Pelvic Fixation and Fusion During Multilevel Spinal Surgery
← catalyst calendarNCT05640908 · readout ≤ 468 d
Sponsored by SI-BONE, Inc. (industry) · SIBN — their whole pipeline →.
Phase
—
Status
Active, not recruiting
Study type
Observational
Enrollment
200estimated
Sites
9
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-06-05 | actual | When the study began enrolling |
| Primary completion | Nov 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2022-12-07 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-01-23 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Spinal Fusion
- Deformity of Spine
Intervention
- Device: iFuse Bedrock Granite Implant System — also filed as GRANITE, Bedrock Granite
Primary outcomes
what the primary-completion date above is the date OFPostoperative incidence of serious adverse events probably or definitely related to GRANITE
measured 2 years
Postoperative incidence of SI joint pain in subject without SI joint pain at baseline
measured 2 years
Postoperative incidence of L5-S1 pseudoarthrosis
measured 2 years
Postoperative incidence of pelvic construct failure
measured 2 years
Postoperative incidence of device failures related to GRANITE (e.g., rod disengagement, screw pullout)
measured 2 years
Radiographic
measured 12 month and 24 months
Change in Quality of Life PROs
measured 6 month, 12 month and 24 months
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