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棘突间减压装置的失败率和并发症:一项欧洲多中心研究。

Failure rates and complications of interspinous process decompression devices: a European multicenter study.

作者信息

Gazzeri Roberto, Galarza Marcelo, Neroni Massimiliano, Fiore Claudio, Faiola Andrea, Puzzilli Fabrizio, Callovini Giorgio, Alfieri Alex

机构信息

Department of Neurosurgery, San Giovanni Addolorata Hospital;

Regional Service of Neurosurgery, "Virgen de la Arrixaca" University Hospital, Murcia, Spain; and.

出版信息

Neurosurg Focus. 2015 Oct;39(4):E14. doi: 10.3171/2015.7.FOCUS15244.

DOI:10.3171/2015.7.FOCUS15244
PMID:26424338
Abstract

OBJECT Spacers placed between the lumbar spinous processes represent a promising surgical treatment alternative for a variety of spinal pathologies. They provide an unloading distractive force to the stenotic motion segment, restoring foraminal height, and have the potential to relieve symptoms of degenerative disc disease. The authors performed a retrospective, multicenter nonrandomized study consisting of 1108 patients to evaluate implant survival and failure modes after the implantation of 8 different interspinous process devices (IPDs). METHODS The medical records of patients who had undergone placement of an IPD were retrospectively evaluated, and demographic information, diagnosis, and preoperative pain levels were recorded. Preoperative and postoperative clinical assessments in the patients were based on the visual analog scale. A minimum of 3 years after IPD placement, information on long-term outcomes was obtained from additional follow-up or from patient medical and radiological records. RESULTS One thousand one hundred eight patients affected by symptomatic 1- or 2-level segmental lumbar spine degenerative disease underwent placement of an IPD. The complication rate was 7.8%. There were 27 fractures of the spinous process and 23 dura mater tears with CSF leakage. The ultimate failure rate requiring additional surgery was 9.6%. The reasons for revision, which always involved removal of the original implant, were acute worsening of low-back pain or lack of improvement (45 cases), recurrence of symptoms after an initial good outcome (42 cases), and implant dislocation (20 cases). CONCLUSIONS The IPD is not a substitute for a more invasive 3-column fusion procedure in cases of major instability and spondylolisthesis. Overdistraction, poor bone density, and poor patient selection may all be factors in the development of complications. Preoperatively, careful attention should be paid to bone density, appropriate implant size, and optimal patient selection.

摘要

目的

置于腰椎棘突之间的间隔器代表了一种针对多种脊柱病变颇具前景的手术治疗选择。它们为狭窄的运动节段提供卸载牵张力,恢复椎间孔高度,并有可能缓解椎间盘退变疾病的症状。作者进行了一项回顾性、多中心非随机研究,纳入1108例患者,以评估8种不同棘突间装置(IPD)植入后的植入物存活率和失效模式。方法:对接受IPD植入的患者病历进行回顾性评估,记录人口统计学信息、诊断和术前疼痛水平。患者术前和术后的临床评估基于视觉模拟量表。在IPD植入至少3年后,通过额外随访或患者的医疗和放射学记录获取长期结果信息。结果:1108例有症状的1或2节段性腰椎退变疾病患者接受了IPD植入。并发症发生率为7.8%。有27例棘突骨折和23例硬脑膜撕裂伴脑脊液漏。需要再次手术的最终失败率为9.6%。翻修的原因总是涉及取出原植入物,包括腰背痛急性加重或无改善(45例)、最初效果良好后症状复发(42例)以及植入物脱位(20例)。结论:在严重不稳定和椎体滑脱的情况下,IPD不能替代更具侵入性的三柱融合手术。过度牵张、骨密度差和患者选择不当可能都是并发症发生的因素。术前应仔细关注骨密度、合适的植入物尺寸和最佳的患者选择。

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