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.
Study Type
OBSERVATIONAL
Enrollment
194
Subject Success
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.
Time frame: Baseline and 6 months
Change in SI Joint Pain on Visual Analog Scale (VAS) (0-100 mm)
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.
Time frame: 24 months
Change in Back Dysfunction
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%.
Time frame: 24 months
Change in Quality of Life
Change in QOL as measured by Short Form-36 PCS and EQ-5D at post-operative visits
Time frame: Baseline and 24 months
Ambulatory Status
Percentage of population fully ambulatory at 24 months post operatively.
Time frame: 24 months
Work Status
Proportion of non-working subjects who return to work
Time frame: Basline, 24 months
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Spine and Neuro Center
Huntsville, Alabama, United States
Silicon Valley Spine
Campbell, California, United States
BASIC Spine
Newport Beach, California, United States
Southern California Center for Neuroscience and Spine (SCCNS)
Pomona, California, United States
St. Mary's Spine
San Francisco, California, United States
Neurosurgical and Spine Specialists
Parker, Colorado, United States
Orthopaedic Clinic of Daytona Beach
Daytona Beach, Florida, United States
The Orthopaedic Institute/NFRMC
Gainsville, Florida, United States
Bartow Regional Medical Center
Lakeland, Florida, United States
Piedmont Orhopaedics
Macon, Georgia, United States
...and 16 more locations
Serious Adverse Events
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.
Time frame: Procedure, discharge, 1,3,6,12,18 and 24 months