NCT01681004

Investigation of Sacroiliac Fusion Treatment (INSITE)

INSITE Investigation of Sacroiliac Fusion Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 159 (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 degenerative sacroiliitis (arthritis of the SI joint) and or sacroiliac disruption (abnormal separation or tearing of the sacroiliac joint)undergo either SI joint fusion with the iFuse Implant System or undergo specific, targeted non-surgical treatment of the SI joint.

Detailed description

The intended analysis was to examine differences in responses at 6 months. It was acknowledged that subjects with chronic pain in the NSM arm group might not experience any benefit as there was little evidence at the time that NSM was helpful. The protocol included optional crossover to other treatments, including surgical treatment. The protocol anticipated a high crossover rate and therefore did not include any comparative analyses after month 6.

Conditions

• Degenerative Sacroiliitis
• Sacroiliac Joint Disruption

Interventions

Type	Name	Description
DEVICE	iFuse Implant System	Placement of iFuse implant system via surgery
OTHER	Non-surgical management	Medications for pain, physical therapy, SI joint injection and RF ablation

Timeline

• Start date: 2012-09-01
• Primary completion: 2015-02-01
• Completion: 2017-06-01
• First posted: 2012-09-07
• Last updated: 2017-08-25
• Results posted: 2017-08-25

Locations

19 sites across 1 country: United States