CompletedNot Applicable

iFuse Implant System® Minimally Invasive Arthrodesis

Belgium, Germany103 participantsStarted 2013-06

Plain-language summary

The purpose of this study is to compare outcomes when patients with chronic sacroiliac joint pain undergo either SI joint fusion with the iFuse Implant System or undergo conservative management of the SI joint

Who can participate

Age range21 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age 21-70 at time of screening
✓. Patient has lower back pain for \>6 months or \>18 months for pregnancy induced lower back pain
✓. 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)
✓. Baseline Oswestry Disability Index (ODI) score of at least 30%
✓. Baseline lower back pain score of at least 50 on 0-100 point VAS
✓. Patient has signed study-specific informed consent form
✓. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements

Exclusion criteria

✕. Severe lower back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, and lumbar vertebral body fracture
✕. Sacroiliac pathology caused by auto-immune disease (e.g. ankylosing spondylitis) and/or neoplasia (e.g. benign or malignant tumor) and/or crystal arthropathy
✕. 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.
✕. Spine surgery during the past 12 months.
✕. Previously diagnosed or suspected osteoporosis (defined as prior T-score \<-2.5 or history of osteoporotic fracture)
✕. Documented osteomalacia or other metabolic bone disease
✕. Any condition or anatomy that makes treatment with the iFuse Implant System infeasible
✕. Known allergy to titanium or titanium alloys

What they're measuring

The change in lower back pain as rated by the study subject using a 0-100 visual analog scale (VAS) at 6 months after initiation of treatment

Timeframe: 6 months

Trial details

NCT IDNCT01741025

SponsorSI-BONE, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-12-15

View on ClinicalTrials.gov More Sacroiliac Joint Pain trials