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

Phase 2 Completed 208 enrolled Kuros Biosurgery AG

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2006-11
Primary completion: 2011-09
Completion: 2011-09

Publications

Smith TO, Casey L, McNamara IR, Hing CB. Surgical fixation methods for tibial plateau fractures. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD009679. doi: 10.1002/14651858.CD009679.pub3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	I-0401	Unknown	—	—

Indications

No indication recorded.