Sacroiliac Joint Fusion With iFuse Implant System (SIFI) (SIFI)
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The purpose of this study is to evaluate the use of the iFuse Implant System to treat degenerative sacroiliitis (arthritis of the SI joint) and sacroiliac disruption (abnormal separation or tearing of the sacroiliac joint). The iFuse Implant System (iFuse device) is a medical device that is surgically implanted into the sacroiliac (SI) joint during a minimally invasive surgical procedure (one that uses a smaller incision and less damage to the skin and other tissues than standard surgery). The purpose of implanting the device is to stabilize and fuse the SI joint.
Subject Success [ Time Frame: Baseline and 6 months ]
Composite endpoint of reduction from baseline in VAS back pain score by at least 20 mm, lack of device-related serious adverse events, absence of neurologic worsening and absence of surgical re-intervention.
Secondary Outcome Measures
Change in SI Joint Pain on Visual Analog Scale (VAS) (0-100 mm) [ Time Frame: 24 months ]
The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain.
Change in Back Dysfunction [ Time Frame: 24 months ]
Oswestry Disability Index is a validated patient questionnaire aiming to assess low back pain. The computed scores can be 0% to 100%. Lower scores indicate low disability while high scores indicate high disability. There are 10 questions on the questionnaire. Each has 6 possible answers (0 points - 5 points). If the question is skipped, it's points are subtracted from the denominator. If the raw score is 30 and all 10 questions were answered, the calculation would be 30 / 50 = 60%. If one question was skipped, it would be 30 / 45 = 67%.
Change in Quality of Life [ Time Frame: Baseline and 24 months ]
Change in QOL as measured by Short Form-36 PCS and EQ-5D at post-operative visits
Ambulatory Status [ Time Frame: 24 months ]
Percentage of population fully ambulatory at 24 months post operatively.
Work Status [ Time Frame: Basline, 24 months ]
Proportion of non-working subjects who return to work
Serious Adverse Events [ Time Frame: Procedure, discharge, 1,3,6,12,18 and 24 months ]
Occurrence of adverse events meeting the ISO14155:2011 definition of serious occurring during the procedure, at the time of hospital discharge (typically day of or next day after procedure), and at various times in late follow-up.
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Ages Eligible for Study:
21 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects with SI joint pain due to degeneration or disruption of the SI joint
1. Age 21-70 at time of screening
2. Patient has lower back pain for >6 months inadequately responsive to conservative care
3. Diagnosis of sacroiliac joint disruption or degenerative sacroiliitis based on ALL of the following:
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
Patient has at least 3 of 5 physical examination maneuvers specific for the SI joint (see Table 3), and
Patient has improvement in lower back pain numeric rating scale (NRS) of at least 50% after injection of local anesthetic into affected SI joint(s) (see Section 3.6.4), and
One or more of the following:
i. SI joint disruption:
Asymmetric SI joint widening on X-ray or CT scan
Leakage of contrast on diagnostic arthrography
ii. Degenerative sacroiliitis:
Radiographic evidence of SI joint degeneration, including sclerosis,osteophytes, subchondral cysts, or vacuum phenomenon on CT or plain film, or
Due to prior lumbosacral spine fusion
4. Baseline Oswestry Disability Index (ODI) score of at least 30% 5. Baseline SI joint pain score of at least 50 on 0-100 mm visual analog scale 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
Severe 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
Other known sacroiliac pathology such as:
Inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated spondyloarthropathy)
History of recent (< 1 year) major trauma to pelvis
Previously diagnosed osteoporosis (defined as prior T-score <-2.5 or history of osteoporotic fracture).