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iFuse Implant System® Minimally Invasive Arthrodesis — iMIA  

Sacroiliac Joint Pain Clinical Trial

Official title:
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.

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01741025
Study type Interventional
Source SI-BONE, Inc.
Contact
Status Completed
Phase N/A
Start date June 2013
Completion date September 24, 2017
View Details
See also
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