Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic CT at 5 years post-op | Radiation | Pelvic CT at 5 years post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Success | 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). | 3 years on LOIS (5 years post-op) |
| Radiographic (CT) apposition of bone to sacral and iliac sides of implant | 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. | 3 years on LOIS (5 years post-op) |
| Measure | Description | Time Frame |
|---|---|---|
| VAS (Visual Analog Scale) | Improvement in VAS (Visual Analog Scale), SI joint pain at follow-up visits. | 3 years on LOIS (5 years post-op) |
| Oswestry Disability Index (ODI) Questionnaire | Improvement in Oswestry Disability Index (ODI) at follow-up visits. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Subjects with degenerative sacroiliitis or sacroiliac joint disruption who underwent iFuse placement.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel Cher, MD | SI-BONE, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States | ||
| Regenerative Orthopaedics and Spine Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30214322 | Derived | Darr E, Cher D. Four-year outcomes after minimally invasive transiliac sacroiliac joint fusion with triangular titanium implants. Med Devices (Auckl). 2018 Aug 29;11:287-289. doi: 10.2147/MDER.S179003. eCollection 2018. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 3 years on LOIS (5 years post-op) |
| Improvement in quality of life (QOL) | Improvement in quality of life as measure by EQ-5D Questionnaire at follow-up visits. | 3 years on LOIS (5 years post-op) |
| non-working subjects returning to work | Proportion of non-working subjects who return to work | 3 years on LOIS (5 years post-op) |
| CT scans showing bridging bone | Proportion of CT scans that show bridging bone across the SI joint at 5 years post-operatively | 3 years on LOIS (5 years post-op) |
| SAE (Serious Adverse Events) occurrence rate | Occurrence rate of serious adverse events. | 3 years on LOIS |
| Stockbridge |
| Georgia |
| 30281 |
| United States |
| Orthopaedic Center of Southern Illinois | Mount Vernon | Illinois | 62864 | United States |
| Bluegrass Orthopaedics & Hand Care | Lexington | Kentucky | 40509 | United States |
| Columbia Orthopaedic Group | Columbia | Missouri | 65201 | United States |
| Oklahoma Center for Spine & Pain Solutions | Oklahoma City | Oklahoma | 73159 | United States |
| Allegheny Medical Center | Pittsburgh | Pennsylvania | 15212 | United States |
| MUSC | Charleston | South Carolina | 29425 | United States |
| Precision Spine Care | Tyler | Texas | 75701 | United States |
| Overlake Hospital Medical Center | Bellevue | Washington | 98004 | United States |
| Aurora Research Institute | Green Bay | Wisconsin | 54311 | United States |
| Integrated Spine Care | Wauwatosa | Wisconsin | 53132 | United States |