NCT00409799

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Kuros Biosurgery AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Tibia Plateau Fractures

Interventions

Type	Name	Description
DRUG	I-0401 (a new bone graft substitute)	1 time application

Timeline

• Start date: 2006-11-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2006-12-11
• Last updated: 2012-03-16

Locations

45 sites across 9 countries: Australia, France, Germany, Hungary, Italy, Poland, Spain, Switzerland, United Kingdom