Sacroiliac Joint Fusion Versus Sham Operation for Treatment of Sacroiliac Joint Pain

Study Overview
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Brief Summary
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Sacroiliac joint fusion versus sham operasjon for treatment of sacroiliac pain. A prospective double blinded randomized controlled multicentre study.

Detailed Description
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Sacroiliac(SI) joint pain can lead to long-lasting severe pain and reduce physical function. It is shown to be the source of pain in 13-30% of patients with low back pain. Former surgical techniques had a high level of complications and low success rates. Newer mini-invasive surgical approaches have shown promising results in scientific studies. It is difficult to find an adequate control group for surgery as most patients already have tried conservative and alternative treatments without effect. A sham-designed study is the best alternative. This study is designed as a prospective randomized double blinded controlled mulitcenter trial. The investigators want to examine whether there is a difference in SI joint pain in patients operated with miniinvasive arthrodesis of the SI joint compared to a sham operated control group. Patients with SI joint pain are included. They will be randomized to either surgery with arthrodesis or sham surgery. Neither patient nor health personell who work with the patient after the surgery will know what has been done. The primary end point for the study is group difference in sacroiliac joint pain on the operated side after 6 months.

Official Title
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Sacroiliac Joint Fusion Versus Sham Operation for Treatment of Sacroiliac Joint Pain. A Prosepctive Double Blinded Randomized Controlled Multicenter Trial.

Conditions
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Sacroiliac Joint Somatic Dysfunction

Intervention / Treatment
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* Procedure: iFuse
* Procedure: sham group
* Radiation: fMRI study


Participation Criteria
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Eligibility Criteria
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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: 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) B. Patient has at least 3 of 6 physical examination maneuvers specific for SI joint pain: Compression Posterior Pelvic Pain Provocation test - P4 (Thigh Thrust) Palpation of the long dorsal ligament Patrick's test (Faber) Leg Raise (ASLR ) Geanslens test 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 (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 5 on 0-10 point NRS 6. Patient should have tried adequate forms of conservative treatment with little or no response. 7. Patient has signed study-specific informed consent 8. Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements. 9. Patients with unilateral or bilateral pain can be included in the study if they clearly can differentiate between the two sides. It is the most painful side that will be included and randomized to SIJ fusion or sham surgery in the study. 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 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial comparing sacroiliac joint fusion and sham surgery. A prospective double blinded randomized controlled multicenter trial.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>The intervention Group receives operation with SI-joint arthrodesis with the iFuse implant. The patient undergoes full anesthesia. The procedure starts with an approximately 5cm long skin incision over the posterolateral aspect of the pelvis. A guide-pin is inserted over the sacroiliac joint at the desired entry-point, verified by fluoroscopy. The surgeons drills and boraches over the pin and the ifuse implant is inserted. This is repeated for a total of three implants. The wound is closed with non-resorbable suture. An injection of the SIJ with local anesthetic is performed under guidance of fluoroscopy at the time of the procedure. | Procedure: iFuse<br>* ifuse will be implanted as described in section on the active comparator arm of the study.<br>* Other names: SI Bone iFuse;|
| Sham Comparator: Sham group<br>The sham operation will consist of the surgeon making the same skin incision as for an iFuse procedure, although nothing more, and then closing the wound. The patients undergoing a sham operation will be under general anesthesia for a random time of 20-40minutes in order to keep the two procedures as similar as possible. An injection of the SIJ with local anesthetic is performed under guidance of fluoroscopy at the time of the procedure. | Procedure: sham group<br>* sham surgery will be performed as desrcribed in section on sham comparator.<br>* Other names: Sham surgery;|
| Other: Functional MRI study<br>The Swedish patients will also undergo quantitative sensory testing at inclusion and at 6 month follow-up. At the same time they will undergo a cerebral MRI and a Functional MRI looking at activation of the CNS from pain in the sacroiliac joints induced by one leg lift. The purpose of this study is to look at contributing factors in treatment response. One hopes to map which CNS mechanisms are involved in causing the chronic pain these patients experience as well as how they respond to treatment. | Radiation: fMRI study<br>* Quantitative sensory testing, cerebral MRI and functional MRI will be done to examine pain mechanism and activation in the central nervous system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome measure - Numeric Rating Scale operated side | the primary endpoint is group difference in Numeric Rating Scale(NRS) pain-score on the operated side at six months postoperatively. Numeric rating scale is a pain-score scale from 0-10, where 0 is no pain and 10 is worst possible pain. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline NRS | Change from baseline Numeric Rating Scale (NRS) pain-score on the operated side at 3,6,12 and 24 months | baseline, 3, 6, 12 and 24 months | 
| Global NRS | Change from baseline global NRS at 3,6,12 and 24 months | baseline,3 ,6 ,12 ,24 months | 
| NRS on non-operated side | Change from baseline in non-operated side NRS at 3,6,12 and 24 months | baseline, 3, 6, 12, 24 months | 
| NRS leg pain | Change from baseline leg pain NRS at 3,6,12,24 months | baseline, 3,6,12,24 months | 
| Oswestry disability index (ODI) | Change in disability due to pelvic pain measured by Oswestry Disability Index(ODI) at 3,6,12,24 months | baseline, 3, 6,12, 24 months | 
| Pelvic girdle questionnaire | Change in disability due to pelvic pain measured by Pelvic Girdle Questionnaire(PGQ) at 3,6,12,24 months | baseline, 3, 6, 12, 24 months | 
| Quality of life (EQ-5D) | Change in quality of life measured by EQ-5D at 3,6,12,24 months | baseline, 3, 6, 12, 24 months | 
| Device breakage, loosening or migration on CT of the sacroiliac joint | Device breakage loosening or migration at 12 months judged by clinical symptoms and CT of the sacroiliac joint. | 12 months |