Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
open fracture reduction · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| SoC | ACTIVE_COMPARATOR | Standard of Care |
| SoC plus 0.133 mg/mL | ACTIVE_COMPARATOR | - |
| SoC plus 0.4 mg/mL | ACTIVE_COMPARATOR | - |
| SoC plus 1.0 mg/mL | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| open fracture reduction | PROCEDURE | internal fracture fixation: osteosynthesis plates or intra-medullary nails |
Inclusion Criteria: Eligible patients must meet all of the following inclusion criteria: 1. patients with an acute open fracture of the tibial shaft secondary to trauma assessed by medical examination and current radiographs indicated for open fracture reduction and internal fixation using osteosy...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| CytoSorbents Corporation | CTSO | 1 | - | Undisclosed |
| Bone Biologics Corp. | BBLG | 1 | - | Undisclosed |
Open fracture reduction is a surgical procedure used in trauma care to realign and stabilize broken bones, particularly in open fractures where the bone has penetrated the skin. It is being studied as an adjunctive therapy for tibial shaft fractures, a type of leg fracture, to improve healing outcomes.
Open fracture reduction is being developed by Baxter International Inc., a medical products company traded on the New York Stock Exchange under the ticker BAX. The company is conducting clinical research on this procedure for trauma indications.
Open fracture reduction is in Phase 2 clinical development. It is an investigational procedure, not yet approved by regulatory authorities, and is being evaluated for safety and efficacy in treating tibial shaft fractures.
Open fracture reduction has one completed Phase 2 clinical trial, identified as NCT00533793, titled 'Adjunctive Therapy to Treat Tibial Shaft Fractures.' The trial enrolled 201 participants across multiple European countries and was completed, with no active trials currently ongoing.
Yes, the clinical trial for open fracture reduction, NCT00533793, was randomized and active-controlled. It was not double-blinded, meaning participants and investigators knew which treatment was administered, and it enrolled adult patients aged 18 years and older.