Clinical trial NCT03507049: Sacroiliac Joint Fusion Versus Sham Operation for Treatment of Sacroiliac Joint Pain
Official title: Sacroiliac Joint Fusion Versus Sham Operation for Treatment of Sacroiliac Joint Pain. A Prosepctive Double Blinded Randomized Controlled Multicenter Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sacroiliac Joint Somatic Dysfunction
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2018-04-24
Enrollment: 63
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial comparing sacroiliac joint fusion and sham surgery. A prospective double blinded randomized controlled multicenter trial.
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary outcome measure - Numeric Rating Scale operated side
timeFrame: 6 months
Secondary outcomes:
measure: Baseline NRS
timeFrame: baseline, 3, 6, 12 and 24 months
measure: Global NRS
timeFrame: baseline,3 ,6 ,12 ,24 months
measure: NRS on non-operated side
timeFrame: baseline, 3, 6, 12, 24 months
measure: NRS leg pain
timeFrame: baseline, 3,6,12,24 months
measure: Oswestry disability index (ODI)
timeFrame: baseline, 3, 6,12, 24 months
measure: Pelvic girdle questionnaire
timeFrame: baseline, 3, 6, 12, 24 months
measure: Quality of life (EQ-5D)
timeFrame: baseline, 3, 6, 12, 24 months
measure: Device breakage, loosening or migration on CT of the sacroiliac joint
timeFrame: 12 months
Other outcomes:
measure: Adverse events
timeFrame: 3,6,12,24 months
measure: Change in Compression test of the sacroiliac joint
timeFrame: baseline, 3, 6,12, 24 months
measure: Change in Posterior Pelvic Pain Provocation (P4) test of the sacroiliac joint
timeFrame: baseline, 3, 6,12, 24 months
measure: Change in Palpation of long dorsal ligament as test of the sacroiliac joint
timeFrame: baseline, 3, 6,12, 24 months
measure: Change in Patricks (FABER) test of the sacroiliac joint
timeFrame: baseline, 3, 6,12, 24 months
measure: Change in active straight leg raise test (ASLR) of the sacroiliac joint
timeFrame: baseline, 3, 6,12, 24 months
measure: Change in Gaenslens test
timeFrame: baseline, 3, 6,12, 24 months
measure: 6 minute walk test to record ambulatory status
timeFrame: baseline, 3, 6,12, 24 months.
measure: Timed up and og test to record ambulatory status
timeFrame: baseline, 3, 6,12, 24 months.
measure: Work status
timeFrame: baseline, 3, 6,12, 24 months.
Locations:
city: Oslo
country: Norway
facility: Rikshospitalet, Oslo University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Thomas Johan Dr Kibsgård, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska University Hospital
name: Paul Dr Gerdhem, PhD, MD
role: STUDY_CHAIR
References: