Bone Fracture Clinical Trial
Official title:
A Multicenter Study to Evaluate the Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II
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 and short bone extra-articular comminuted fracture 2. Long and short bones extra and intra articular defect /Gap or non-union, incapable of self-regeneration
Primary Endpoint: Safety: 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 Efficacy: to establish that the transplantation of BonoFill-II into bone defect/gap is effective under the following conditions: Bone continuity rate, measured radiographically by CT at 6 and 12 months. ;
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