NCT03507049

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	iFuse	ifuse will be implanted as described in section on the active comparator arm of the study.
PROCEDURE	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.

Timeline

• Start date: 2018-06-08
• Primary completion: 2022-05-25
• Completion: 2030-05-25
• First posted: 2018-04-24
• Last updated: 2022-07-11

Locations

2 sites across 2 countries: Norway, Sweden