Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01640353 · ClinicalTrials.gov registry record
Sacroiliac Joint Fusion With iFuse Implant System (SIFI)
A clinical trial, sponsored by SI-BONE.
- Completed
- Registry status
- 194
- Enrollment target
NCT01640353: Completed study, sponsored by SI-BONE.
NCT01640353 is a clinical trial that has completed, run by SI-BONE. The registered enrollment target is 194 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01640353 has completed, sponsored by SI-BONE.
- COMPLETED
- Registry status
- 194 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the use of the iFuse Implant System to treat degenerative sacroiliitis (arthritis of the SI joint) and sacroiliac disruption (abnormal separation or tearing of the sacroiliac joint). The iFuse Implant System (iFuse device) is a medical device that is surgically implanted into the sacroiliac (SI) joint during a minimally invasive surgical procedure (one that uses a smaller incision and less damage to the skin and other tissues than standard surgery). The purpose of implanting the device is to stabilize and fuse 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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2012-07 |
| Est. Completion | 2016-02 |
What the finished NCT01640353 record still lists
NCT01640353 is an observational study that tracks outcomes without assigning an intervention. The registered 194 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01640353 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01640353 about?
NCT01640353 is a clinical study titled "Sacroiliac Joint Fusion With iFuse Implant System (SIFI)". The purpose of this study is to evaluate the use of the iFuse Implant System to treat degenerative sacroiliitis (arthritis of the SI joint) and sacroiliac disruption (abnormal separation or tearing of the sacroiliac joint). The iFuse Implant System (iFuse device) is a medical device that is surgical...
What is the current status of trial NCT01640353?
This trial is currently completed. The enrollment target is 194 participants. The study started on 2012-07. Estimated completion is 2016-02.
Who is sponsoring clinical trial NCT01640353?
This trial is sponsored by SI-BONE, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03593759 · 194 participants · Phase 3
Cardiac Sarcoidosis Randomized Trial
- NCT05053152 · 194 participants · Phase 2
Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study
- NCT05156112 · 194 participants · NA
OSA PAP Treatment for Veterans With SUD and PTSD on Residential Treatment Unit
- NCT05351424 · 194 participants · NA
AVI Didactic Experience for Latinx Patient Treatment Adherence and Non-English Speaker Trial Enrollment Study in Rad Onc
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia