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

This study has been completed.
Information provided by (Responsible Party):
Kuros Biosurgery AG Identifier:
First received: December 8, 2006
Last updated: March 15, 2012
Last verified: March 2012
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
Intervention Model: Parallel Assignment
Masking: None (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:

Further study details as provided by Kuros Biosurgery AG:

Primary Outcome Measures:
  • Radiographic Images [ Time Frame: All Follow-Up Visits ]

Secondary Outcome Measures:
  • Clinical assessments of the fracture site [ Time Frame: All Follow-Up Visits ]
  • Blood parameters [ Time Frame: All Follow-Up Visits ]
  • Vital signs [ Time Frame: At several Follow-Up visits ]
  • Questionnaires of Life [ Time Frame: All Follow-Up Visits ]
  • Pharmacoeconomic evaluation [ Time Frame: All Follow-Up Visits ]

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00409799

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

Responsible Party: Kuros Biosurgery AG Identifier: NCT00409799     History of Changes
Other Study ID Numbers: CS I-040101/02
Study First Received: December 8, 2006
Last Updated: March 15, 2012

Keywords provided by Kuros Biosurgery AG:
Bone graft substitute
Promotion of bone healing

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries processed this record on August 17, 2017