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

Kuros Biosciences

Status and phase: Completed; Phase 2

Conditions: Tibia Plateau Fractures

Treatments: Drug: I-0401 (a new bone graft substitute)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00409799

CS I-040101/02

Details and patient eligibility

About

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.

Enrollment: 208 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 3 patient groups

1

Experimental group

Description:

Experimental - high dose

Treatment:

Drug: I-0401 (a new bone graft substitute)

2

Experimental group

Description:

Experimental - low dose

Treatment:

Drug: I-0401 (a new bone graft substitute)

3

Active Comparator group

Description:

Autograft

Treatment:

Drug: I-0401 (a new bone graft substitute)