Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01097486 | Safety and Preliminary Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy | PHASE2 | COMPLETED | 24 | — | — | Jun 1, 2010 | Jul 1, 2014 | Aug 16, 2019 | 8 | United States |
| NCT01106417 | Safety and Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy and Fusion | PHASE1 | COMPLETED | 12 | — | — | Jun 1, 2010 | Mar 1, 2013 | Jun 29, 2020 | 2 | Australia |
To determine the safety of NeoFuse using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests (hematology, serum chemistry, inflammation, and and immunology).
| Arm | Type | Description |
|---|---|---|
| Allograft | ACTIVE_COMPARATOR | Cervical Spinal Fusion with Allograft |
| NeoFuse | EXPERIMENTAL | Cervical Spinal Fusion with NeoFuse |
| MasterGraft Granules | ACTIVE_COMPARATOR | Anterior Cervical Discectomy and Fusion with MasterGraft Granules MASTERGRAFT® GRANULES are a medical-grade, polyporous resorbable ceramic hybrid composed of 15% hydroxyapatite (HA) and 85% beta-tricalcium phosphate (β-TCP). The combination of these natural bone materials provides surgeons with an osteoconductive, porous implant that improves osteointegration by allowing cells to colonize throughout the implant and optimize the bone healing process |
| Name | Type | Description |
|---|---|---|
| NeoFuse | BIOLOGICAL | Single Dose NeoFuse Surgical Implantation |
| Allograft | PROCEDURE | Single Dose Allograft Surgical Implantation |
| MasterGraft Granules | DEVICE | Single Dose MaterGraft Granules Surgical Implantation |
Inclusion Criteria: 1. Male or females between 18 and 70 years of age, inclusive. 2. Has the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol. 3. Has the ability to understand and provide written authorization for the us...