NCT01640353

Sacroiliac Joint Fusion With iFuse Implant System (SIFI)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 194 (actual)
• Sponsor: SI-BONE, Inc. · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2012-07-01
• Primary completion: 2015-01-01
• Completion: 2016-02-01
• First posted: 2012-07-13
• Last updated: 2017-03-24
• Results posted: 2017-03-24

Locations

26 sites across 1 country: United States