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Sponsored by: |
Kuros Biosurgery AG |
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Information provided by: | Kuros Biosurgery AG |
ClinicalTrials.gov Identifier: | NCT00409799 |
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.
Condition | Intervention | Phase |
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Tibia Plateau Fractures |
Drug: I-0401 (a new bone graft substitute) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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. |
Estimated Enrollment: | 180 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | September 2011 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Experimental - high dose
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Drug: I-0401 (a new bone graft substitute)
1 time application
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2: Experimental
Experimental - low dose
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Drug: I-0401 (a new bone graft substitute)
1 time application
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3: Active Comparator
Autograft
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Drug: I-0401 (a new bone graft substitute)
1 time application
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Peter Messmer, MD | Zurich University Hospital, Zurich, Switzerland |
Responsible Party: | Kuros Biosurgery ( Virginia Jamieson ) |
Study ID Numbers: | CS I-040101/02 |
Study First Received: | December 8, 2006 |
Last Updated: | May 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00409799 History of Changes |
Health Authority: | Switzerland: Ethikkommission; Switzerland: Swissmedic; United States: Institutional Review Board; United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Spain: Ministry of Health and Consumption; Italy: The Italian Medicines Agency |
Bone graft substitute Promotion of bone healing |
Signs and Symptoms Fractures, Bone Wounds and Injuries Disorders of Environmental Origin |
Fractures, Bone Wounds and Injuries Disorders of Environmental Origin |