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

NCT ID: NCT03507049

Last Updated: 2022-07-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-08
• Study Completion Date: 2030-05-25

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.

Conditions

Sacroiliac Joint Somatic Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

iFuse

Intervention Type: PROCEDURE

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

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.

Group Type: SHAM_COMPARATOR

sham group

Intervention Type: PROCEDURE

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

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.

Group Type: OTHER

fMRI study

Intervention Type: RADIATION

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

Interventions

iFuse

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

Intervention Type: PROCEDURE

sham group

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

Intervention Type: PROCEDURE

fMRI study

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

Intervention Type: RADIATION

Other Intervention Names

SI Bone iFuse; Sham surgery

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska University Hospital

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Thomas Johan Kibsgård

Senior consultant, associated professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Johan Dr Kibsgård, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Paul Dr Gerdhem, PhD, MD

Role: STUDY_CHAIR

Karolinska University Hospital

Locations

Rikshospitalet, Oslo University Hospital

Oslo, , Norway

Karolinska University Hospital

Stockholm, , Sweden

Countries

Norway; Sweden

References

Randers EM, Gerdhem P, Stuge B, Diarbakerli E, Nordsletten L, Rohrl SM, Kibsgard TJ. The effect of minimally invasive sacroiliac joint fusion compared to sham operation: a double-blind randomized placebo-controlled trial. EClinicalMedicine. 2024 Feb 1;68:102438. doi: 10.1016/j.eclinm.2024.102438. eCollection 2024 Feb.

Reference Type: DERIVED

PMID: 38328752 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017/1892 A

Identifier Type: -

Identifier Source: org_study_id