SI-BONE, Inc. (SIBN)
SI-BONE, Inc. is a medical technology company that develops and markets specialized implantable solutions for musculoskeletal conditions affecting the sacropelvic region. These devices are utilized across the United States and internationally. Its flagship product, iFuse, is a minimally invasive surgical implant system designed to address a range of indications, including sacroiliac joint dysfunction and degeneration, adult spinal deformities, and traumatic fractures of the pelvic ring. Beyond iFuse, the company offers advanced iterations like iFuse-3D. This titanium implant retains the distinctive triangular cross-section of the original iFuse but incorporates a proprietary 3D-printed porous surface and a fenestrated design. Another offering is iFuse-TORQ, a series of 3D-printed threaded implants. These are specifically engineered for treating pelvic fractures and facilitating minimally invasive sacroiliac joint fusion procedures. SI-BONE distributes its products primarily through a dedicated direct sales force, complemented by a network of independent distributors. Established in 2008, the company maintains its corporate headquarters in Santa Clara, California.
Sector: Surgical & Medical Instruments & Apparatus
Industry: Medical - Devices
SI-BONE, Inc.
Trials need funding. See this company's dilution risk and cash position.
- Phase 4Terminated
Validity and Reliability of Diagnostic Findings of SI Joint Blocking
0.75% bupivacaine, .75% bupivacaine
SI Joint Pain
NCT01874236Enrollment28StartApr 2013Primary CompletionSep 2014CompletionSep 2014 - Phase 4Active, not recruiting
iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction
Use of iFuse TORQ
Sacroiliac Joint Dysfunction, Sacroiliac; Fusion +2
NCT05870488Enrollment110StartMay 2023Primary CompletionApr 2025CompletionNov 2027est. - ObservationalCompleted
Sacroiliac Joint Fusion With iFuse Implant System (SIFI)
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Degenerative Sacroiliitis, Sacroiliac Joint Disruption
NCT01640353Enrollment194StartJul 2012Primary CompletionJan 2015CompletionFeb 2016 - Not applicableCompleted
Investigation of Sacroiliac Fusion Treatment (INSITE)
iFuse Implant System, Non-surgical management
Degenerative Sacroiliitis, Sacroiliac Joint Disruption
NCT01681004Enrollment159StartSep 2012Primary CompletionFeb 2015CompletionJun 2017 - Not applicableCompleted
iFuse Implant System® Minimally Invasive Arthrodesis
iFuse Implant System, Conservative Management
Sacroiliac Joint Pain
NCT01741025Enrollment103StartJun 2013Primary CompletionDec 2015CompletionSep 2017 - ObservationalCompleted
LOIS: Long-Term Follow-Up in INSITE/SIFI
Pelvic CT at 5 years post-op
Degenerative Sacroilitis, Sacroiliac Joint Disruption
NCT02270203Enrollment103StartOct 2014Primary CompletionJul 2019CompletionJul 2019 - Not applicableCompleted
Study of Bone Growth in the Sacroiliac Joint After Minimally Invasive Surgery With Titanium Implants
SIJ fusion with iFuse-3D
Sacroiliac Dysfunction
NCT03122899Enrollment51StartOct 2017Primary CompletionJun 2024CompletionJun 2024 - Not applicableCompleted
SI Joint Stabilization in Long Fusion to the Pelvis
iFuse 3-D in Bedrock Configuration, Multilevel Lumbar Fusion surgery
Sacroiliac Joint Disruption, Scoliosis Lumbar Region
NCT04062630Enrollment213StartMay 2020Primary CompletionDec 2024CompletionJan 2025 - Not applicableTerminated
Sacral Fracture Fusion/Fixation for Rapid Rehabilitation
Surgical Intervention, Non-Surgical Management
Fracture;Pelvis, Sacral Fracture +4
NCT05426356Enrollment28StartSep 2022Primary CompletionJun 2024CompletionJun 2024 - ObservationalActive, not recruiting
Pelvic Fixation and Fusion During Multilevel Spinal Surgery
iFuse Bedrock Granite Implant System
Spinal Fusion, Deformity of Spine
NCT05640908Enrollment200StartJun 2023Primary CompletionNov 2027est.CompletionDec 2027est. - ObservationalActive, not recruiting
Innovative Spinopelvic Solutions With Real-World Evidence
Health questionnaires
Sacroiliac Joint Dysfunction, Sacroiliac Joint Pain
NCT06706908Enrollment1,000StartDec 2024Primary CompletionDec 2034est.CompletionDec 2034est. - ObservationalRecruiting
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
iFuse TORQ TNT Implant System
Fracture; Pelvic, Insufficiency Fractures +4
NCT07530497Enrollment120StartAug 2026est.Primary CompletionFeb 2028est.CompletionAug 2028est. - ObservationalNot yet recruiting
Posterior-Inferior Intra-articular Cortical Piercing Titanium Implant for Sacroiliac Joint Fusion: Evaluation of Safety and Effectiveness Outcomes
iFuse INTRA Ti Implant System
Sacro Iliac Joint Pain, Sacro-iliac Joints +4
NCT07565545Enrollment120StartSep 2026est.Primary CompletionMar 2028est.CompletionSep 2029est.
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 4 | Terminated | 0.75% bupivacaine, .75% bupivacaine | NCT01874236 |
| Phase 4 | Active, not recruiting | Use of iFuse TORQ | NCT05870488 |
| Observational | Completed | - | NCT01640353 |
| Not applicable | Completed | iFuse Implant System, Non-surgical management | NCT01681004 |
| Not applicable | Completed | iFuse Implant System, Conservative Management | NCT01741025 |
| Observational | Completed | Pelvic CT at 5 years post-op | NCT02270203 |
| Not applicable | Completed | SIJ fusion with iFuse-3D | NCT03122899 |
| Not applicable | Completed | iFuse 3-D in Bedrock Configuration, Multilevel Lumbar Fusion surgery | NCT04062630 |
| Not applicable | Terminated | Surgical Intervention, Non-Surgical Management | NCT05426356 |
| Observational | Active, not recruiting | iFuse Bedrock Granite Implant System | NCT05640908 |
| Observational | Active, not recruiting | Health questionnaires | NCT06706908 |
| Observational | Recruiting | iFuse TORQ TNT Implant System | NCT07530497 |
| Observational | Not yet recruiting | iFuse INTRA Ti Implant System | NCT07565545 |