Back to results

Sacroiliac Joint Fusion Versus Sham Operation for Treatment of Sacroiliac Joint Pain (SIFSO)

Primary Purpose

Sacroiliac Joint Somatic Dysfunction

Status

Active

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

iFuse

sham group

fMRI study

About this trial

This is an interventional treatment trial for Sacroiliac Joint Somatic Dysfunction

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Rikshospitalet, Oslo University Hospital
Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Other

Arm Label

Intervention group

Sham group

Functional MRI study

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Baseline NRS

Change from baseline Numeric Rating Scale (NRS) pain-score on the operated side at 3,6,12 and 24 months

Global NRS

Change from baseline global NRS at 3,6,12 and 24 months

NRS on non-operated side

Change from baseline in non-operated side NRS at 3,6,12 and 24 months

NRS leg pain

Change from baseline leg pain NRS at 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

Pelvic girdle questionnaire

Change in disability due to pelvic pain measured by Pelvic Girdle Questionnaire(PGQ) at 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

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.

Full Information

NCT ID

NCT03507049

First Posted

April 6, 2018

Last Updated

July 6, 2022

Sponsor

Oslo University Hospital

Collaborators

Karolinska University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03507049

Brief Title

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

Acronym

SIFSO

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

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 8, 2018 (Actual)

Primary Completion Date

May 25, 2022 (Actual)

Study Completion Date

May 25, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oslo University Hospital

Collaborators

Karolinska University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sacroiliac Joint Somatic Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized controlled trial comparing sacroiliac joint fusion and sham surgery. A prospective double blinded randomized controlled multicenter trial.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

double blinded

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Active Comparator

Arm Description

Arm Title

Sham group

Arm Type

Sham Comparator

Arm Description

Arm Title

Functional MRI study

Arm Type

Other

Arm Description

Intervention Type

Procedure

Intervention Name(s)

iFuse

Other Intervention Name(s)

SI Bone iFuse

Intervention Description

ifuse will be implanted as described in section on the active comparator arm of the study.

Intervention Type

Procedure

Intervention Name(s)

sham group

Other Intervention Name(s)

Sham surgery

Intervention Description

sham surgery will be performed as desrcribed in section on sham comparator.

Intervention Type

Radiation

Intervention Name(s)

fMRI study

Intervention Description

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 Information:

Title

Primary outcome measure - Numeric Rating Scale operated side

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Baseline NRS

Description

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

Title

Global NRS

Description

Change from baseline global NRS at 3,6,12 and 24 months

Time Frame

baseline,3 ,6 ,12 ,24 months

Title

NRS on non-operated side

Description

Change from baseline in non-operated side NRS at 3,6,12 and 24 months

Time Frame

baseline, 3, 6, 12, 24 months

Title

NRS leg pain

Description

Change from baseline leg pain NRS at 3,6,12,24 months

Time Frame

baseline, 3,6,12,24 months

Title

Oswestry disability index (ODI)

Description

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

Title

Pelvic girdle questionnaire

Description

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

Title

Quality of life (EQ-5D)

Description

Change in quality of life measured by EQ-5D at 3,6,12,24 months

Time Frame

baseline, 3, 6, 12, 24 months

Title

Device breakage, loosening or migration on CT of the sacroiliac joint

Description

Device breakage loosening or migration at 12 months judged by clinical symptoms and CT of the sacroiliac joint.

Time Frame

12 months

Other Pre-specified Outcome Measures:

Title

Adverse events

Description

registration of any adverse events after procedure completed

Time Frame

3,6,12,24 months

Title

Change in Compression test of the sacroiliac joint

Description

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

Title

Change in Posterior Pelvic Pain Provocation (P4) test of the sacroiliac joint

Description

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

Title

Change in Palpation of long dorsal ligament as test of the sacroiliac joint

Description

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

Title

Change in Patricks (FABER) test of the sacroiliac joint

Description

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

Title

Change in active straight leg raise test (ASLR) of the sacroiliac joint

Description

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

Title

Change in Gaenslens test

Description

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

Title

6 minute walk test to record ambulatory status

Description

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.

Title

Timed up and og test to record ambulatory status

Description

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.

Title

Work status

Description

Patients will be asked to fill out standardized questionnaire on work status

Time Frame

baseline, 3, 6,12, 24 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Johan Dr Kibsgård, PhD, MD

Organizational Affiliation

Oslo University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Paul Dr Gerdhem, PhD, MD

Organizational Affiliation

Karolinska University Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Rikshospitalet, Oslo University Hospital

City

Oslo

ZIP/Postal Code

0424

Country

Norway

Facility Name

Karolinska University Hospital

City

Stockholm

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs