PDF(Pubmed)
Abstract：
UNASSIGNED: An early-stage, multi-centre, prospective, randomised control trial with five-year follow-up was approved by Health Research Authority to compare the efficacy of a minimally invasive, laterally implanted interspinous fixation device (IFD) to open direct surgical decompression in treating lumbar spinal stenosis (LSS). Two-year results are presented.
UNASSIGNED: Forty-eight participants were randomly assigned to IFD or decompression. Primary study endpoints included changes from baseline at 8-weeks, 6, 12 and 24-months follow-ups for leg pain (visual analogue scale, VAS), back pain (VAS), disability (Oswestry Disability Index, ODI), LSS physical function (Zurich Claudication Questionnaire), distance walked in five minutes and number of repetitions of sitting-to-standing in one minute. Secondary study endpoints included patient and clinician global impression of change, adverse events, reoperations, operating parameters, and fusion rate.
UNASSIGNED: Both treatment groups demonstrated statistically significant improvements in mean leg pain, back pain, ODI disability, LSS physical function, walking distance and sitting-to-standing repetitions compared to baseline over 24 months. Mean reduction of ODI from baseline levels was between 35% and 56% for IFD (p<0.002), and 49% to 55% for decompression (p<0.001) for all follow-up time points. Mean reduction of IFD group leg pain was between 57% and 78% for all time points (p<0.001), with 72% to 94% of participants having at least 30% reduction of leg pain from 8-weeks through 24-months. Walking distance for the IFD group increased from 66% to 94% and sitting-to-standing repetitions increased from 44% to 64% for all follow-up time points. Blood loss was 88% less in the IFD group (p=0.024) and operating time parameters strongly favoured IFD compared to decompression (p<0.001). An 89% fusion rate was assessed in a subset of IFD participants. There were no intraoperative device issues or re-operations in the IFD group, and only one healed and non-symptomatic spinous process fracture observed within 24 months.
UNASSIGNED: Despite a low number of participants in the IFD group, the study demonstrated successful two-year safety and clinical outcomes for the IFD with significant operation-related advantages compared to surgical decompression.
UNASSIGNED: Forty-eight participants were randomly assigned to IFD or decompression. Primary study endpoints included changes from baseline at 8-weeks, 6, 12 and 24-months follow-ups for leg pain (visual analogue scale, VAS), back pain (VAS), disability (Oswestry Disability Index, ODI), LSS physical function (Zurich Claudication Questionnaire), distance walked in five minutes and number of repetitions of sitting-to-standing in one minute. Secondary study endpoints included patient and clinician global impression of change, adverse events, reoperations, operating parameters, and fusion rate.
UNASSIGNED: Both treatment groups demonstrated statistically significant improvements in mean leg pain, back pain, ODI disability, LSS physical function, walking distance and sitting-to-standing repetitions compared to baseline over 24 months. Mean reduction of ODI from baseline levels was between 35% and 56% for IFD (p<0.002), and 49% to 55% for decompression (p<0.001) for all follow-up time points. Mean reduction of IFD group leg pain was between 57% and 78% for all time points (p<0.001), with 72% to 94% of participants having at least 30% reduction of leg pain from 8-weeks through 24-months. Walking distance for the IFD group increased from 66% to 94% and sitting-to-standing repetitions increased from 44% to 64% for all follow-up time points. Blood loss was 88% less in the IFD group (p=0.024) and operating time parameters strongly favoured IFD compared to decompression (p<0.001). An 89% fusion rate was assessed in a subset of IFD participants. There were no intraoperative device issues or re-operations in the IFD group, and only one healed and non-symptomatic spinous process fracture observed within 24 months.
UNASSIGNED: Despite a low number of participants in the IFD group, the study demonstrated successful two-year safety and clinical outcomes for the IFD with significant operation-related advantages compared to surgical decompression.
摘要：
■早期阶段，多中心,prospective,5年随访的随机对照试验由卫生研究机构批准，用于比较微创的疗效，横向植入棘突间固定装置（IFD），以开放直接手术减压治疗腰椎管狭窄症（LSS）。提供了两年的结果。
■48名参与者被随机分配到IFD或减压。主要研究终点包括8周时基线的变化，6、12和24个月的腿部疼痛随访（视觉模拟评分，VAS),背痛（VAS），残疾(Oswestry残疾指数，ODI),LSS身体功能（苏黎世宣称问卷），五分钟内走了一段距离，一分钟内坐到站的重复次数。次要研究终点包括患者和临床医生对变化的整体印象，不良事件,重新操作,操作参数,和融合率。
■两个治疗组均显示出平均腿部疼痛的统计学显着改善，背痛,ODI残疾，LSS物理功能，24个月以上步行距离和坐立重复与基线的比较.对于IFD，ODI从基线水平的平均降低在35%到56%之间(p<0.002)，所有随访时间点的减压率为49%至55%(p<0.001)。所有时间点IFD组腿部疼痛的平均减少在57%和78%之间(p<0.001),72％至94％的参与者从8周到24个月的腿部疼痛减轻至少30％。在所有随访时间点，IFD组的步行距离从66％增加到94％，坐立重复次数从44％增加到64％。IFD组的失血减少了88%(p=0.024),与减压相比,手术时间参数强烈有利于IFD(p<0.001)。在IFD参与者的子集中评估了89%的融合率。IFD组没有术中器械问题或再次手术，在24个月内，仅观察到一例愈合且无症状的棘突骨折。
■尽管参加IFD组的人数很少，该研究证明,与手术减压相比,IFD在2年的安全性和临床结局方面具有显著的手术相关优势.
■48名参与者被随机分配到IFD或减压。主要研究终点包括8周时基线的变化，6、12和24个月的腿部疼痛随访（视觉模拟评分，VAS),背痛（VAS），残疾(Oswestry残疾指数，ODI),LSS身体功能（苏黎世宣称问卷），五分钟内走了一段距离，一分钟内坐到站的重复次数。次要研究终点包括患者和临床医生对变化的整体印象，不良事件,重新操作,操作参数,和融合率。
■两个治疗组均显示出平均腿部疼痛的统计学显着改善，背痛,ODI残疾，LSS物理功能，24个月以上步行距离和坐立重复与基线的比较.对于IFD，ODI从基线水平的平均降低在35%到56%之间(p<0.002)，所有随访时间点的减压率为49%至55%(p<0.001)。所有时间点IFD组腿部疼痛的平均减少在57%和78%之间(p<0.001),72％至94％的参与者从8周到24个月的腿部疼痛减轻至少30％。在所有随访时间点，IFD组的步行距离从66％增加到94％，坐立重复次数从44％增加到64％。IFD组的失血减少了88%(p=0.024),与减压相比,手术时间参数强烈有利于IFD(p<0.001)。在IFD参与者的子集中评估了89%的融合率。IFD组没有术中器械问题或再次手术，在24个月内，仅观察到一例愈合且无症状的棘突骨折。
■尽管参加IFD组的人数很少，该研究证明,与手术减压相比,IFD在2年的安全性和临床结局方面具有显著的手术相关优势.
