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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational



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

Brief 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