Welch William C, Cheng Boyle C, Awad Tariq E, Davis Reginald, Maxwell James H, Delamarter Rick, Wingate Jeffrey K, Sherman John, Macenski M Mason
University of Pittsburgh Medical Center-Health System, Presbyterian University Hospital, Pittsburgh, Pennsylvania 15213-2582, USA.
Neurosurg Focus. 2007 Dec 15;22(1):E8. doi: 10.3171/foc.2007.22.1.8.
In this study the authors present the preliminary clinical outcomes of dynamic stabilization with the Dynesys spinal system as part of a multicenter randomized prospective Food and Drug Administration (FDA) investigational device exemption (IDE) clinical trial.
This study included 101 patients from six IDE sites (no participants were omitted from the analysis) who underwent dynamic stabilization of the lumbar spine with the Dynesys construct. Patient participation was based on the presence of degenerative spondylolisthesis or retrolisthesis (Grade I), lateral or central spinal stenosis, and their physician's determination that the patient required decompression and instrumented fusion for one or two contiguous spinal levels between L-1 and S-1. Participants were evaluated preoperatively, postoperatively at 3 weeks, and then at 3-, 6-, and 12-month intervals. The 100-mm visual analog scale was used to score both lower-limb and back pain. Patient functioning was evaluated using the Oswestry Disability Index (ODI), and the participants' general health was assessed using the Short Form-12 questionnaire. Overall patient satisfaction was also reported. One hundred one patients (53 women and 48 men) with a mean age of 56.3 years (range 27-79 years) were included. The mean pain and function scores improved significantly from the baseline to 12-month follow-up evaluation, as follows: leg pain improved from 80.3 to 25.5, back pain from 54 to 29.4, and ODI score from 55.6 to 26.3%.
The early clinical outcomes of treatment with Dynesys are promising, with lessening of pain and disability found at follow-up review. Dynesys may be preferable to fusion for surgical treatment of degenerative spondylolisthesis and stenosis because it decreases back and leg pain while avoiding the relatively greater tissue destruction and the morbidity of donor site problems encountered in fusion. However, long-term follow-up care is still recommended.
在本研究中，作者介绍了使用Dynesys脊柱系统进行动态稳定治疗的初步临床结果，该研究是多中心随机前瞻性食品药品监督管理局（FDA）研究器械豁免（IDE）临床试验的一部分。
本研究纳入了来自6个IDE研究点的101例患者（分析中无参与者被遗漏），这些患者接受了Dynesys装置的腰椎动态稳定治疗。患者入选基于存在退行性椎体滑脱或椎体后滑（I级）、侧方或中央椎管狭窄，且其医生判定患者需要对L1至S1之间的一个或两个相邻脊柱节段进行减压和器械融合。在术前、术后3周以及术后3个月、6个月和12个月对参与者进行评估。使用100毫米视觉模拟量表对下肢疼痛和背痛进行评分。使用Oswestry功能障碍指数（ODI）评估患者功能，并使用简短健康调查问卷（SF-12）评估参与者的总体健康状况。还报告了患者的总体满意度。纳入了101例患者（53例女性和48例男性），平均年龄56.3岁（范围27 - 79岁）。从基线到12个月随访评估，疼痛和功能评分显著改善，如下：腿痛从80.3改善至25.5，背痛从54改善至29.4，ODI评分从55.6%改善至26.3%。
Dynesys治疗的早期临床结果令人鼓舞，随访复查发现疼痛和功能障碍减轻。对于退行性椎体滑脱和椎管狭窄的手术治疗，Dynesys可能比融合术更可取，因为它能减轻背痛和腿痛，同时避免融合术中相对更大的组织破坏和供区问题的并发症。然而，仍建议进行长期随访。
