CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 159 enrolled
Drug / intervention
iFuse Implant System +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01681004
NCT01681004N/ACompleted
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INSITE Investigation of Sacroiliac Fusion Treatment

SI-BONE, Inc.·interventional·Posted Sep 7, 2012·Updated Aug 25, 2017

In Brief

A clinical study evaluating iFuse Implant System and Non-surgical management for Degenerative Sacroiliitis and Sacroiliac Joint Disruption. Completed, enrolled 159 participants across 19 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDegenerative Sacroiliitis, Sacroiliac Joint Disruption
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 7, 2012
Enrollment StartSep 1, 2012
Primary CompletionFeb 1, 2015
Study CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 13.8 years ago

Interventions

iFuse Implant Systemdevice

Placement of iFuse implant system via surgery

Non-surgical managementother

Medications for pain, physical therapy, SI joint injection and RF ablation