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NCT01681004 · ClinicalTrials.gov registry record · NA
Investigation of Sacroiliac Fusion Treatment (INSITE)
A NA study, sponsored by SI-BONE.
- Completed
- Registry status
- NA
- Development phase
- 159
- Enrollment target
NCT01681004: Completed NA study, sponsored by SI-BONE.
NCT01681004 is a NA study that has completed, run by SI-BONE. The registered enrollment target is 159 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01681004, a NA study, has completed, sponsored by SI-BONE.
- COMPLETED
- Registry status
- NA
- Development phase
- 159 participants
- Enrollment target
Study 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.
Primary Outcome
Composite endpoint of reduction from baseline in VAS back pain score by at least 20 mm, lack of device-related serious adverse events, absence of neurologic worsening and absence of surgical re-intervention. Note that the primary endpoint analysis is \*\*intent to treat\*\*, meaning that an outcome (success or failure) is assigned to all subjects randomized and treated. Subjects who withdrew early were deemed study failures.
Interventions
- DEVICE iFuse Implant System
- OTHER Non-surgical management
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2012-09 |
| Est. Completion | 2017-06 |
| Phase | NA |
What the finished NCT01681004 record still lists
NCT01681004 is an interventional study that assigns participants to a tested intervention. The registered 159 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which iFuse Implant System is the first listed.
NCT01681004 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01681004 about?
NCT01681004 is a clinical study titled "Investigation of Sacroiliac Fusion Treatment (INSITE)". 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 no...
What is the current status of trial NCT01681004?
This trial is currently completed. It is a NA study. The enrollment target is 159 participants. The study started on 2012-09. Estimated completion is 2017-06.
What interventions are being tested in trial NCT01681004?
The interventions under investigation include: iFuse Implant System (DEVICE), Non-surgical management (OTHER).
Who is sponsoring clinical trial NCT01681004?
This trial is sponsored by SI-BONE, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01681004's enrollment target sits among peer trials
159 654th of 2000 higher than 1,347 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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