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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
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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Emek Medical Center
Not yet recruiting
BonusBio Group Ltd
Published on BioPortfolio: 2017-01-19T06:38:21-0500
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