Last updated on February 2018

Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II


Brief description of study

The purpose of this clinical study is to evaluate the safety and the efficacy of BonoFill-II as an autologous bone-regenerating graft in the reconstruction of deficient bone in two clinical indications:

  1. Long bone extra-articular comminuted fracture
  2. Large bone defect or gap incapable of self-regeneration

Detailed Study Description

Primary Endpoint:

To establish that the transplantation of BonoFill-II into bone defect/gap is safe under the following conditions:

  • No treatment-related appearance of heterotrophic bone ossification
  • No excessive bone formation at the transplantation sites
  • No abnormalities in the treated sites

Secondary Endpoint:

To establish that the transplantation of BonoFill-II into bone defect/gap is effective under the following conditions:

  1. Long bone extraarticular comminuted fracture:
    • Enhancement of fracture healing is considerably faster than the common time period known for these clinical conditions in at least two thirds of the treated subjects.
  2. Large bone defect or gap incapable of self-regeneration:
    • A newly formed bone tissue is generated within the bone gap which re-establishes bone continuity in at least two thirds of the treated subjects.

Clinical Study Identifier: NCT03024008

Contact Investigators or Research Sites near you

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Nimrod Rozen, MD, PhD

Emek Medical Center
`Afula, Israel
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