Huang Wei-Min, Yu Xing-Ming, Xu Xiao-Duo, Song Ruo-Xian, Yu Li-Li, Yu Xiu-Chun
Department of Orthopaedics, General Hospital of Jinan Military Commanding Region, Jinan, China.
Postgraduate Training Base in General Hospital of Jinan Military Command, Liaoning Medical University, Jinzhou, China.
Orthop Surg. 2017 May;9(2):198-205. doi: 10.1111/os.12328. Epub 2017 May 24.
To investigate the clinical feasibility and validity of interspinous fastener (ISF) for lumbar degenerative diseases.
From October 2013 to March 2014, a total of 46 patients suffering from lumbar degenerative diseases underwent posterior lumbar interbody fusion (PLIF) randomly augmented by ISF or pedicle screws. The clinical outcome was primarily measured by Oswestry Disability Index (ODI) score. The minimal clinical important difference (MCID) was defined as an eight-point decrease in ODI. The second clinical outcome measurement was Japanese Orthopedic Association (JOA) score. Interbody fusion rates were evaluated by lumbar plain radiograph and computed tomography (CT) scan. Complications were also compared between groups. Statistical analyses were performed by SPSS version 13.0. Sample size calculation was performed before the study. The type I error α was set at 0.05 and the type II error β at 0.1. Based on these assumptions and adding 10% for possible drop-outs, sample size calculations indicated that a total of 46 patients were required for the study. Parametric data was compared by independent t-test and categorical variables were compared using χ -tests or Fisher exact tests depending on the sample size. A P-value of less than 0.05 was considered significantly statistically different. Fleiss kappa coefficients were calculated for intra-observer and inter-observer reliability.
A total of 43 patients completed the follow-up, with 22 cases in the ISF group and 21 patients in the pedicle screws group, respectively. Less intraoperative blood loss and shorter operation time were observed in the ISF group. The mean ODI significantly declined in both groups, with the ISF group's decreasing from preoperative 43.3 ± 8.2 to 21.4 ± 3.5 at 24-month follow-up and the pedicle screws group's decreasing from preoperative 42.9 ± 7.9 to 22.5 ±3.8 at 24-month follow-up, respectively. The ODI changes between groups had no statistical difference (P > 0.05). Of the 43 patients, 33 patients achieved an MCID. The bone fusion rate was 77.3% according to X-rays and 68.2% according to CT scans in the ISF group, and 81.0% according to X-rays and 76.2% according to CT scans in the pedicle screws group at the final follow-up. The intra-observer and inter-observer reliability assessed by the kappa value were 0.93 and 0.89, respectively. One patient in the pedicle screws group demonstrated screw loosening at the 6-month follow-up but was asymptomatic. One patient with spondylolisthesis in the ISF group demonstrated cage subsidence during the follow-up but also without related symptoms.
The less invasive ISF combined with PLIF provided comparable clinical outcome and a similar bone fusion rate to pedicle screws. The ISF could potentially serve as a new alternative for lumbar degenerative diseases.
探讨棘突间内固定器（ISF）治疗腰椎退变性疾病的临床可行性及有效性。
2013年10月至2014年3月，共46例腰椎退变性疾病患者接受了后路腰椎椎间融合术（PLIF），随机采用ISF或椎弓根螺钉进行强化。临床疗效主要通过Oswestry功能障碍指数（ODI）评分来衡量。最小临床重要差异（MCID）定义为ODI下降8分。第二项临床疗效指标为日本骨科学会（JOA）评分。通过腰椎X线平片和计算机断层扫描（CT）评估椎间融合率。同时比较两组的并发症情况。采用SPSS 13.0版进行统计分析。在研究前进行样本量计算。I类错误α设定为0.05，II类错误β设定为0.1。基于这些假设并考虑10%的可能失访率，样本量计算表明该研究共需要46例患者。参数数据采用独立t检验进行比较，分类变量根据样本量使用χ²检验或Fisher精确检验进行比较。P值小于0.05被认为具有显著统计学差异。计算Fleiss kappa系数以评估观察者内和观察者间的可靠性。
共43例患者完成随访，ISF组22例，椎弓根螺钉组21例。ISF组术中出血量更少，手术时间更短。两组患者的平均ODI均显著下降，ISF组在24个月随访时从术前的43.3±8.2降至21.4±3.5，椎弓根螺钉组在24个月随访时从术前的42.9±7.9降至22.5±3.8。两组间ODI变化无统计学差异（P>0.05）。43例患者中，33例达到MCID。在末次随访时，ISF组根据X线显示的骨融合率为77.3%，根据CT扫描为68.2%；椎弓根螺钉组根据X线显示的骨融合率为81.0%，根据CT扫描为76.2%。通过kappa值评估的观察者内和观察者间可靠性分别为0.93和0.89。椎弓根螺钉组1例患者在6个月随访时出现螺钉松动，但无症状。ISF组1例腰椎滑脱患者在随访期间出现椎间融合器下沉，但也无相关症状。
微创的ISF联合PLIF提供了与椎弓根螺钉相当的临床疗效和相似的骨融合率。ISF有可能成为治疗腰椎退变性疾病的一种新选择。
