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
Long and short bones extra articular comminuted fracture or
Long and short bones extra and intra articular defect/gap or non union, incapable of self-regeneration
Age is under 18 or above 80
A simple fracture manageable by one definitive treatment
Pregnant or lactating women
Patients with active infection that is in question and needs osteogenic treatment.
Single group
BonoFill-II
Biological/VaccineSurgery will be performed under local or general anesthetics according to the Investigator's and anesthesiologist discretion. A standard orthopedic approach will be made according to the fracture site.Then the transplantation of BonoFill-II into the fracture site and the fixation of the fracture by intramedullary nail or plate and screws or external fixator as required will be performed. internal fixation (plate and screws and intramedullary nails) will not be routinely removed. External fixators will be removed upon achievement of satisfactory bone union.
Primary safety endpoint: Absence of treatment-emergent appearance of safety issues
Subjects demonstrating no appearance of heterotrophic bone ossification, excessive bone formation and/or any abnormalities in the treated site, in the proximal or distal joint by visual examination of the transplantation site and by X-ray and/or CT.
Efficacy endpoint: Bone continuity
Bone union, as assessed by X-ray and CT. CT scans are performed 6 and 12 months post operation, to verify bone regeneration and complete bone continuity was achieved.
Functional efficacy endpoint: Weight bearing ability
clinical examination of weight bearing ability for lower extremities or coffee-cup weight bearing ability for upper extremities. The physician assesses the functionality of the operated limb, by testing the patients ability to bear their weight when standing (in case of lower limb bone defect) or by coffee cup holding simulation (in case of upper limb bone defect).
Lack of pain at the surgical site
Pain at the surgical site will be evaluated using a VAS pain scale, this assessment will be used in cases of bone defect where weight-bearing is not applicable due to further limb injuries (such as nerve injuries or other non-bone defects).
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