Study Evaluating CERAMENT™|G in Open Diaphyseal Tibial Fractures

You may be eligible if

• 1. Male or female 18-21 years of age with radiographic evidence on plain x-rays of proximal and distal tibial physeal closure, OR male or female 22-75 years of age
• 2. Gustilo-Anderson Grade II, IIIA, or IIIB open tibial shaft fracture (with or without involvement of the tibial plateau or pilon/plafond) amenable to fixation with an intramedullary nail
• 3. Bone loss at the fracture site must have a radiographic apparent bone gap (RABG) between 3 and 27.5 millimeters.
• 4. Life expectancy of at least 1 year
• 5. Patient is willing to provide informed consent, is geographically stable and able to comply with the required follow up visits, testing schedule and medication regimen
• 6. Adequate soft tissue coverage at the fracture site (through primary closure or surgical reconstruction, including local and free soft tissue transfer)
• 7. Definitive wound closure within 14 days of the initial injury
• 8. Unilateral fracture, or, in the case of individually-qualifying bilateral open tibia fractures, the more severe of the bilateral fractures.
• Patients will be excluded if ANY of the following conditions apply:
• 1. Pregnant or breastfeeding women or planning on becoming pregnant during the investigational period
• 2. Patient is currently participating in an investigational drug or other device study or previously enrolled in this study
• 3. Renal failure or documented chronic kidney disease with serum creatinine ≥3.5 mg/L or being treated with dialysis
• 4. Known hypersensitivity to aminoglycoside antibiotics, calcium sulfate or calcium hydroxyapatite
• 5. Pre-existing calcium metabolism disorder
• 6. Uncontrolled diabetes mellitus (hemoglobin A1c levels \> 10%)
• 7. A current endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, hyperthyroidism, parathyroid hormone disorder, Ehler-Danlos syndrome, osteogenesis imperfecta)
• 8. Neuromuscular disorders such as myasthenia gravis or Parkinson's disease
• 9. Currently has untreated malignant neoplasm(s), or is currently undergoing radiation therapy or chemotherapy
• 10. Previous history of osteomyelitis in the index limb
• 11. Ipsilateral tibial plateau or pilon/plafond fractures requiring a reconstruction that interferes with or prohibits the use of an intramedullary nail to stabilize the tibial shaft fracture or, in the opinion of the investigator, the treatment and/or rehabilitation of such fracture(s) would substantially interfere with the treatment, rehabilitation or other requirements of open tibial shaft fractures enrolled under this protocol.
• 12. Other ipsilateral lower extremity fracture(s) if, in the opinion of the investigator, the treatment and/or rehabilitation of such fracture(s) will substantially interfere with the treatment, rehabilitation or other requirements outlined in this protocol.