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后路腰椎椎间融合同种异体骨移植治疗腰椎退行性椎间盘疾病的临床疗效:一项为期2年随访的前瞻性多中心试验。

Clinical outcomes of lumbar degenerative disc disease treated with posterior lumbar interbody fusion allograft spacer: a prospective, multicenter trial with 2-year follow-up.

作者信息

Arnold Paul M, Robbins Stephen, Paullus Wayne, Faust Stephen, Holt Richard, McGuire Robert

机构信息

Department of Neurosurgery, University of Kansas Medical Center, Kansas City, KS 66160, USA.

出版信息

Am J Orthop (Belle Mead NJ). 2009 Jul;38(7):E115-22.

PMID:19714280
Abstract

The clinical benefits and complications of posterior lumbar interbody fusion (PLIF) have been studied over the past 60 years. In recent years, spine surgeons have had the option of treating low back pain caused by degenerative disc disease using PLIF with machined allograft spacers and posterior pedicle fixation. The purpose of this clinical series was to assess the clinical benefits of using a machined PLIF allograft spacer and posterior pedicle fixation to treat degenerative disc disease, both in terms of fusion rates and patient outcomes, and to compare these results with those in previous studies using autograft and metal interbody fusion devices. Results were also compared with results from studies using transverse process fusion. This prospective, nonrandomized clinical series was conducted at 10 US medical centers. Eighty-nine (55 male, 34 female) patients underwent PLIF with a presized, machined allograft spacer and posterior pedicle fixation between January 2000 and April 2003. Their outcomes were compared with outcomes in previous series described in the literature. All patients had experienced at least 6 months of low back pain that had been unresponsive to nonsurgical treatment. Physical examinations were performed before surgery, after surgery, and at 4 follow-up visits (6 weeks, 6 months, 12 months, 24 months). At each interval, we obtained radiographs and patient outcome measures, including SF-36 Bodily Pain Score, visual analog scale pain rating, and Oswestry Disability Index. The primary outcome was fusion results at 12 and 24 months; the secondary outcomes were pain, disability, function/quality of life, and satisfaction. One-level PLIFs were performed in 65 patients, and 2-level PLIFs in 24 patients. Flexion-extension radiographs at 12 and 24 months revealed a 98% fusion rate. Of the 72 patients who reached the 12-month follow-up, 86% reported decreased pain and disability as measured with the Oswestry Disability Index. Decreased pain as measured with the SF-36 Bodily Pain Score was reported by 74% of patients who reached the 12-month follow-up. The graft-related complication rate among all patients who underwent PLIF was 1.61%. When performed with machined allograft spacers and posterior pedicle fixation, PLIF is a safe and effective surgical treatment for low back pain caused by degenerative disc disease. The patients in this clinical series had outcomes equal or superior to the outcomes in previous series.

摘要

在过去60年里,人们对腰椎后路椎间融合术(PLIF)的临床益处及并发症进行了研究。近年来,脊柱外科医生可选择使用加工好的同种异体骨间隔器和后路椎弓根固定术,通过PLIF来治疗因椎间盘退变疾病引起的腰痛。本临床系列研究的目的是评估使用加工好的PLIF同种异体骨间隔器和后路椎弓根固定术治疗椎间盘退变疾病的临床益处,包括融合率和患者预后,并将这些结果与之前使用自体骨和金属椎间融合装置的研究结果进行比较。研究结果还与横突融合术的研究结果进行了对比。这项前瞻性、非随机临床系列研究在美国10家医疗中心开展。2000年1月至2003年4月期间,89例患者(55例男性,34例女性)接受了尺寸预先确定的加工好的同种异体骨间隔器和后路椎弓根固定术的PLIF治疗。他们的预后与文献中描述的既往系列研究结果进行了比较。所有患者均经历了至少6个月对非手术治疗无反应的腰痛。在手术前、手术后以及4次随访(6周、6个月、12个月、24个月)时进行了体格检查。在每个时间间隔,我们获取了X线片和患者预后指标,包括SF-36身体疼痛评分、视觉模拟量表疼痛评分和Oswestry功能障碍指数。主要预后指标是12个月和24个月时的融合结果;次要预后指标是疼痛、功能障碍、功能/生活质量和满意度。65例患者接受了单节段PLIF,24例患者接受了双节段PLIF。12个月和24个月时的屈伸位X线片显示融合率为98%。在72例完成12个月随访的患者中,86%的患者报告Oswestry功能障碍指数测量显示疼痛和功能障碍减轻。在完成12个月随访的患者中,74%的患者报告SF-36身体疼痛评分测量显示疼痛减轻。所有接受PLIF的患者中,与移植物相关的并发症发生率为1.61%。当采用加工好的同种异体骨间隔器和后路椎弓根固定术进行PLIF时,它是治疗椎间盘退变疾病引起的腰痛的一种安全有效的手术方法。本临床系列研究中的患者预后与既往系列研究结果相当或更优。

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