Sacroiliac Joint Fusion With iFuse Implant System (SIFI)

NCT01640353 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 194

Last updated 2017-03-24

Study results available
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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.

Conditions

  • Degenerative Sacroiliitis
  • Sacroiliac Joint Disruption

Sponsors & Collaborators

  • SI-BONE, Inc.

    lead INDUSTRY

Principal Investigators

  • Bradley Duhon, MD · University of Colorado, Denver

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-01-31
Completion
2016-02-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01640353 on ClinicalTrials.gov