Safety and Efficacy of I 0401 in the Treatment of Tibial Plateau Fractures Requiring Grafting

A Phase 2 Randomized, Controlled, Open-label (Dose-blinded), Multi-center, Dose-finding Study of the Safety and Efficacy of I-0401 in the Treatment of Patients With Fractures of the Tibial Plateau Requiring Grafting.

For certain tibial plateau fractures the bone is compressed due to the force acting on the tibia during the accident. The void provoked by the compression of the bone is filled with an appropriate filling material and the fracture is fixated. I 0401 is a new bone graft substitute that has shown capacities to promote bone-healing. This study will test the safety and efficacy of I 0401 in the treatment of patients with tibial plateau fractures requiring grafting.

Inclusion Criteria:

• Radiological evidence of a tibial plateau fracture requiring grafting
• Females of child-bearing potential must be willing to undergo a pregnancy test (urine) prior to treatment start (at screening).

Exclusion Criteria:

• Concomitant ipsilateral fractures of the limb other than the fracture of the tibial plateau.
• Active or past history of malignant tumor.
• Evidence of systemic or localized infection at time of surgery.
• Pregnant or lactating females.