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采用新型皮质同种异体移植物的微创后路骶髂关节融合术:来自美国一个大型多中心队列的真实世界长期结果

Minimally Invasive Posterior SI Joint Fusion with a Novel Cortical Allograft: Real-World, Long-Term, Outcomes from a Large, Multisite US Cohort.

作者信息

Bovinet Chris, Antony Ajay, Azeem Nomen, Mehta Pankaj, Epter Richard S, Velagapudi Vivek, Tieppo Francio Vinicius, Lam Christopher M, Sayed Dawood

机构信息

The Spine Center of SE Georgia, Brunswick, GA, USA.

The Orthopedic Institute, Gainesville, FL, USA.

出版信息

Orthop Res Rev. 2025 Aug 14;17:381-390. doi: 10.2147/ORR.S538286. eCollection 2025.


DOI:10.2147/ORR.S538286
PMID:40832586
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12360366/
Abstract

PURPOSE: Sacroiliac (SI) joint dysfunction accounts for 15% to 30% of reported low back pain. Primary treatments of SI joint dysfunction include medications, bracing, physical therapy, injections, and ablations. When primary non-surgical treatments are unsuccessful, fusion or stabilization may be considered. Here, we report a multicenter study aimed to evaluate real-world outcomes of posterior sacroiliac joint fusion using cortical allograft across six United States clinical sites. METHODS: Patients diagnosed with sacroiliitis through physical examination and diagnostic injection who have failed conservative management that ultimately underwent percutaneous allograft implant with at least 6 months of follow up were included. Data extracted from electronic health records included demographic and clinical characteristics, Numeric Rating Scale (NRS) pain scores, and patient-reported adverse events. Descriptive statistics were utilized to summarize baseline characteristics, and proportion of patients achieving minimally clinically important difference (MCID) was assessed. Paired t-tests were employed to compare pre-operative and post-operative outcomes. RESULTS: A total of 258 patients were included. Of these, 63.9% were women and 36.1% were men, with a mean age of 69.2 years and an average body mass index of 29.6 kg/m². Average NRS at baseline was 7.61 ± 1.64 and 1.60 ± 1.86 (p < 0.05) at last follow-up visit. The mean pain reduction from baseline to the last follow-up (91.2 week mean or 1.75 years) was 6.01 points, exceeding MCID. The safety profile was favorable, with no serious adverse events reported in this cohort. CONCLUSION: Our findings affirm that posterior SI joint fusion constitutes an effective and enduring treatment option for patients suffering from SI joint dysfunction unresponsive to conservative care. The results indicate that posterior SI joint fusion is safe and effective at achieving sustained pain relief. Our findings are congruent with previously published studies and provide further evidence of sustained durable pain outcomes.

摘要

目的:骶髂关节功能障碍占所报告的腰痛病例的15%至30%。骶髂关节功能障碍的主要治疗方法包括药物治疗、支具治疗、物理治疗、注射治疗和消融治疗。当主要的非手术治疗失败时,可考虑进行融合或稳定手术。在此,我们报告一项多中心研究,旨在评估在美国六个临床地点使用皮质同种异体骨进行骶髂关节后路融合的实际效果。 方法:纳入通过体格检查和诊断性注射确诊为骶髂关节炎且保守治疗失败,最终接受经皮同种异体骨植入并至少随访6个月的患者。从电子健康记录中提取的数据包括人口统计学和临床特征、数字评分量表(NRS)疼痛评分以及患者报告的不良事件。采用描述性统计来总结基线特征,并评估达到最小临床重要差异(MCID)的患者比例。采用配对t检验比较术前和术后结果。 结果:共纳入258例患者。其中,63.9%为女性,36.1%为男性,平均年龄69.2岁,平均体重指数为29.6kg/m²。基线时平均NRS为7.61±1.64,末次随访时为1.60±1.86(p<0.05)。从基线到末次随访(平均91.2周或1.75年)的平均疼痛减轻为6.01分,超过了MCID。安全性良好,该队列中未报告严重不良事件。 结论:我们的研究结果证实,骶髂关节后路融合术是对保守治疗无反应的骶髂关节功能障碍患者的一种有效且持久的治疗选择。结果表明,骶髂关节后路融合术在实现持续疼痛缓解方面是安全有效的。我们的研究结果与先前发表的研究一致,并为持续持久的疼痛结果提供了进一步的证据。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a42/12360366/786b52cf140e/ORR-17-381-g0005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a42/12360366/e84fd65df4b3/ORR-17-381-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a42/12360366/d37e231687a5/ORR-17-381-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a42/12360366/2bcdbaad73ce/ORR-17-381-g0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a42/12360366/d6b1e6e16dab/ORR-17-381-g0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a42/12360366/786b52cf140e/ORR-17-381-g0005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a42/12360366/e84fd65df4b3/ORR-17-381-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a42/12360366/d37e231687a5/ORR-17-381-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a42/12360366/2bcdbaad73ce/ORR-17-381-g0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a42/12360366/d6b1e6e16dab/ORR-17-381-g0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a42/12360366/786b52cf140e/ORR-17-381-g0005.jpg

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本文引用的文献

[1]
Posterior Sacroiliac Fusion Surgery: A Retrospective Single Center Study.

Pain Physician. 2024-7

[2]
American Society of Pain and Neuroscience Best Practice (ASPN) Guideline for the Treatment of Sacroiliac Disorders.

J Pain Res. 2024-5-3

[3]
Impact of Sacroiliac Belt Utilization on Balance in Patients with Low Back Pain.

Orthop Rev (Pavia). 2024-4-30

[4]
Safety, Efficacy, and Durability of Outcomes: Results from SECURE: A Single Arm, Multicenter, Prospective, Clinical Study on a Minimally Invasive Posterior Sacroiliac Fusion Allograft Implant.

J Pain Res. 2024-3-20

[5]
Minimally Invasive SI Joint Fusion Procedures for Chronic SI Joint Pain: Systematic Review and Meta-Analysis of Safety and Efficacy.

Int J Spine Surg. 2023-12-26

[6]
Posterior intra-articular fixation stabilizes both primary and secondary sacroiliac joints: a cadaveric study and comparison to lateral trans-articular fixation literature.

J Orthop Surg Res. 2023-6-3

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MMWR Morb Mortal Wkly Rep. 2023-4-14

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Six Month Interim Outcomes from SECURE: A Single arm, Multicenter, Prospective, Clinical Study on a Novel Minimally Invasive Posterior Sacroiliac Fusion Device.

Expert Rev Med Devices. 2022-5

[10]
A global study of pain prevalence across 52 countries: examining the role of country-level contextual factors.

Pain. 2022-9-1

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