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后路骶髂融合术:一项回顾性单中心研究。

Posterior Sacroiliac Fusion Surgery: A Retrospective Single Center Study.

机构信息

Louisiana State University School of Medicine, Shreveport, LA.

School of Medicine, Louisiana State University Health Sciences Center at Shreveport, Shreveport, LA.

出版信息

Pain Physician. 2024 Jul;27(5):321-331.

Abstract

BACKGROUND

Chronic sacroiliitis has variable etiologies with numerous treatments of varying efficacy. In recent years, a novel posterior approach utilizing bone matrix has been developed although to date, there is limited data in the literature regarding efficacy and safety through this approach. Benefits described include reduced adverse outcomes and quicker recovery when compared to the lateral approach.

OBJECTIVE

The present investigation focused on sacroiliac joint fusion through the posterior approach and outcomes including disability, pain, and use of analgesics post-surgery.

STUDY DESIGN

This retrospective, single-center study was conducted evaluating safety and efficacy of sacroiliac fusion allograft implants (LinQ Implant System from PainTEQ; PsiF System from Omnia Medical).

METHODS

A total of 72 posterior approach sacroiliac joint fusions were performed. Fifty-three individuals were enrolled and followed at LSU Health Shreveport as the sole investigational site between August 2020 and June 2024. Selected participant age ranged between 28 and 79 years, with a mean age of 53.4 years. The LinQ Implant System was the primary surgical hardware selected for implantation (83.0%), with the PsiF System chosen in the remaining cases.

OUTCOME MEASURES

VAS Scores, disability changes, adverse outcomes, and analgesic use were compared after sacroiliac joint fusion via the posterior approach.

RESULTS

Mean VAS Scores for SIJ Pain Intensity significantly decreased by 3.6 cm from a baseline score of 9.5 cm by the Specified End (June 1st, 2024). In this regard, 65.4% of patients experienced a 20% or greater improvement in pain, 38.5% of patients experienced a 50% or greater improvement in pain, and 26.9% of patients experienced a 70% or greater improvement in pain.  Zero (0) procedure-related adverse events nor intra- or post-operative complications occurred throughout the duration of the investigation.

LIMITATIONS

Retrospective nature of the study without a control group. Fifty-four percent (39 of 72) completed minimum one year follow up. Further, the withdrawal rate was 26%.

CONCLUSION

The results of the present investigation demonstrated effective outcomes with minimal adverse effects and improvements in disability over a three-year period in the largest single center study to date involving posterior approach sacroiliac joint fusion.

摘要

背景

慢性骶髂关节炎的病因多种多样,治疗方法也多种多样,疗效各异。近年来,一种新的后路利用骨基质的方法已经开发出来,尽管迄今为止,通过这种方法的疗效和安全性数据有限。描述的好处包括与侧路相比,不良结果减少和恢复更快。

目的

本研究集中于后路骶髂关节融合,包括术后残疾、疼痛和镇痛药的使用。

研究设计

这是一项回顾性、单中心研究,评估后路骶髂关节融合同种异体移植物植入物的安全性和疗效(来自 PainTEQ 的 LinQ 植入系统;来自 Omnia Medical 的 PsiF 系统)。

方法

共进行了 72 例后路骶髂关节融合术。53 名患者在 LSU Health Shreveport 作为唯一的研究地点入组并随访,时间为 2020 年 8 月至 2024 年 6 月。选择的患者年龄在 28 至 79 岁之间,平均年龄为 53.4 岁。LinQ 植入系统是主要的手术硬件选择(83.0%),其余情况下选择 PsiF 系统。

结果测量

后路骶髂关节融合后,通过视觉模拟评分(VAS)、残疾变化、不良结果和镇痛药使用进行比较。

结果

骶髂关节疼痛强度的平均 VAS 评分从基线时的 9.5cm 显著下降 3.6cm,到特定终点(2024 年 6 月 1 日)。在这方面,65.4%的患者疼痛改善 20%或以上,38.5%的患者疼痛改善 50%或以上,26.9%的患者疼痛改善 70%或以上。整个研究过程中没有发生与手术相关的不良事件或围手术期并发症。

局限性

研究为回顾性,没有对照组。54%(39/72)完成了至少一年的随访。此外,退出率为 26%。

结论

本研究结果表明,在后路骶髂关节融合术最大的单中心研究中,在三年的时间内,通过最小的不良影响和残疾改善,获得了有效的结果。

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