Bornemann Rahel, Roessler Philip P, Strauss Andreas C, Sander Kirsten, Rommelspacher Yorck, Wirtz Dieter C, Pflugmacher Robert, Frey Sönke P
Technol Health Care. 2017;25(2):319-325. doi: 10.3233/THC-161272.
Sacroiliac joint (SIJ) syndrome can cause various symptoms and may also be one reason for persistent low back pain, especially in patients with prior spinal fusions. If conservative treatments fail to improve symptoms, arthrodesis surgery can be considered. Minimally invasive approaches have emerged recently providing a good alternative to conventional methods. A novel triangular implant system (iFuse) can achieve an arthrodesis of the SIJ without the use of additional screws or bone material.
Aim of the present study was an evaluation of short-term safety and efficacy of the implant system.
Twenty-four patients were included in the study and treated with the iFuse system. In addition to demographic data, pain intensity (visual analogue scale) and functional impairment (Oswestry-disability index) were assessed prior to surgery and 1 month, 3 months, 6 months, 12 months and 24 months thereafter. During surgery and the follow up period all adverse events were documented and the correct implant position was controlled via plain radiographs.
VAS scores and ODI improved significantly directly after surgery from 84.3 ± 9.2 mm to 40.7 ± 9.2 mm and from 76.8 ± 9.2% to 40.7 ± 9.2 % (p < 0.001). The ODI improved further to 31 ± 5.4% after 24 months whereas the VAS improved until the 3 months examination and ten stayed constant between 27.7 mm and 26.5 mm to 27 ± 6.6 mm at 24 months. No adverse events, intraoperative complications, implant malpositioning or loosening could be recorded at any time.
The iFuse system is an effective and safe treatment for minimally invasive surgical arthrodesis of the SIJ. Pain and functional impairment can be significantly improved. However, in addition to this case series, further controlled studies are necessary, particularly in terms of a previous spinal fusion history.
骶髂关节（SIJ）综合征可引发多种症状，也可能是持续性腰痛的原因之一，尤其是在既往有脊柱融合手术史的患者中。若保守治疗无法改善症状，可考虑进行关节融合手术。近年来出现的微创方法为传统方法提供了良好的替代方案。一种新型三角形植入系统（iFuse）无需使用额外的螺钉或骨材料即可实现骶髂关节的融合。
本研究旨在评估该植入系统的短期安全性和有效性。
24例患者纳入本研究并接受iFuse系统治疗。除人口统计学数据外，在手术前以及术后1个月、3个月、6个月、12个月和24个月评估疼痛强度（视觉模拟量表）和功能障碍（Oswestry功能障碍指数）。在手术期间和随访期间记录所有不良事件，并通过X线平片检查植入物的正确位置。
术后VAS评分和ODI立即显著改善，从84.3±9.2mm降至40.7±9.2mm，从76.8±9.2%降至40.7±9.2%（p<0.001）。24个月后ODI进一步改善至31±5.4%，而VAS在3个月检查时有所改善，之后保持稳定，从27.7mm至26.5mm，24个月时为27±6.6mm。在任何时间均未记录到不良事件、术中并发症、植入物位置不当或松动情况。
iFuse系统是骶髂关节微创融合手术的一种有效且安全的治疗方法。疼痛和功能障碍可得到显著改善。然而，除了本病例系列外，还需要进一步的对照研究，特别是对于有既往脊柱融合手术史的患者。
