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Six-month outcomes from a randomized controlled trial of minimally invasive SI joint fusion with triangular titanium implants vs conservative management.

作者信息

Sturesson Bengt, Kools Djaya, Pflugmacher Robert, Gasbarrini Alessandro, Prestamburgo Domenico, Dengler Julius

机构信息

Department of Orthopedics, Aleris, Ängelholm Hospital, Ängelholm, Sweden.

Department of Neurosurgery, Onze-Lieve-Vrouw Hospital Aalst, Aalst, Belgium.

出版信息

Eur Spine J. 2017 Mar;26(3):708-719. doi: 10.1007/s00586-016-4599-9. Epub 2016 May 14.


DOI:10.1007/s00586-016-4599-9
PMID:27179664
Abstract

PURPOSE: To compare the safety and effectiveness of minimally invasive sacroiliac joint fusion (SIJF) using triangular titanium implants vs conservative management (CM) in patients with chronic sacroiliac joint (SIJ) pain. METHODS: 103 adults with chronic SIJ pain at nine sites in four European countries were randomly assigned to and underwent either minimally invasive SIJF using triangular titanium implants (N = 52) or CM (N = 51). CM was performed according to the European guidelines for the diagnosis and management of pelvic girdle pain and consisted of optimization of medical therapy, individualized physical therapy (PT) and adequate information and reassurance as part of a multifactorial treatment. The primary outcome was the difference in change in self-rated low back pain (LBP) at 6 months. Additional endpoints included quality of life using EQ-5D-3L, disability using Oswestry Disability Index (ODI), SIJ function using active straight leg raise (ASLR) test and adverse events. NCT01741025. RESULTS: At 6 months, mean LBP improved by 43.3 points in the SIJF group and 5.7 points in the CM group (difference of 38.1 points, p < 0.0001). Mean ODI improved by 26 points in the SIJF group and 6 points in the CM group (p < 0.0001). ASLR, EQ-5D-3L, walking distance and satisfaction were statistically superior in the SIJF group. The frequency of adverse events did not differ between groups. One case of postoperative nerve impingement occurred in the surgical group. CONCLUSIONS: In patients with chronic SIJ pain, minimally invasive SIJF using triangular titanium implants was safe and more effective than CM in relieving pain, reducing disability, improving patient function and quality of life.

摘要

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本文引用的文献

[1]
Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: A Prospective Study.

Global Spine J. 2015-8-11

[2]
Sacroiliac joint fusion for low back pain: a systematic review and meta-analysis.

Eur Spine J. 2016-6

[3]
Implant survivorship analysis after minimally invasive sacroiliac joint fusion using the iFuse Implant System(®).

Med Devices (Auckl). 2015-11-23

[4]
Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion Using Triangular Titanium Implants vs Nonsurgical Management for Sacroiliac Joint Dysfunction: 12-Month Outcomes.

Neurosurgery. 2015-11

[5]
A systematic review of minimally invasive sacroiliac joint fusion utilizing a lateral transarticular technique.

Int J Spine Surg. 2015-7-22

[6]
Is the Oswestry Disability Index a valid measure of response to sacroiliac joint treatment?

Qual Life Res. 2016-2

[7]
Percutaneous Sacroiliac Joint Fixation in Sacroiliac Instability. The First Case Report Using a Fully CT-Guided Technique.

Interv Neuroradiol. 2014-10-31

[8]
Five-year clinical and radiographic outcomes after minimally invasive sacroiliac joint fusion using triangular implants.

Open Orthop J. 2014-10-17

[9]
Back problems, comorbidities, and their association with wealth.

Spine J. 2015-1-1

[10]
Comparative effectiveness of open versus minimally invasive sacroiliac joint fusion.

Med Devices (Auckl). 2014-6-5

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