Tibial Fractures Treatment—Bone Support

Condition: Tibial Fractures

Eligibility

Key Inclusion Criteria

  • 18-21 years old with evidence of proximal and distal tibial physeal closure, OR 22-75 years old
  • Gustilo-Anderson Grade II, IIIA, or IIIB open tibial shaft fracture that can be fixed with an intramedullary nail (metal rod)
  • Bone loss at the fracture site must have a bone gap between 5 and 27.5 millimeters.

Key Exclusion Criteria

  • Pregnant or breastfeeding women, or planning to become pregnant
  • Currently participating in an investigational drug or other device study, or previously enrolled in this study
  • Renal failure or documented chronic kidney disease

Full Study Name

A Prospective, Randomized, Multi-Center Controlled Trial of CERAMENT G as Part of Surgical Repair of Open Diaphyseal Tibial Fractures (IRB no. 46007)

Summary

This study focuses on patients who have been diagnosed with open tibial fracture, and due to loss or gaps in the bones as a result of their leg fracture, bone grafts will be used to fill these spaces. The purpose of the study is to evaluate whether the treatment of open fractures of the central part of the tibia (long bone in the lower leg) with CERAMENT G is safer and more beneficial than the current standard surgical and medical care given to patients with open tibia fractures. CERAMENT G is intended to fill gaps in the bone to promote bone healing and, by supplying gentamicin (an antibiotic) directly to the bone and surrounding tissue for up to a month, help prevent infection. The use of CERAMENT G in this study is investigational.

Phase
Phase III


Principal Investigator

Charles Moon, MD

Contact