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ProDisc-L学习曲线:44例连续病例的24个月临床和影像学结果。

ProDisc-L learning curve: 24-Month clinical and radiographic outcomes in 44 consecutive cases.

作者信息

Low Jeffrey B, Du Jerry, Zhang Kai, Yue James J

机构信息

Yale Orthopedics/Spine Service, New Haven, CT.

出版信息

Int J Spine Surg. 2012 Dec 1;6:184-9. doi: 10.1016/j.ijsp.2012.07.001. eCollection 2012.

DOI:10.1016/j.ijsp.2012.07.001
PMID:25694889
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4300900/
Abstract

BACKGROUND

Total disc replacement (TDR) promises preservation of spine biomechanics in the treatment of degenerative disc disease but requires more careful device placement than tradition fusion and potentially has a more challenging learning curve.

METHODS

A cohort of 44 consecutive patients had 1-level lumbar disc replacement surgery at a single institution by a single surgeon. Patients were followed up clinically and radiographically for 24 months. Patients were divided into 2 groups of 22 sequential cases each. Clinically, preoperative and postoperative Oswestry Disability Index, visual analog scale, Short Form 12 (SF-12) Mental and Physical Components, and postoperative satisfaction were measured. Radiographically, preoperative and postoperative range of motion (ROM) dimensions, prosthesis deviation from the midline, and disc height were measured. TDR-related complications were noted. Logarithmic curve-fit regression analysis was used to assess the learning curve.

RESULTS

Operative time decreased as cases progressed, with an asymptote after 22 cases. The operative time for the later group was significantly lower (P < .0005), but hospital stay was significantly longer (P = .03). There was no significant difference in amount of blood loss (P = .10) or prosthesis midline deviation (P = .86). Clinically, there was no significant difference in postoperative scores between groups in Oswestry Disability Index (P = .63), visual analog scale (P = .45), SF-12 Mental Component (P = .66), SF-12 Physical Component (P = .75), or postoperative satisfaction (P = .92) at 24 months. Radiographically, there was no significant difference in improvement between groups in ROM (P = .67) or disc height (P = .87 for anterior and P = .13 for posterior) at 24 months. For both groups, there was significant improvement for all clinical outcomes and disc height over preoperative values. One patient in the later group had device failure with subluxation of the polyethylene, which required revision.

CONCLUSIONS/LEVEL OF EVIDENCE: Early experience can quickly reduce operative time but does not affect clinical outcomes or ROM significantly (level IV case series).

CLINICAL RELEVANCE

Lumbar TDR is a rapidly learnable technique in treatment of degenerative disc disease.

摘要

背景

全椎间盘置换术(TDR)有望在治疗退行性椎间盘疾病时保留脊柱生物力学,但与传统融合术相比,其器械放置需要更谨慎,且学习曲线可能更具挑战性。

方法

一组连续44例患者在单一机构由同一位外科医生进行了单节段腰椎间盘置换手术。对患者进行了24个月的临床和影像学随访。患者被分为两组,每组22例连续病例。临床上,测量术前和术后的奥斯威斯利功能障碍指数、视觉模拟评分、简短健康调查问卷12项(SF - 12)心理和生理成分以及术后满意度。影像学上,测量术前和术后的活动范围(ROM)尺寸、假体偏离中线的程度以及椎间盘高度。记录与TDR相关的并发症。采用对数曲线拟合回归分析评估学习曲线。

结果

随着病例数增加,手术时间减少,22例后趋于平稳。后一组的手术时间显著更低(P <.0005),但住院时间显著更长(P =.03)。失血量(P =.10)或假体中线偏差(P =.86)无显著差异。临床上,24个月时两组在奥斯威斯利功能障碍指数(P =.63)、视觉模拟评分(P =.45)、SF - 12心理成分(P =.66)、SF - 12生理成分(P =.75)或术后满意度(P =.92)方面的术后评分无显著差异。影像学上,24个月时两组在ROM改善(P =.67)或椎间盘高度(前部P =.87,后部P =.13)方面无显著差异。两组的所有临床结局和椎间盘高度均较术前值有显著改善。后一组中有1例患者出现器械故障,聚乙烯半脱位,需要翻修。

结论/证据水平:早期经验可迅速缩短手术时间,但对临床结局或ROM无显著影响(IV级病例系列)。

临床意义

腰椎TDR是治疗退行性椎间盘疾病的一种可快速掌握的技术。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b48d/4300900/7978cc92582c/IJSS-6-2012-07-001-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b48d/4300900/6013e0190b3b/IJSS-6-2012-07-001-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b48d/4300900/f20fa2fad92c/IJSS-6-2012-07-001-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b48d/4300900/7978cc92582c/IJSS-6-2012-07-001-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b48d/4300900/6013e0190b3b/IJSS-6-2012-07-001-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b48d/4300900/f20fa2fad92c/IJSS-6-2012-07-001-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b48d/4300900/7978cc92582c/IJSS-6-2012-07-001-g003.jpg

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