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

Sacroiliac Joint Disruption Clinical Trial

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

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02270203
Study type Observational
Source SI-BONE, Inc.
Contact
Status Completed
Phase
Start date October 2014
Completion date July 2019
View Details
See also
  Status Clinical Trial Phase
Completed NCT01681004 - Investigation of Sacroiliac Fusion Treatment (INSITE) N/A
Recruiting NCT05633888 - Post-Market Feasibility Study of the Tenon Medical CATAMARAN™ SI Joint Fusion System N/A
Enrolling by invitation NCT05628142 - Tenon Medical CATAMARAN™ SI Joint Fusion System CT Scan Study N/A
Active, not recruiting NCT04062630 - SI Joint Stabilization in Long Fusion to the Pelvis N/A
Active, not recruiting NCT01640353 - Sacroiliac Joint Fusion With iFuse Implant System (SIFI) Phase 4