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

NCT00409799 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2012-03-16

No results posted yet for this study

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

DRUG

I-0401 (a new bone graft substitute)

1 time application

Sponsors & Collaborators

  • Kuros Biosurgery AG

    lead INDUSTRY

Principal Investigators

  • Peter Messmer, MD · Zurich University Hospital, Zurich, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • Australia
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00409799 on ClinicalTrials.gov