NCT01741025

iFuse Implant System® Minimally Invasive Arthrodesis

A Multicenter Randomized Controlled Post-market Clinical Follow-up Trial Comparing the Effectiveness and Safety of the iFuse Implant System® Versus Conservative Management for Patients With Chronic, Disabling SI Joint Pain.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: SI-BONE, Inc. · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare outcomes when patients with chronic sacroiliac joint pain undergo either SI joint fusion with the iFuse Implant System or undergo conservative management of the SI joint

Detailed description

This study is a multicenter randomized controlled, post-market clinical follow-up clinical trial of the iFuse Implant System for SI joint fusion vs. conservative management. Subjects assigned to conservative management may cross over to iFuse after a minimum of 6 months of conservative treatment. Conservative management does not include interventional procedures such as prolotherapy, steroid injections and/or RF ablation.

Conditions

• Sacroiliac Joint Pain

Interventions

Type	Name	Description
DEVICE	iFuse Implant System	Placement of iFuse implant system via surgery
OTHER	Conservative Management	Medications for pain, physical therapy, cognitive behavour therapy

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-12-15
• Completion: 2017-09-24
• First posted: 2012-12-04
• Last updated: 2017-10-03

Locations

9 sites across 4 countries: Belgium, Germany, Italy, Sweden