Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-31 @ 4:00 AM
Study NCT ID:
NCT01681004
Status:
COMPLETED
Last Update Posted:
2017-08-25
First Post:
2012-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Investigation of Sacroiliac Fusion Treatment (INSITE)
Sponsor:
SI-BONE, Inc.
Organization:
Study Overview
Official Title:
INSITE Investigation of Sacroiliac Fusion Treatment
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INSITE
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: