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

• Clinical assessments of the fracture site [ Time Frame: All Follow-Up Visits ] [ Designated as safety issue: Yes ]
• Blood parameters [ Time Frame: All Follow-Up Visits ] [ Designated as safety issue: Yes ]
• Vital signs [ Time Frame: At several Follow-Up visits ] [ Designated as safety issue: Yes ]
• Questionnaires of Life [ Time Frame: All Follow-Up Visits ] [ Designated as safety issue: Yes ]
• Pharmacoeconomic evaluation [ Time Frame: All Follow-Up Visits ] [ Designated as safety issue: Yes ]

• Clinical assessments of the fracture site
• Blood parameters
• Vital signs
• Questionnaires of Life
• Pharmacoeconomic evaluation

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.

• Experimental: 1
  Experimental - high dose
  Intervention: Drug: I-0401 (a new bone graft substitute)
• Experimental: 2
  Experimental - low dose
  Intervention: Drug: I-0401 (a new bone graft substitute)
• Active Comparator: 3
  Autograft
  Intervention: Drug: I-0401 (a new bone graft substitute)

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.