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


Detailed Summary:
Sponsor: SI-BONE, Inc.

Current Primary Outcome:

  • VAS (Visual Analog Scale) [ Time Frame: 3 years on LOIS (5 years post-op) ]
    improvement in VAS (Visual Analog Scale), Sacroiliac (SI) joint joint pain by ≥20 mm
  • Absence of device-related SAE (Serious Adverse Events) [ Time Frame: 3 years on LOIS (5 years post-op) ]
    Absence of device-related SAE (Serious Adverse Events)
  • Absence of neurological worsening [ Time Frame: 3 years on LOIS (5 years post-op) ]
    Absence of neurological worsening.
  • Absence of surgical re-intervention on the target SI joint [ Time Frame: 3 years on LOIS (5 years post-op) ]
    Absence of surgical re-intervention on the target SI joint(s)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • VAS (Visual Analog Scale) [ Time Frame: 3 years on LOIS ]
    Improvement in VAS (Visual Analog Scale), SI joint pain at follow-up visits.
  • Oswestry Disability Index (ODI) Questionnaire [ Time Frame: 3 years on LOIS ]
    Improvement in Oswestry Disability Index (ODI) at follow-up visits.
  • Improvement in quality of life (QOL) [ Time Frame: 3 years on LOIS ]
    Improvement in quality of life as measure by EQ-5D Questionnaire at follow-up visits.
  • non-working subjects returning to work [ Time Frame: 3 years on LOIS ]
    Proportion of non-working subjects who return to work
  • CT scans showing bridging bone [ Time Frame: 3 years on LOIS (5 years post-op) ]
    Proportion of CT scans that show bridging bone across the SI joint at 5 years post-operatively
  • SAE (Serious Adverse Events) occurrence rate [ Time Frame: 3 years on LOIS ]
    Occurrence rate of serious adverse events.


Original Secondary Outcome: Same as current

Information By: SI-BONE, Inc.

Dates:
Date Received: October 16, 2014
Date Started: October 2014
Date Completion: January 2019
Last Updated: August 23, 2016
Last Verified: August 2016