1Department of Neurosurgery, National Hospital for Neurology and Neurosurgery, University College London Hospitals, London.
2UCL Cancer Institute, University College London; and.
J Neurosurg Spine. 2021 Feb 2;34(4):544-552. doi: 10.3171/2020.7.SPINE20880. Print 2021 Apr 1.
Lumbar spinal stenosis (LSS) is a common and debilitating condition that is increasing in prevalence in the world population. Surgical decompression is often standard treatment when conservative measures have failed. Interspinous distractor devices (IDDs) have been proposed as a safe alternative; however, the associated cost and early reports of high failure rates have brought their use into question. The primary objective of this study was to determine the cost-effectiveness and long-term quality-of-life (QOL) outcomes after treatment of LSS with the X-Stop IDD compared with surgical decompression by laminectomy.
A multicenter, open-label randomized controlled trial of 47 patients with LSS was conducted; 21 patients underwent insertion of the X-Stop device and 26 underwent laminectomy. The primary outcomes were monetary cost and QOL measured using the EQ-5D questionnaire administered at 6-, 12-, and 24-month time points.
The mean monetary cost for the laminectomy group was £2712 ($3316 [USD]), and the mean cost for the X-Stop group was £5148 ($6295): £1799 ($2199) procedural cost plus £3349 mean device cost (£2605 additional cost per device). Using an intention-to-treat analysis, the authors found that the mean quality-adjusted life-year (QALY) gain for the laminectomy group was 0.92 and that for the X-Stop group was 0.81. The incremental cost-effectiveness ratio was -£22,145 (-$27,078). The revision rate for the X-Stop group was 19%. Five patients crossed over to the laminectomy arm after being in the X-Stop group.
Laminectomy was more cost-effective than the X-Stop for the treatment of LSS, primarily due to device cost. The X-Stop device led to an improvement in QOL, but it was less than that in the laminectomy group. The use of the X-Stop IDD should be reserved for cases in which a less-invasive procedure is required. There is no justification for its regular use as an alternative to decompressive surgery. Clinical trial registration no.: ISRCTN88702314 (www.isrctn.com).
腰椎管狭窄症（LSS）是一种常见且使人虚弱的疾病，在世界人群中的发病率正在上升。当保守治疗失败时，手术减压通常是标准治疗方法。棘突间撑开器（IDD）已被提议作为一种安全的替代方法；然而，其相关成本和早期高失败率的报告使其使用受到质疑。本研究的主要目的是确定与减压性椎板切除术相比，使用 X-Stop IDD 治疗 LSS 的成本效益和长期生活质量（QOL）结果。
对 47 例 LSS 患者进行了多中心、开放标签、随机对照试验；21 例患者接受 X-Stop 装置插入，26 例患者接受椎板切除术。主要结局指标是在 6、12 和 24 个月时间点使用 EQ-5D 问卷测量的货币成本和 QOL。
椎板切除术组的平均货币成本为 2712 英镑（3316 美元），X-Stop 组的平均成本为 5148 英镑（6295 美元）：手术程序费用为 1799 英镑（2199 美元），外加 X-Stop 装置的平均费用 3349 英镑（每台装置额外费用 2605 英镑）。采用意向治疗分析，作者发现椎板切除术组的平均质量调整生命年（QALY）增益为 0.92，X-Stop 组为 0.81。增量成本效益比为-22145 英镑（-27078 美元）。X-Stop 组的翻修率为 19%。5 名患者在 X-Stop 组后交叉到椎板切除术组。
与 X-Stop 相比，椎板切除术治疗 LSS 更具成本效益，主要原因是设备成本。X-Stop 装置改善了 QOL，但不如椎板切除术组。X-Stop IDD 的使用应保留在需要微创手术的情况下。没有理由将其常规用作减压手术的替代方法。临床试验注册号：ISRCTN88702314（www.isrctn.com）。
