LOIS: Long-Term Follow-Up in INSITE/SIFI (LOIS)
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
|Degenerative Sacroilitis Sacroiliac Joint Disruption||Radiation: Pelvic CT at 5 years post-op|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||LOIS: Long-Term Follow-Up in INSITE/SIFI|
- Subject Success [ Time Frame: 3 years on LOIS (5 years post-op) ]Composite endpoint of success defined as improvement in VAS (Visual Analog Scale) recorded at SIFI or INSITE Baseline VAS back pain score by ≥20 mm; Absence of device-related SAE (Serious Adverse Events) ; Absence of neurological worsening related to the sacral spine,& Absence of surgical re-intervention on the target SI joint(s).
- Radiographic (CT) apposition of bone to sacral and iliac sides of implant [ Time Frame: 3 years on LOIS (5 years post-op) ]Proportion of subjects (with CT) who had at least 30% apposition of bone to sacral and iliac sides in at least 2 of 3 iFuse implants.
- VAS (Visual Analog Scale) [ Time Frame: 3 years on LOIS (5 years post-op) ]Improvement in VAS (Visual Analog Scale), SI joint pain at follow-up visits.
- Oswestry Disability Index (ODI) Questionnaire [ Time Frame: 3 years on LOIS (5 years post-op) ]Improvement in Oswestry Disability Index (ODI) at follow-up visits.
- Improvement in quality of life (QOL) [ Time Frame: 3 years on LOIS (5 years post-op) ]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 (5 years post-op) ]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.
|Study Start Date:||October 2014|
|Estimated Study Completion Date:||December 2019|
|Estimated Primary Completion Date:||December 2019 (Final data collection date for primary outcome measure)|
Radiation: Pelvic CT at 5 years post-op
Please refer to this study by its ClinicalTrials.gov identifier: NCT02270203
|United States, Connecticut|
|Yale University School of Medicine|
|New Haven, Connecticut, United States, 06510|
|United States, Georgia|
|Regenerative Orthopaedics and Spine Institute|
|Stockbridge, Georgia, United States, 30281|
|United States, Illinois|
|Orthopaedic Center of Southern Illinois|
|Mount Vernon, Illinois, United States, 62864|
|United States, Kentucky|
|Bluegrass Orthopaedics & Hand Care|
|Lexington, Kentucky, United States, 40509|
|United States, Missouri|
|Columbia Orthopaedic Group|
|Columbia, Missouri, United States, 65201|
|United States, Oklahoma|
|Orthopedic and Reconstructive Center|
|Oklahoma City, Oklahoma, United States, 73109|
|United States, Pennsylvania|
|Allegheny General Hospital|
|Pittsburgh, Pennsylvania, United States, 15212|
|United States, South Carolina|
|Charleston, South Carolina, United States, 29425|
|United States, Texas|
|Precision Spine Care|
|Tyler, Texas, United States, 75701|
|United States, Washington|
|Overlake Hospital Medical Center|
|Bellevue, Washington, United States, 98004|
|United States, Wisconsin|
|Aurora Research Institute|
|Green Bay, Wisconsin, United States, 54311|
|Integrated Spine Care|
|Wauwatosa, Wisconsin, United States, 53132|
|Study Director:||Daniel Cher, MD||SI-BONE, Inc.|