Hannibal Matthew, Thomas Derek J, Low Jeffrey, Hsu Ken Y, Zucherman James
Greater Pittsburgh Orthopaedic Associates, Pittsburgh, PA, USA.
Spine (Phila Pa 1976). 2007 Oct 1;32(21):2322-6. doi: 10.1097/BRS.0b013e3181557c06.
This is a retrospective analysis of data that was collected prospectively from 2 concurrent FDA IDE lumbar arthroplasty clinical trials performed at a single center.
To determine if there is a clinical difference between the 1-level ProDisc patients versus the 2-level ProDisc patients at a minimum of 2 years of follow-up.
Marnay's work with ProDisc I prompted the U.S. Clinical Trials of the ProDisc II under the direction of the FDA. Disc replacement surgery in the United States has shown promising results for all types of prostheses up to 6 months. Marnay and colleagues showed that their results at 10 years were still promising, and they saw no significant difference between 1-level and multilevel disc replacements. The findings of Ipsen and colleagues suggest that multilevel arthroplasty cases may be less successful than disc replacement at a single level.
Patients were part of the FDA clinical trial for the Prodisc II versus circumferential fusion study at a single institution. We identified 27 patients who received ProDisc at 1 level and 32 who received it at 2 levels with at least a 2-year follow-up, for a total of 59 patients. Unpaired t tests were performed on the mean results of Visual Analog Scale, Oswestry Disability Index, SF-36 Healthy Survey Physical Component Summary, and satisfaction using 10-cm line visual scale scores to determine a clinical difference if any between the 2 populations.
While patients receiving ProDisc at 2 levels scored marginally lower in all evaluation indexes, score differences in each category were also found to hold no statistical significance.
This study was unable to identify a statistically significant difference in outcome between 1- and 2-level ProDisc arthroplasty patients in a cohort from a single center. The equality of clinical effectiveness between 1- and 2-level ProDisc has yet to be determined.
这是一项对前瞻性收集的数据进行的回顾性分析，这些数据来自于在单一中心进行的两项同时开展的美国食品药品监督管理局（FDA）器械研究豁免（IDE）腰椎置换临床试验。
确定在至少2年的随访期内，单节段ProDisc患者与双节段ProDisc患者之间是否存在临床差异。
Marnay对ProDisc I的研究促使美国在FDA的指导下开展了ProDisc II的临床试验。在美国，椎间盘置换手术在6个月内对所有类型的假体均显示出了有前景的结果。Marnay及其同事表明，他们10年时的结果仍然很有前景，并且他们发现单节段和多节段椎间盘置换之间没有显著差异。Ipsen及其同事的研究结果表明，多节段置换病例可能不如单节段椎间盘置换成功。
患者参与了在单一机构进行的Prodisc II与环形融合研究的FDA临床试验。我们确定了27名单节段接受ProDisc的患者和32名双节段接受ProDisc的患者，他们均有至少2年的随访期，共计59名患者。对视觉模拟量表、Oswestry功能障碍指数、SF - 36健康调查身体成分总结的平均结果以及使用10厘米直线视觉量表评分的满意度进行了独立样本t检验，以确定这两组人群之间是否存在临床差异。
虽然双节段接受ProDisc的患者在所有评估指标上的得分略低，但各类别中的得分差异也均无统计学意义。
本研究未能在来自单一中心的队列中发现单节段和双节段ProDisc置换患者在结局上存在统计学显著差异。单节段和双节段ProDisc在临床有效性方面的等同性尚未确定。
