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

Sacroiliac Joint Somatic Dysfunction Clinical Trial

— SIFSO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03507049
• Other study ID #: 2017/1892 A
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 8, 2018
• Est. completion date: May 25, 2030

Study information

• Verified date: July 2022
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 63
• Est. completion date: May 25, 2030
• Est. primary completion date: May 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age 21-70 at time of screening

2. Patient with suspected SIJ pain for >6 months or >18 months for pregnancy induced pelvic girdle pain.

3. 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:

1. Compression

2. Posterior Pelvic Pain Provocation test - P4 (Thigh Thrust)

3. Palpation of the long dorsal ligament

4. Patrick's test (Faber)

5. Leg Raise (ASLR )

6. 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:

1. 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.

2. Sacroiliac pathology caused by auto-immune disease (e.g. ankylosing spondylitis) and/or neoplasia (e.g. benign or malignant tumor) and/or crystal arthropathy

3. 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.

4. Spine surgery during the past 12 months.

5. Previously diagnosed or suspected osteoporosis (defined as prior T-score <-2.5 or history of osteoporotic fracture)

6. Documented osteomalacia or other metabolic bone disease

7. Any condition or anatomy that makes treatment with the iFuse Implant System infeasible

8. Patients with prior successful fusion to the contra lateral side are exluded from the study.

Related Conditions & MeSH terms

• Arthralgia
• Sacroiliac Joint Somatic Dysfunction

Intervention

Procedure:
• iFuse
ifuse will be implanted as described in section on the active comparator arm of the study.
• sham group
sham surgery will be performed as desrcribed in section on sham comparator.

Radiation:
• fMRI study
Quantitative sensory testing, cerebral MRI and functional MRI will be done to examine pain mechanism and activation in the central nervous system.

Locations

Country	Name	City	State
Norway	Rikshospitalet, Oslo University Hospital	Oslo
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Karolinska University Hospital

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	registration of any adverse events after procedure completed	3,6,12,24 months
Other	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.	baseline, 3, 6,12, 24 months
Other	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.	baseline, 3, 6,12, 24 months
Other	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.	baseline, 3, 6,12, 24 months
Other	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. .	baseline, 3, 6,12, 24 months
Other	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.	baseline, 3, 6,12, 24 months
Other	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.	baseline, 3, 6,12, 24 months
Other	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.	baseline, 3, 6,12, 24 months.
Other	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.	baseline, 3, 6,12, 24 months.
Other	Work status	Patients will be asked to fill out standardized questionnaire on work status	baseline, 3, 6,12, 24 months.
Primary	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	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
Secondary	Global NRS	Change from baseline global NRS at 3,6,12 and 24 months	baseline,3 ,6 ,12 ,24 months
Secondary	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
Secondary	NRS leg pain	Change from baseline leg pain NRS at 3,6,12,24 months	baseline, 3,6,12,24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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