An interventional study of iFuse and sham group in Sacroiliac Joint Somatic Dysfunction, sponsored by Oslo University Hospital. Active, not recruiting at 2 sites in 2 countries. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-07-11.
Sponsored by Oslo University Hospital · Not applicable, Interventional, and Treatment
Sacroiliac joint fusion versus sham operasjon for treatment of sacroiliac pain. A prospective double blinded randomized controlled multicentre study.
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.
273 studies on the registry are indexed under Arthralgia; 41 are open to participants now.
This study's enrollment of 63 is close to the median of 63 across 219 interventional studies indexed under Arthralgia.
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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:
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)
Exclusion Criteria:
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
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
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
ifuse will be implanted as described in section on the active comparator arm of the study.
Also known as: SI Bone iFuse
sham surgery will be performed as desrcribed in section on sham comparator.
Also known as: Sham surgery
Quantitative sensory testing, cerebral MRI and functional MRI will be done to examine pain mechanism and activation in the central nervous system.
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.
Time frame: 6 months
Baseline NRS
Change from baseline Numeric Rating Scale (NRS) pain-score on the operated side at 3,6,12 and 24 months
Time frame: baseline, 3, 6, 12 and 24 months
Global NRS
Change from baseline global NRS at 3,6,12 and 24 months
Time frame: 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
Time frame: baseline, 3, 6, 12, 24 months
NRS leg pain
Change from baseline leg pain NRS at 3,6,12,24 months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 12 months
Adverse events
registration of any adverse events after procedure completed
Time frame: 3,6,12,24 months
Change in Compression test of the sacroiliac joint
Change in compression test of the sacroiliac joint which is an objective clinical test. Outcome is negative or positive test dependent on whether pain is provoked or not in the sacroiliac joint.
Time frame: baseline, 3, 6,12, 24 months
Change in Posterior Pelvic Pain Provocation (P4) test of the sacroiliac joint
Change in Posterior Pelvic pain Provocation (P4) test of the sacroiliac joint which is an objective clinical test. Outcome is negative or positive test dependent on whether pain is provoked or not in the sacroiliac joint.
Time frame: baseline, 3, 6,12, 24 months
Change in Palpation of long dorsal ligament as test of the sacroiliac joint
Change in Palpation of long dorsal ligament as test of the sacroiliac joint which is an objective clinical test. Outcome is negative or positive test dependent on whether pain is provoked or not along the ligament.
Time frame: baseline, 3, 6,12, 24 months
Change in Patricks (FABER) test of the sacroiliac joint
Change in Patricks (FABER) test of the sacroiliac joint which is an objective clinical test. Outcome is negative or positive test dependent on whether pain is provoked or not in the sacroiliac joint. .
Time frame: baseline, 3, 6,12, 24 months
Change in active straight leg raise test (ASLR) of the sacroiliac joint
Change in active straight leg raise test(ASLR) of the sacroiliac joint which is an objective clinical test. Results are recorded on a grad 0 to 5, where not difficult at all = 0; minimally difficult = 1; somewhat difficult = 2; fairly difficult = 3; very difficult = 4; unable to do = 5.
Time frame: baseline, 3, 6,12, 24 months
Change in Gaenslens test
Change in Gaenslens test which is an objective clinical tests for the sacroiliac joint. Outcome is recorded as positive or negative test dependent on whether pain is provoked or not in the sacroiliac joint.
Time frame: baseline, 3, 6,12, 24 months
6 minute walk test to record ambulatory status
Patients will be tested with 6minute walk test to test ambulatory status. The test is performed by marking a distance equal to 50meters. The patient is instructed to walk back and forth between the marks as quickly and as many times as they manage in 6 minutes. The total distance walked is recorded.
Time frame: baseline, 3, 6,12, 24 months.
Timed up and og test to record ambulatory status
Patients will be tested with Timed up and go, to test ambulatory status.Timed up and go test the time it takes the patient to get up from a Chair, walk 3 meters and back and be seated again.
Time frame: baseline, 3, 6,12, 24 months.
Work status
Patients will be asked to fill out standardized questionnaire on work status
Time frame: baseline, 3, 6,12, 24 months.
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Oslo University Hospital