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Sacroiliac Joint Fusion Using Triangular Titanium Implants vs. Non-Surgical Management: Six-Month Outcomes from a Prospective Randomized Controlled Trial.

作者信息

Whang Peter, Cher Daniel, Polly David, Frank Clay, Lockstadt Harry, Glaser John, Limoni Robert, Sembrano Jonathan

机构信息

Department of Orthopaedics and Rehabilitation, Yale University School of Medicine, New Haven CT.

SI-BONE, Inc., San Jose, CA.

出版信息

Int J Spine Surg. 2015 Mar 5;9:6. doi: 10.14444/2006. eCollection 2015.


DOI:10.14444/2006
PMID:25785242
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4360612/
Abstract

BACKGROUND: Sacroiliac (SI) joint pain is a prevalent, underdiagnosed cause of lower back pain. SI joint fusion can relieve pain and improve quality of life in patients who have failed nonoperative care. To date, no study has concurrently compared surgical and non-surgical treatments for chronic SI joint dysfunction. METHODS: We conducted a prospective randomized controlled trial of 148 subjects with SI joint dysfunction due to degenerative sacroiliitis or sacroiliac joint disruptions who were assigned to either minimally invasive SI joint fusion with triangular titanium implants (N=102) or non-surgical management (NSM, n=46). SI joint pain scores, Oswestry Disability Index (ODI), Short-Form 36 (SF-36) and EuroQol-5D (EQ-5D) were collected at baseline and at 1, 3 and 6 months after treatment commencement. Six-month success rates, defined as the proportion of treated subjects with a 20-mm improvement in SI joint pain in the absence of severe device-related or neurologic SI joint-related adverse events or surgical revision, were compared using Bayesian methods. RESULTS: Subjects (mean age 51, 70% women) were highly debilitated at baseline (mean SI joint VAS pain score 82, mean ODI score 62). Six-month follow-up was obtained in 97.3%. By 6 months, success rates were 81.4% in the surgical group vs. 23.9% in the NSM group (difference of 56.6%, 95% posterior credible interval 41.4-70.0%, posterior probability of superiority >0.999). Clinically important (≥15 point) ODI improvement at 6 months occurred in 75% of surgery subjects vs. 27.3% of NSM subjects. At six months, quality of life improved more in the surgery group and satisfaction rates were high. The mean number of adverse events in the first six months was slightly higher in the surgical group compared to the non-surgical group (1.3 vs. 1.0 events per subject, p=0.1857). CONCLUSIONS: Six-month follow-up from this level 1 study showed that minimally invasive SI joint fusion using triangular titanium implants was more effective than non-surgical management in relieving pain, improving function and improving quality of life in patients with SI joint dysfunction due to degenerative sacroiliitis or SI joint disruptions. CLINICAL RELEVANCE: Minimally invasive SI joint fusion is an acceptable option for patients with chronic SI joint dysfunction due to degenerative sacroiliitis and sacroiliac joint disruptions unresponsive to non-surgical treatments.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8333/4360612/a12a9f91c6bd/IJSS-9-14444-2006-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8333/4360612/88c01621fbac/IJSS-9-14444-2006-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8333/4360612/009322731584/IJSS-9-14444-2006-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8333/4360612/6f131b63501f/IJSS-9-14444-2006-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8333/4360612/8cfb1dd8c7ff/IJSS-9-14444-2006-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8333/4360612/a12a9f91c6bd/IJSS-9-14444-2006-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8333/4360612/88c01621fbac/IJSS-9-14444-2006-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8333/4360612/009322731584/IJSS-9-14444-2006-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8333/4360612/6f131b63501f/IJSS-9-14444-2006-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8333/4360612/8cfb1dd8c7ff/IJSS-9-14444-2006-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8333/4360612/a12a9f91c6bd/IJSS-9-14444-2006-g005.jpg

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引用本文的文献

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Brain Spine. 2025-7-22

[2]
A Retrospective, Multicenter Analysis of a Novel Sacroiliac Joint Fusion Device on Safety and Efficacy at 12 Months: Access Study.

Healthcare (Basel). 2025-6-28

[3]
Management of sacroiliac joint pain: current concepts.

Eur J Orthop Surg Traumatol. 2025-5-21

[4]
Posterior allograft sacroiliac joint fusion with pre-operative mapping.

Interv Pain Med. 2025-4-4

[5]
Clinical outcome measures following lateral versus posterior sacroiliac joint fusion: Systematic review and meta-analysis.

Brain Spine. 2025-2-12

[6]
Efficacy of Lateral Sacroiliac Joint Fusion With the Trident™ Screw System: A Retrospective Analysis.

Cureus. 2025-1-21

[7]
The percentage of sacroiliac fusions done in the U.S. by non-surgical specialties has increased.

J Spine Surg. 2024-12-20

[8]
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[9]
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[10]
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本文引用的文献

[1]
Twelve-Month Follow-Up of a Randomized Trial Assessing Cooled Radiofrequency Denervation as a Treatment for Sacroiliac Region Pain.

Pain Pract. 2016-2

[2]
Five-year clinical and radiographic outcomes after minimally invasive sacroiliac joint fusion using triangular implants.

Open Orthop J. 2014-10-17

[3]
The anatomy of the lateral branches of the sacral dorsal rami: implications for radiofrequency ablation.

Pain Physician. 2014

[4]
One-year outcomes after minimally invasive sacroiliac joint fusion with a series of triangular implants: a multicenter, patient-level analysis.

Med Devices (Auckl). 2014-8-28

[5]
Sacroiliac joint pain: burden of disease.

Med Devices (Auckl). 2014-4-12

[6]
Pelvic joint fusion in patients with severe pelvic girdle pain - a prospective single-subject research design study.

BMC Musculoskelet Disord. 2014-3-15

[7]
Utilization of Minimally Invasive Surgical Approach for Sacroiliac Joint Fusion in Surgeon Population of ISASS and SMISS Membership.

Open Orthop J. 2014-1-24

[8]
Early results of sacro-iliac joint fixation following long fusion to the sacrum in adult spine deformity.

HSS J. 2013-12-11

[9]
Safety and 6-month effectiveness of minimally invasive sacroiliac joint fusion: a prospective study.

Med Devices (Auckl). 2013-12-13

[10]
Percutaneous arthrodesis of sacro-iliac joint: a pilot study.

J Neurosurg Sci. 2013-12

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