- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03507049
Sacroiliac Joint Fusion Versus Sham Operation for Treatment of Sacroiliac Joint Pain (SIFSO)
Sacroiliac Joint Fusion Versus Sham Operation for Treatment of Sacroiliac Joint Pain. A Prosepctive Double Blinded Randomized Controlled Multicenter Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intervention group
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.
|
ifuse will be implanted as described in section on the active comparator arm of the study.
Other Names:
|
Sham Comparator: Sham group
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. |
sham surgery will be performed as desrcribed in section on sham comparator.
Other Names:
|
Other: Functional MRI study
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.
|
Quantitative sensory testing, cerebral MRI and functional MRI will be done to examine pain mechanism and activation in the central nervous system.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary outcome measure - Numeric Rating Scale operated side
Time Frame: 6 months
|
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
Time Frame: baseline, 3, 6, 12 and 24 months
|
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
Time Frame: baseline,3 ,6 ,12 ,24 months
|
Change from baseline global NRS at 3,6,12 and 24 months
|
baseline,3 ,6 ,12 ,24 months
|
NRS on non-operated side
Time Frame: baseline, 3, 6, 12, 24 months
|
Change from baseline in non-operated side NRS at 3,6,12 and 24 months
|
baseline, 3, 6, 12, 24 months
|
NRS leg pain
Time Frame: baseline, 3,6,12,24 months
|
Change from baseline leg pain NRS at 3,6,12,24 months
|
baseline, 3,6,12,24 months
|
Oswestry disability index (ODI)
Time Frame: baseline, 3, 6,12, 24 months
|
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
Time Frame: baseline, 3, 6, 12, 24 months
|
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)
Time Frame: baseline, 3, 6, 12, 24 months
|
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
Time Frame: 12 months
|
Device breakage loosening or migration at 12 months judged by clinical symptoms and CT of the sacroiliac joint.
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events
Time Frame: 3,6,12,24 months
|
registration of any adverse events after procedure completed
|
3,6,12,24 months
|
Change in Compression test of the sacroiliac joint
Time Frame: baseline, 3, 6,12, 24 months
|
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.
|
baseline, 3, 6,12, 24 months
|
Change in Posterior Pelvic Pain Provocation (P4) test of the sacroiliac joint
Time Frame: baseline, 3, 6,12, 24 months
|
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.
|
baseline, 3, 6,12, 24 months
|
Change in Palpation of long dorsal ligament as test of the sacroiliac joint
Time Frame: baseline, 3, 6,12, 24 months
|
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.
|
baseline, 3, 6,12, 24 months
|
Change in Patricks (FABER) test of the sacroiliac joint
Time Frame: baseline, 3, 6,12, 24 months
|
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. .
|
baseline, 3, 6,12, 24 months
|
Change in active straight leg raise test (ASLR) of the sacroiliac joint
Time Frame: baseline, 3, 6,12, 24 months
|
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.
|
baseline, 3, 6,12, 24 months
|
Change in Gaenslens test
Time Frame: baseline, 3, 6,12, 24 months
|
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.
|
baseline, 3, 6,12, 24 months
|
6 minute walk test to record ambulatory status
Time Frame: baseline, 3, 6,12, 24 months.
|
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.
|
baseline, 3, 6,12, 24 months.
|
Timed up and og test to record ambulatory status
Time Frame: baseline, 3, 6,12, 24 months.
|
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.
|
baseline, 3, 6,12, 24 months.
|
Work status
Time Frame: baseline, 3, 6,12, 24 months.
|
Patients will be asked to fill out standardized questionnaire on work status
|
baseline, 3, 6,12, 24 months.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas Johan Dr Kibsgård, PhD, MD, Oslo University Hospital
- Study Chair: Paul Dr Gerdhem, PhD, MD, Karolinska University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/1892 A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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