Sacroiliac Joint Fusion Versus Sham Operation for Treatment of Sacroiliac Joint Pain (NCT03507049) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Sacroiliac Joint Fusion Versus Sham Operation for Treatment of Sacroiliac Joint Pain
Norway, Sweden63 participantsStarted 2018-06-08
Plain-language summary
Sacroiliac joint fusion versus sham operasjon for treatment of sacroiliac pain. A prospective double blinded randomized controlled multicentre study.
Who can participate
Age range
21 Years – 70 Years
Sex
ALL
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 with suspected SIJ pain for \>6 months or \>18 months for pregnancy induced pelvic girdle pain.
. Diagnosis of the SI joint as the primary pain generator based on ALL of the following:
. Compression
. Posterior Pelvic Pain Provocation test - P4 (Thigh Thrust)
. Palpation of the long dorsal ligament
. Patrick's test (Faber)
. Leg Raise (ASLR )
Exclusion criteria
. Severe low 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary outcome measure - Numeric Rating Scale operated side
. 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
. Patients with prior successful fusion to the contra lateral side are exluded from the study.