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10 年平均随访后腰椎全椎间盘置换术后患者报告的结局和翻修率。

Patient-reported Outcomes and Revision Rates at a Mean Follow-up of 10 Years After Lumbar Total Disc Replacement.

机构信息

Center for Spine Surgery & Research, Region of Southern Denmark, Middelfart, Denmark.

Department of Clinical Research and Institute of Regional Health Research, University of Southern Denmark, Odense C, Denmark.

出版信息

Spine (Phila Pa 1976). 2017 Nov 1;42(21):1657-1663. doi: 10.1097/BRS.0000000000002174.

Abstract

STUDY DESIGN

Prospective observational cohort study.

OBJECTIVE

The aim of this study was to determine the long-term clinical results and prosthesis survival in patients treated with lumbar total disc replacement (TDR).

SUMMARY OF BACKGROUND DATA

Fusion has become the current standard surgical treatment for lumbar degenerative disease. TDR is an alternative treatment that seeks to avoid fusion-related adverse events, specifically adjacent segment disease.

METHODS

Sixty-eight consecutive patients treated with TDR from 2003 to 2008 were invited to follow-up and complete a Visual Analog Scale (VAS) for back and leg pain, the Dallas Pain Questionnaire (DPQ), and the Short Form-36. These surveys were also administered to the subjects before their index TDRs. Data on reoperation were collected from the patients' medical records.

RESULTS

Fifty-seven (84%) patients were available for follow-up at a mean 10.6 years post-operatively (range 8.1-12.6 years). There was a significant improvement from preop to latest follow-up in VAS (6.8 vs. 3.2, P < 0.000) and DPQ (63.2 vs. 45.6, P = 0.000) in the entire cohort. Nineteen patients (33%) had a revision fusion surgery after their index TDR. Patients who had revision surgery had statistically significant worse outcome scores at last follow-up than patients who had no revision. Thirty patients (52.6%) would choose the same treatment again if they were faced with the same problem.

CONCLUSION

This study demonstrated significant improvement in long-term clinical outcomes, similar to previously published studies, and two-thirds of the discus prostheses were still functioning at follow-up. However, there is still a lack of well-designed long-term studies, thus requiring further investigation.

LEVEL OF EVIDENCE

摘要

研究设计

前瞻性观察队列研究。

目的

本研究旨在确定接受腰椎全椎间盘置换术(TDR)治疗的患者的长期临床结果和假体生存率。

背景资料概要

融合已成为治疗腰椎退行性疾病的当前标准手术治疗方法。TDR 是一种替代治疗方法,旨在避免与融合相关的不良事件,特别是相邻节段疾病。

方法

邀请 2003 年至 2008 年间接受 TDR 治疗的 68 例连续患者进行随访,并完成腰痛和腿痛视觉模拟量表(VAS)、达拉斯疼痛问卷(DPQ)和简短形式-36。这些调查也在患者的 TDR 指数之前对受试者进行了评估。从患者的病历中收集了再次手术的数据。

结果

57 名(84%)患者在术后平均 10.6 年(8.1-12.6 年)时可进行随访。整个队列的 VAS(6.8 对 3.2,P<0.000)和 DPQ(63.2 对 45.6,P=0.000)均有显著改善。19 例(33%)患者在其 TDR 指数后进行了修订融合手术。接受修订手术的患者在最后一次随访时的结果评分明显低于未接受修订手术的患者。30 名患者(52.6%)如果面临同样的问题,会再次选择相同的治疗方法。

结论

本研究表明,长期临床结果显著改善,与先前发表的研究相似,三分之二的椎间盘假体在随访时仍在发挥作用。然而,仍缺乏精心设计的长期研究,因此需要进一步研究。

证据水平

3 级。

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