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