Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kuros Biosurgery AG
ClinicalTrials.gov Identifier:
NCT00409799
First received: December 8, 2006
Last updated: March 15, 2012
Last verified: March 2012
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 208
Study Start Date: November 2006
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Experimental - high dose
 Drug: I-0401 (a new bone graft substitute)
1 time application
Experimental: 2
Experimental - low dose
 Drug: I-0401 (a new bone graft substitute)
1 time application
Active Comparator: 3
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

  Show 45 Study Locations
Sponsors and Collaborators
Kuros Biosurgery AG
Investigators
Principal Investigator: Peter Messmer, MD Zurich University Hospital, Zurich, Switzerland
  More Information

No publications provided

Responsible Party: Kuros Biosurgery AG
ClinicalTrials.gov Identifier: NCT00409799     History of Changes
Other Study ID Numbers: CS I-040101/02
Study First Received: December 8, 2006
Last Updated: March 15, 2012
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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on June 18, 2013