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.

Kuros Biosurgery AG45 sites in 9 countries208 target enrollmentNovember 2006

ConditionsTibia Plateau Fractures

InterventionsI-0401 (a new bone graft substitute)

DrugsI-0401 (a new bone graft substitute)

Overview

Phase: Phase 2
Intervention: I-0401 (a new bone graft substitute)
Conditions: Tibia Plateau Fractures
Sponsor: Kuros Biosurgery AG
Enrollment: 208
Locations: 45
Primary Endpoint: Radiographic Images
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 2006

End Date

September 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kuros Biosurgery AG

Responsible Party

Sponsor

Eligibility Criteria

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.