，以决定是否对其进行报销。瑞士脊柱登记系统的目标是收集有关腰椎TDA安全性和有效性的证据。
纳入2005年3月至2006年6月期间接受治疗且符合5年随访条件的248例患者。3至6个月、1年、2年和5年的随访率分别为85.9%、77.0%、44.0%和51.2%。观察指标包括腰腿痛、药物消耗、生活质量、术中和术后并发症及翻修率。此外，在5年随访时分析节段活动度、骨化、相邻节段和远处节段退变情况。
术后5年内，腰背痛（术前/术后视觉模拟评分[VAS]73/29分）和腿痛（术前/术后VAS 55/22分）显著、具有临床意义且持续减轻，镇痛药消耗相应减少，生活质量得到改善（术前/术后欧洲五维健康量表[EQ-5D]评分0.30/0.76分）。术中和术后早期并发症发生率分别为4.4%和3.2%。术后5年的总体并发症发生率为23.4%，相邻节段退变率为10.7%。4.4%的患者接受了翻修手术。术后5年无翻修/再次干预的累积生存率为90.4%。在5年随访时，活动节段的平均活动范围（86.8%）为9.7°。43.9%的患者可见至少潜在影响活动范围的骨赘。
腰椎TDA在长期缓解疼痛、减少镇痛药消耗和改善生活质量方面似乎是有效的。该手术似乎也足够安全，但外科医生必须了解一系列潜在不良事件。术后5年的结果稳定。尽管近一半的患者出现了骨赘，但绝大多数治疗节段在5年后仍保持活动。
