NCT02270203

LOIS: Long-Term Follow-Up in INSITE/SIFI

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 103 (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 long term safety and effectiveness of SI joint fusion using the iFuse Implant System in patients with degenerative sacroiliitis (DS) and/or sacroiliac joint disruptions (SD). Study Design: This study is extended follow-up from two ongoing multicenter prospective US clinical trials. All participants have already undergone the surgical procedure of interest (SI joint fusion with iFuse Implant System). The two ongoing trials are: * SIFI:( Sacroiliac Joint Fusion with iFuse Implant System) a single-arm trial of patients with degenerative sacroiliitis or sacroiliac joint disruption who underwent iFuse placement, and * INSITE(Investigation of Sacroiliac Fusion Treatment): a randomized clinical trial of the same patient population who underwent either non-surgical treatment or iFuse placement

Conditions

• Degenerative Sacroilitis
• Sacroiliac Joint Disruption

Interventions

Type	Name	Description
RADIATION	Pelvic CT at 5 years post-op	Pelvic CT at 5 years post-op

Timeline

• Start date: 2014-10-01
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2014-10-21
• Last updated: 2019-08-06

Locations

12 sites across 1 country: United States