Abjornson Celeste, Yoon Byung-Jo Victor, Callanan Tucker, Shein Daniel, Grinberg Samuel, Cammisa Frank P
Hospital for Special Surgery, New York, NY, USA.
Int J Spine Surg. 2018 Mar 30;12(1):64-69. doi: 10.14444/5011. eCollection 2018 Jan.
In the absence of spondylolisthesis, fusion procedures are generally not recommended. However, decompression alone often does not provide long-term clinical success of intractable leg and back pain. Decompression with interlaminar stabilization (ILS) offers a new option within the clinical continuum of care by providing a nonfusion surgical alternative. The objective of this study is to examine the sustainability of decompression with ILS and to understand the clinical success at either 1 or 2 levels as a surgical treatment for nonspondylolisthesis patients with spinal stenosis.
Under an FDA-regulated investigational device exemption (IDE) study, a total of 322 patients were enrolled in the prospective, randomized trial. This investigation focuses only on the subset of patients (116 total) from this overall cohort who were treated with decompression plus ILS at 1 or 2 levels and who did not present with spondylolisthesis preoperatively. The patients were assessed before and after surgery up to 60 months.
At 60-month follow up, there was no statistically significant difference in ODI ≥ 15 point improvement between patient populations (81.6% of 1 level, 90.3% of 2 level). At 60 months, 83.1% of 1 level and 86.3% of 2 level patients did not require a secondary surgical procedure. At 60 months, 94.7% of 1 level and 100% of 2 level reported ≥20 mm improvement in Visual Analogue Scale leg pain. Patients reported improvement in their physical state according to Short Form-12 scores (89.3% of 1 level, 88.9% of 2 level). Patient satisfaction at 60 months was 97.4% for 1 level and 93.3% for 2 level.
The therapeutic sustainability for the treatment of spinal stenosis without spondylolisthesis with ILS at 1 or 2 levels in the lumbar region has been shown to be safe and efficacious for patients who have failed conservative treatment.
Decompression with ILS offers a nonterminal surgical option for the treatment of the symptomology of spinal stenosis, a progressive degenerative condition, that potentially can provide longer durability and stability than decompression alone.
在不存在椎体滑脱的情况下，通常不建议进行融合手术。然而，单纯减压往往无法长期有效地缓解顽固性腿痛和背痛。椎板间稳定化减压术（ILS）通过提供一种非融合手术替代方案，在临床连续护理中提供了一种新选择。本研究的目的是检验ILS减压的可持续性，并了解作为治疗非椎体滑脱性椎管狭窄患者的手术方法，在一个或两个节段进行手术的临床成功率。
在一项由美国食品药品监督管理局（FDA）监管的研究器械豁免（IDE）研究中，共有322例患者参加了这项前瞻性随机试验。本调查仅关注该总体队列中的一部分患者（共116例），这些患者在一个或两个节段接受了减压加ILS治疗，且术前不存在椎体滑脱。对患者在术前及术后长达60个月的时间进行评估。
在60个月的随访中，不同患者群体之间在ODI改善≥15分方面无统计学显著差异（单节段患者为81.6%，双节段患者为90.3%）。在60个月时，单节段患者中有83.1%、双节段患者中有86.3%不需要二次手术。在60个月时，单节段患者中有94.7%、双节段患者中有100%报告视觉模拟量表腿痛改善≥20 mm。患者根据简短健康调查问卷-12评分报告身体状况有所改善（单节段患者为89.3%，双节段患者为88.9%）。60个月时单节段患者的满意度为97.4%；双节段患者为93.3%。
对于保守治疗失败的患者，已证明在腰椎一个或两个节段采用ILS治疗无椎体滑脱的椎管狭窄具有安全有效性。
ILS减压为治疗椎管狭窄症状提供了一种非终末性手术选择，椎管狭窄是一种进行性退行性疾病，与单纯减压相比，它可能具有更长的耐用性和稳定性。
