Department of Orthopedic and Trauma Surgery, University Hospital Bonn, Bonn, Germany.
Department of Orthopaedic and Spine Surgery, Wadi al Neel Military, Hospital, Cairo, Egypt.
Technol Health Care. 2022;30(5):1139-1145. doi: 10.3233/THC-213348.
Sacroiliac joint (SIJ) painful dysfunction is a common source of low back pain (LBP). Several surgical treatment options for SIJ fusion were described. A promising treatment option with demonstrated clinical improvement is the minimally-invasive SIJ fusion.
The aim of this case study was to document the effectiveness and safety of the new SIJ system (Torpedo®) over a period of 6 months after the minimally invasive implantation.
Patients with failed conservative treatment of painful SIJ dysfunction were enrolled successively in two centers. The Diagnosis was made by positive response to SIJ-injection with local anesthetic and at least by two positive SIJ provocation tests. The Torpedo® Implant system was used for the implantation. This workpiece made of titanium alloy is characterized by a helical profile geometry (CST: chronical spinal turn) with a hydrophilic surface. The evaluated endpoints LBP and grade of disability were assessed using a 0-10 numerical rating scale (NRS), and Oswestry Disability Index (ODI) preoperatively and at one, three and six months postoperatively.
15 patients (10 female, 5 male; mean age 59 ± 13 years) were operated on one after the other. The pain intensity decreased in all 15 patients. After 6 months, a decrease in the median values of 70% (quartiles 1-3: 65-79%) was calculated. The median values of the Oswestry Disability Index after 6 months were 62% (quartiles 1-3: 53-67) lower than before the operation. Before surgery, 13 patients (87%) were taking opioids for pain management. Six months after the operation, opioids were only needed by 3 patients (20%). Implant malpositioning was not detected on plain radiograph. No surgical site infections or perioperative complications occurred.
The clinical improvement in early follow up and the absence of surgery related complications demonstrate a high grade of device-related safety and effectiveness of the treatment with a novel minimally-invasive SIJ fusion system.
骶髂关节（SIJ）疼痛功能障碍是腰痛（LBP）的常见病因。已经描述了几种用于 SIJ 融合的手术治疗选择。一种有前途的治疗选择是微创 SIJ 融合，已证明其具有临床改善效果。
本病例研究的目的是记录新型 SIJ 系统（Torpedo®）在微创植入后 6 个月内的有效性和安全性。
在两个中心连续招募对疼痛性 SIJ 功能障碍的保守治疗失败的患者。通过对局部麻醉的 SIJ 注射有阳性反应，以及至少有两个阳性 SIJ 激发试验来做出诊断。使用 Torpedo®植入系统进行植入。该工具由钛合金制成，其特点是具有螺旋状轮廓几何形状（CST：慢性脊柱旋转）和亲水表面。使用 0-10 数字评分量表（NRS）术前和术后 1、3 和 6 个月评估腰痛和残疾程度这两个评估终点，并使用 Oswestry 残疾指数（ODI）进行评估。
15 名患者（10 名女性，5 名男性；平均年龄 59±13 岁）逐个进行了手术。所有 15 名患者的疼痛强度均减轻。6 个月后，计算得出疼痛强度中位数降低了 70%（四分位间距 1-3：65-79%）。6 个月后，Oswestry 残疾指数的中位数为 62%（四分位间距 1-3：53-67），低于术前。手术前，13 名患者（87%）服用阿片类药物来缓解疼痛。术后 6 个月，仅 3 名患者（20%）需要服用阿片类药物。在普通 X 光片上未发现植入物错位。没有发生手术部位感染或围手术期并发症。
早期随访时的临床改善以及没有与手术相关的并发症表明，新型微创 SIJ 融合系统具有高度的设备相关安全性和有效性。
