Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
103 participants
INTERVENTIONAL
2013-06-30
2017-09-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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iFuse Implant System
Surgical placement of iFuse implants in the affected SI joint
iFuse Implant System
Placement of iFuse implant system via surgery
conservative management
Medications, physical therapy, information
Conservative Management
Medications for pain, physical therapy, cognitive behavour therapy
Interventions
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iFuse Implant System
Placement of iFuse implant system via surgery
Conservative Management
Medications for pain, physical therapy, cognitive behavour therapy
Eligibility Criteria
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Inclusion Criteria
2. Patient has lower back pain for \>6 months or \>18 months for pregnancy induced lower back pain
3. Diagnosis of the SI joint as the primary lower back pain generator based on ALL of the following: a. Patient has pain at or close to the posterior superior iliac spine (PSIS) with possible radiation into buttocks, posterior thigh or groin and can point with a single finger to the location of pain (Fortin Finger Test), and b. Patient has at least 3 of 5 physical examination maneuvers specific for SI joint pain, and c. Patient has improvement in lower back pain NRS of at least 50% of the pre injection NRS score after fluoroscopic controlled injection of local anesthetic into affected SI joint(s) (including previous documented test \<6 months ago)
4. Baseline Oswestry Disability Index (ODI) score of at least 30%
5. Baseline lower back pain score of at least 50 on 0-100 point VAS
6. Patient has signed study-specific informed consent form
7. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements
Exclusion Criteria
2. Sacroiliac pathology caused by auto-immune disease (e.g. ankylosing spondylitis) and/or neoplasia (e.g. benign or malignant tumor) and/or crystal arthropathy
3. History of recent (\<1 year) fracture of the pelvis with documented malunion, non-union of sacrum or ilium or any type of internal fixation of the pelvic ring.
4. Spine surgery during the past 12 months.
5. Previously diagnosed or suspected osteoporosis (defined as prior T-score \<-2.5 or history of osteoporotic fracture)
6. Documented osteomalacia or other metabolic bone disease
7. Any condition or anatomy that makes treatment with the iFuse Implant System infeasible
8. Known allergy to titanium or titanium alloys
9. Use of medications known to have detrimental effects on bone quality and soft-tissue healing
10. Prominent neurologic condition that would interfere with physical therapy
11. Current systemic infection or local infection at the SI joint
12. Currently pregnant or planning pregnancy in the next year
13. Known or suspected drug or alcohol abuse
14. Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation
15. Patient is participating in an investigational study or has been involved in an investigational study within 3 months of surgery
21 Years
70 Years
ALL
No
Sponsors
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SI-BONE, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Cher
Role: STUDY_DIRECTOR
SI-BONE, Inc.
Locations
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OLV Ziekenhuis Aalst
Aalst, , Belgium
La Clinique de l'Espérance
Montegnée, , Belgium
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Universitätsklinikum Bonn
Bonn, , Germany
Praxisgemeinschaft "Leben in Bewegung"
Hilden, , Germany
Istituto Ortopedico Rizzoli
Bologna, , Italy
Ospedale Civile Di Legnano
Legnano, , Italy
IRCCS Policlinico San Matteo
Pavia, , Italy
Aleris Specialistvård Ängelholm, Ortopedkliniken
Ängelholm, , Sweden
Countries
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References
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Dat KO, Cher D, Polly DW. Effects of BMI on SI joint fusion outcomes: examining the evidence to improve insurance guidelines. Spine J. 2024 May;24(5):783-790. doi: 10.1016/j.spinee.2023.11.015. Epub 2023 Dec 9.
Dengler JD, Kools D, Pflugmacher R, Gasbarrini A, Prestamburgo D, Gaetani P, van Eeckhoven E, Cher D, Sturesson B. 1-Year Results of a Randomized Controlled Trial of Conservative Management vs. Minimally Invasive Surgical Treatment for Sacroiliac Joint Pain. Pain Physician. 2017 Sep;20(6):537-550.
Dengler J, Sturesson B, Kools D, Prestamburgo D, Cher D, van Eeckhoven E, Erk E, Pflugmacher R, Vajkoczy P; the iMIA study group. Referred leg pain originating from the sacroiliac joint: 6-month outcomes from the prospective randomized controlled iMIA trial. Acta Neurochir (Wien). 2016 Nov;158(11):2219-2224. doi: 10.1007/s00701-016-2953-7. Epub 2016 Sep 15.
Sturesson B, Kools D, Pflugmacher R, Gasbarrini A, Prestamburgo D, Dengler J. Six-month outcomes from a randomized controlled trial of minimally invasive SI joint fusion with triangular titanium implants vs conservative management. Eur Spine J. 2017 Mar;26(3):708-719. doi: 10.1007/s00586-016-4599-9. Epub 2016 May 14.
Study Documents
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Document Type: publication 6 month results
View DocumentDocument Type: publication 6 month results
View DocumentOther Identifiers
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300134
Identifier Type: -
Identifier Source: org_study_id