Kucharzyk Donald, Colle Kyle, Boone Christopher, Araghi Ali
DK Orthopedics, Crown Point, IN, USA.
Regional Brain and Spine, Cape Girardeau, MO, USA.
Int J Spine Surg. 2022 Feb;16(1):168-175. doi: 10.14444/8185. Epub 2022 Feb 25.
This report documents 1-year results of 250 patients enrolled in a prospective, multicenter study of a minimally invasive (MI) sacroiliac joint fusion (SIJF) system that uses decortication, graft placement, and joint fixation.
The cohort includes all patients enrolled in the EVoluSIon (EVSI) clinical study who had MI SIJF surgery and completed 1-year follow-up. Average age at baseline was 60.5 years, and 70.8% were female. Sacroiliac (SI) joint-related pain duration was ≥2 years in 56% of patients. Visual analog scale (VAS) SI joint pain, Oswestry Disability Index (ODI), quality of life, and opioid use were assessed preoperatively and at 1 year.
At 1 year, the mean VAS pain demonstrated a significant reduction of more than 43 points, from 76.4 at baseline to 33.0 ( < 0.0001), with 72.2% of patients attaining the minimal clinically important difference (MCID, ≥20-point improvement). Mean ODI scores also significantly improved from 54.4 at baseline to 30.5 at 1 year ( < 0.0001), with 62.5% of patients achieving the MCID (≥15-point improvement). Prior to surgery, 62.7% (126/201) of patients were taking opioids or other narcotics, but by 1 year postsurgery, only 26.9% (54/201) of patients reported using these medications, representing a significant 57.1% decrease in narcotic/opioid use ( < 0.0001). Fusion of the SI joint was seen in 68.7% of patients. Few procedural complications were reported. In all, there were 8 (8/250) serious procedure-related events, including 1 device malposition observed on the day of surgery that required replacing the superior screw with a shorter screw.
Analysis of patients treated with MI SIJF in the EVSI study demonstrated that the procedure can be performed safely and results in significant improvements in pain, quality of life, and opioid use at 1 year as well as causing fusion in the majority of patients.
MI SIJF differs from most procedures currently being performed in that it applies true orthopedic principles with decorticating, bone grafting, fusion, and placement of implants perpendicular to the joint for greatest stability. The 12-month data show improvement in functionality, reduction in pain, and, most notably, a reduction in narcotic usage, which is important considering the ongoing opioid epidemic.
本报告记录了250例患者参与一项前瞻性、多中心研究的1年结果，该研究针对一种采用去皮质、植骨和关节固定的微创（MI）骶髂关节融合（SIJF）系统。
该队列包括所有参与EVoluSIon（EVSI）临床研究且接受了MI SIJF手术并完成1年随访的患者。基线时的平均年龄为60.5岁，70.8%为女性。56%的患者骶髂（SI）关节相关疼痛持续时间≥2年。术前及1年时评估视觉模拟量表（VAS）SI关节疼痛、Oswestry功能障碍指数（ODI）、生活质量和阿片类药物使用情况。
在1年时，平均VAS疼痛显著降低超过43分，从基线时的76.4降至33.0（<0.0001），72.2%的患者达到最小临床重要差异（MCID，改善≥20分）。平均ODI评分也从基线时的54.4显著改善至1年时的30.5（<0.0001），62.5%的患者达到MCID（改善≥15分）。手术前，62.7%（126/201）的患者正在服用阿片类药物或其他麻醉剂，但术后1年时，只有26.9%（54/201）的患者报告使用这些药物，麻醉剂/阿片类药物使用显著减少57.1%（<0.0001）。68.7%的患者出现SI关节融合。报告的手术并发症很少。总共发生了8起（8/250）与手术相关的严重事件，包括1例在手术当天观察到的器械位置不当，需要用较短的螺钉更换上位螺钉。
对EVSI研究中接受MI SIJF治疗的患者进行分析表明，该手术可以安全进行，并且在1年时能显著改善疼痛、生活质量和阿片类药物使用情况，同时使大多数患者实现融合。
MI SIJF与目前正在进行的大多数手术不同，它应用了真正的骨科原则，包括去皮质、植骨、融合以及将植入物垂直于关节放置以实现最大稳定性。12个月的数据显示功能有所改善、疼痛减轻，最显著的是麻醉剂使用减少，考虑到持续的阿片类药物流行，这一点很重要。
