Surgical Treatment of Patients with Sacroiliac Joint Syndrome: Comparative Study of Two Implants.

Theresa Splitt, Robert Pflugmacher, Osama Soliman, Hany Mohamed Abd Allah, Rudolf Hering, Adnan Kasapovic, Philip Rössler, Ernst M W Koch, Rahel Bornemann
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Abstract

The treatment of patients with ISJ dysfunction is difficult due to the multifactorial causes of pain and various problems in clarification. Treatment includes physical therapy, corticosteroids, prolotherapy, radiofrequency denervation and sacroiliac joint fusion. A new option for the surgical treatment of ISG dysfunction is the Torpedo implant system. For a safe fusion, only 2 implants are needed, which are available in lengths of 30-50 mm. The new implant system has been tested in pilot studies for efficacy and biocompatibility with good results. For further documentation for the Torpedo implant system, a comparative study against the iFuse system was carried out.Two different implants were used: Group 1: Deltacor Torpedo, Group 2: iFuse implants (Si-Bone). The data generated during admission and subsequent check-ups (VAS, ODI, opioid use) were entered into an evaluation file set up for this purpose. Follow-up appointments were set at 1 month, 3, 6 and 12 months postoperatively.The data of 65 patients were evaluated comparatively. In all comparisons, only very small effect sizes were found with regard to the differences in the decrease in pain intensities, so that equivalent effectiveness of the two methods could initially be postulated from a clinical point of view. Most patients in both groups reported taking opioids to treat pain before surgery. According to the decrease in pain intensity, opioid treatment could be discontinued in some patients after the operation. After 12 months, the number of patients treated with opioids decreases to 23% in group 1 and to 17% in group 2. The success of the fusions with the two methods can also be proven by image documentation, from which the position of the implants can also be clearly recognised. In no case was there any loosening.Overall, the evaluation of this study allows the conclusion that both implant systems can be successfully used for the treatment of patients with ISJ syndrome. The present results should be confirmed in further comparative studies with the proposed evaluation methods.

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骶髂关节综合征的手术治疗:两种植入物的比较研究。
ISJ功能障碍患者的治疗是困难的,由于疼痛的多因素原因和各种问题的澄清。治疗包括物理治疗、皮质类固醇、前驱治疗、射频去神经支配和骶髂关节融合术。手术治疗ISG功能障碍的新选择是鱼雷植入系统。为了安全的融合,只需要2个种植体,长度为30-50毫米。新的植入系统已经在中试研究中进行了有效性和生物相容性测试,并取得了良好的结果。为了进一步记录鱼雷植入系统,对iFuse系统进行了比较研究。使用两种不同的植入物:1组:Deltacor Torpedo, 2组:iFuse植入物(Si-Bone)。入院期间和随后的检查(VAS, ODI,阿片类药物使用)产生的数据被输入为此目的建立的评估文件。随访时间分别为术后1个月、3个月、6个月和12个月。对65例患者的资料进行比较评价。在所有的比较中,只有非常小的效应大小被发现关于疼痛强度减少的差异,因此,从临床的角度来看,这两种方法的等效效果可以初步假设。两组中的大多数患者都报告在手术前服用阿片类药物来治疗疼痛。根据疼痛强度的减轻情况,部分患者术后可停用阿片类药物治疗。12个月后,阿片类药物治疗的患者数量在第1组减少到23%,在第2组减少到17%。两种方法融合的成功也可以通过图像文件来证明,从图像文件中也可以清楚地识别植入物的位置。在任何情况下都没有任何松动。总的来说,本研究的评估得出结论,两种植入系统都可以成功地用于ISJ综合征患者的治疗。本研究结果有待与所提出的评价方法进行进一步的比较研究。
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