Safety and initial effectiveness of minimally invasive sacroiliac joint fusion with metal implants using a lateral transiliac approach: a prospective trial.

IF 3 3区 医学 Q1 ANESTHESIOLOGY
Pain Medicine Pub Date : 2025-06-26 DOI:10.1093/pm/pnaf082
Jacqueline Weisbein, Denis Patterson, Douglas Beall, Dan Nguyen, Jack Smith, Caroline Harstroem, Timothy Davis, Jeffrey Foster, Anne Christopher, Daniel Kloster, John Broadnax, Eric Anderson, John Hatheway, Andrew Trobridge, Charles Simmons, Thomas Stauss, Michael Harned, Christopher Mallard
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引用次数: 0

Abstract

Purpose: Sacroiliac joint (SIJ) pain, a frequent contributor to low back pain, is commonly treated with minimally invasive SIJ fusion. A large body of evidence supports the safety and effectiveness of lateral transiliac SIJ fusion. Traditionally performed by surgeons, this procedure is increasing in utilization by non-surgeon interventionalists. Herein, we present early safety results from a single-arm clinical trial of participants who underwent lateral SIJ fusion using threaded titanium implants placed by interventional pain management physicians.

Methods: STACI (NCT05870488) is a two-year prospective study conducted at 15 US interventional pain management sites. The primary endpoint is change in SIJ pain from baseline to 6-months. Secondary endpoints include changes in function (Oswestry Disability Index), quality of life (PROMIS-29), device or procedure-related adverse events, and evidence of fusion on CT scan at 2 years.

Results: 110 patients were enrolled. Mean (SD) participant age is 64 (14) years and 68% are female. Mean (SD) operative time was 44 minutes (16) and estimated blood loss was 14 cc (15). No serious or device-related adverse events have occurred. Reported perioperative adverse events include one surgical site infection and one hematoma. At 1-month follow-up, ODI improved by 18 points (p < 0.0001) and SIJ pain (NRS) decreased by 4 pts (p < 0.0001) from baseline.

Conclusion: Early results from this prospective multicenter study support the relative safety and early effectiveness of LTI SIJ fusion using a threaded implant when performed by interventional pain management physicians. The data are consistent with published literature with a low adverse event rate and early improvements in pain and function.

经髂外侧入路微创骶髂关节融合金属植入物的安全性和初步有效性:一项前瞻性试验。
目的:骶髂关节(SIJ)疼痛是腰痛的常见诱因,通常采用微创SIJ融合术治疗。大量的证据支持侧髂SIJ融合术的安全性和有效性。传统上由外科医生进行,这种手术越来越多地被非外科医生介入医师使用。在此,我们介绍了一项单臂临床试验的早期安全性结果,参与者使用介入疼痛管理医生放置的螺纹钛植入物进行外侧SIJ融合。方法:STACI (NCT05870488)是一项为期两年的前瞻性研究,在美国15个介入性疼痛管理中心进行。主要终点是SIJ疼痛从基线到6个月的变化。次要终点包括功能变化(Oswestry残疾指数)、生活质量(promise -29)、器械或手术相关不良事件以及2年CT扫描融合证据。结果:110例患者入组。参与者平均(SD)年龄为64(14)岁,68%为女性。平均(SD)手术时间为44分钟(16),估计失血量为14cc(15)。未发生严重或与器械相关的不良事件。报告的围手术期不良事件包括一例手术部位感染和一例血肿。在1个月的随访中,ODI提高了18个点(p)。结论:这项前瞻性多中心研究的早期结果支持介入疼痛管理医生使用螺纹种植体进行LTI SIJ融合的相对安全性和早期有效性。该数据与已发表的文献一致,不良事件发生率低,疼痛和功能早期改善。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Pain Medicine
Pain Medicine 医学-医学:内科
CiteScore
6.50
自引率
3.20%
发文量
187
审稿时长
3 months
期刊介绍: Pain Medicine is a multi-disciplinary journal dedicated to pain clinicians, educators and researchers with an interest in pain from various medical specialties such as pain medicine, anaesthesiology, family practice, internal medicine, neurology, neurological surgery, orthopaedic spine surgery, psychiatry, and rehabilitation medicine as well as related health disciplines such as psychology, neuroscience, nursing, nurse practitioner, physical therapy, and integrative health.
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