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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00409799
Recruitment Status : Completed
First Posted : December 11, 2006
Last Update Posted : March 16, 2012
Sponsor:
Information provided by (Responsible Party):
Kuros Biosurgery AG

Brief 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.

Condition or disease Intervention/treatment Phase
Tibia Plateau Fractures Drug: I-0401 (a new bone graft substitute) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
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.
Study Start Date : November 2006
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00409799


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

Responsible Party: Kuros Biosurgery AG
ClinicalTrials.gov Identifier: NCT00409799     History of Changes
Other Study ID Numbers: CS I-040101/02
First Posted: December 11, 2006    Key Record Dates
Last Update Posted: March 16, 2012
Last Verified: March 2012

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

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries