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

NCT03507049 | Active Not Recruiting DMC

• 1 other identifier: 2017/1892 A
• Study Type: interventional
• Target: 63
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Sacroiliac Joint Somatic Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Baseline NRS

  baseline, 3, 6, 12 and 24 months

• Global NRS

  baseline,3 ,6 ,12 ,24 months

• NRS on non-operated side

  baseline, 3, 6, 12, 24 months

• NRS leg pain

  baseline, 3,6,12,24 months

• Oswestry disability index (ODI)

  baseline, 3, 6,12, 24 months

Other Outcomes (10)

• Adverse events

  3,6,12,24 months

• Change in Compression test of the sacroiliac joint

  baseline, 3, 6,12, 24 months

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

  baseline, 3, 6,12, 24 months

Study Arms (3)

Intervention group

ACTIVE COMPARATOR

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.

Procedure: iFuse

Sham group

SHAM COMPARATOR

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.

Procedure: sham group

Functional MRI study

OTHER

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.

Radiation: fMRI study

Interventions

iFuse PROCEDURE

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

Also known as: SI Bone iFuse

Intervention group

sham group PROCEDURE

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

Also known as: Sham surgery

Sham group

fMRI study RADIATION

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

Functional MRI study

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• \. Baseline Oswestry Disability Index (ODI) score of at least 30%
• \. Baseline lower back pain score of at least 5 on 0-10 point NRS
• \. Patient should have tried adequate forms of conservative treatment with little or no response.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead
• Karolinska University Hospital: collaborator

Study Sites (2)

Rikshospitalet, Oslo University Hospital

Oslo, 0424, Norway

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Related Publications (1)

• 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.

  PMID: 38328752 DERIVED

Study Officials

• Thomas Johan Dr Kibsgård, PhD, MD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

• Paul Dr Gerdhem, PhD, MD

  Karolinska University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant, associated professor

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

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: April 24, 2018
• Study Start: June 8, 2018
• Primary Completion: May 25, 2022
• Study Completion (Estimated): May 25, 2030
• Last Updated: July 11, 2022

Record last verified: 2022-07

Locations

NO (1); SE (1)