Safety and Efficacy of I 0401 in the Treatment of Tibial Plateau Fractures Requiring Grafting - Full Text View

Purpose

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
Tibia Plateau Fractures	Drug: I-0401 (a new bone graft substitute)	Phase II

MedlinePlus related topics:

Bone Grafts Fractures

U.S. FDA Resources

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.

Further study details as provided by Kuros Biosurgery AG:

Primary Outcome Measures:

Radiographic Images [ Time Frame: All Follow-Up Visits ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Clinical assessments of the fracture site [ Time Frame: All Follow-Up Visits ] [ Designated as safety issue: Yes ]
Blood parameters [ Time Frame: All Follow-Up Visits ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: At several Follow-Up visits ] [ Designated as safety issue: Yes ]
Questionnaires of Life [ Time Frame: All Follow-Up Visits ] [ Designated as safety issue: Yes ]
Pharmacoeconomic evaluation [ Time Frame: All Follow-Up Visits ] [ Designated as safety issue: Yes ]

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
1: Experimental Experimental - high dose	Drug: I-0401 (a new bone graft substitute) 1 time application
2: Experimental Experimental - low dose	Drug: I-0401 (a new bone graft substitute) 1 time application
3: Active Comparator Autograft	Drug: I-0401 (a new bone graft substitute) 1 time application

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409799

Contacts


Contact: Isabelle Arrighi, PhD	+41 44 200 5600	isabelle.arrighi@kuros.ch

Show 44 Study Locations

Sponsors and Collaborators

Kuros Biosurgery AG

Investigators


Principal Investigator:	Peter Messmer, MD	Zurich University Hospital, Zurich, Switzerland

More Information

Responsible Party:	Kuros Biosurgery ( Virginia Jamieson )
Study ID Numbers:	CS I-040101/02
First Received:	December 8, 2006
Last Updated:	July 4, 2008
ClinicalTrials.gov Identifier:	NCT00409799
Health Authority:	Switzerland: Ethikkommision; 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

Keywords provided by Kuros Biosurgery AG:

Bone graft substitute

Promotion of bone healing

Study placed in the following topic categories:

Signs and Symptoms

Fractures, Bone

Wounds and Injuries

Disorders of Environmental Origin

ClinicalTrials.gov processed this record on October 22, 2008

Sponsored by:	Kuros Biosurgery AG
Information provided by:	Kuros Biosurgery AG
ClinicalTrials.gov Identifier:	NCT00409799