Five-year results of cervical disc prostheses in the SWISSspine registry
Five-year results of cervical disc prostheses in the SWISSspine registry
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DOI：
10.1007/s00586-013-2770-0
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发表时间：
2013-08-01
影响因子：
2.8
通讯作者：
Roeder, Christoph
中科院分区：
文献类型：
--
作者：
Aghayev, Emin;Baerlocher, Christian;Roeder, Christoph
瑞士联邦公共卫生办公室要求对颈椎全椎间盘置换术（TDA）进行全国性的HTA登记，以决定其报销问题。SWISS脊柱登记研究的目的是为颈椎TDA的安全性和有效性提供证据，研究纳入了2005年3月至2006年6月期间接受治疗的332例患者，这些患者符合5年随访的条件。3-6个月、1年、2年、5年随访率分别为84.6%、74.4%、50.6%、64.8%。结果指标包括颈部和手臂疼痛、药物治疗、生活质量、术中和术后并发症以及翻修率。此外，在5年随访时分析节段活动度、骨化、邻近和远节段退变。具有临床意义且持续的颈部复位（术前/术后60/21 VAS分）和手臂疼痛（术前/术后VAS 67/17），因此镇痛药用量减少，生活质量改善（术前/术后0.39/0.82 EQ-5D分）直至5年随访。术中和术后早期并发症的发生率分别为0.6%和7.2%。0.6%的患者进行了早期翻修手术，3.9%的患者进行了晚期翻修手术。5年随访时，移动的节段（88.2%）的平均活动度为10.2 A度。在40.7%的患者中观察到至少潜在影响活动范围的骨赘。颈椎TDA在长期缓解疼痛、减少止痛药消耗和改善生活质量方面安全有效。在术后5年内，改善是稳定的。绝大多数治疗节段在5年后仍保持移动的，尽管40.7%的患者显示骨赘。
The Swiss Federal Office of Public Health demanded a nationwide HTA-registry for cervical total disc arthroplasty (TDA), to decide about its reimbursement. The goal of the SWISSspine registry is to generate evidence about the safety and efficiency of cervical TDA.Three hundred thirty-two cases treated between 3.2005 and 6.2006 who were eligible for 5 years follow-ups were included in the study. Follow-up rates for 3-6 months, 1, 2 and 5 years were 84.6, 74.4, 50.6 and 64.8 %, respectively. Outcome measures were neck and arm pain, medication, quality of life, intraoperative and postoperative complication and revision rates. In addition, segmental mobility, ossification, adjacent and distant segment degeneration were analyzed at the 5-year follow-up.There was significant, clinically relevant and lasting reduction of neck (preop/postop 60/21 VAS points) and arm pain (preop/postop VAS 67/17) and a consequently decreased analgesics consumption and quality of life improvement (preop/postop 0.39/0.82 EQ-5D points) until the 5-year follow-up. The rates for intraoperative and early postoperative complications were 0.6 and 7.2 %, respectively. In 0.6 % an early and in 3.9 % a late revision surgery was performed. At the 5-year follow-up, the average range of motion of the mobile segments (88.2 %) was 10.2A degrees. In 40.7 % of the patients osteophytes at least potentially affecting range of motion were seen.Cervical TDA appeared as safe and efficient in long-term pain alleviation, consequent reduction of pain killer consumption and in improvement of quality of life. The improvement is stable over the 5 years postoperative period. The vast majority of treated segments remained mobile after 5 years, although 40.7 % of patients showed osteophytes.