Overview
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:
- Long and short bone extra-articular comminuted fracture
- Long and short bones extra and intra articular defect /Gap or non-union, incapable of self-regeneration
Description
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.
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- More than 3 previous failed interventions at the surgical site
- History of advanced congestive heart failure or active acute myocardial infarction (AMI), renal failure (estimated GFR of <30 ml/min/1.73 m2 at screening), or hepatic disease (hepatic insufficiency classified as Child-Pugh B or C)
- Diabetic subjects (HbA1c > 8)
- Subject treated currently with systemic steroids.
- Subjects with known autoimmune diseases, such as Addison's disease, Celiac disease - sprue (gluten-sensitive enteropathy), Dermatomyositis, Graves disease, Hashimoto's thyroiditis, Multiple sclerosis, Myasthenia gravis, Pernicious anemia, Reactive arthritis, Rheumatoid arthritis, Sjogren syndrome, Systemic lupus erythematosus.
- Subjects diagnosed with osteoporosis
- Chronic severe PVD (Peripheral Vascular Disease) subjects
- Post major vascular operation in the treated limb/s and above the surgical site (with or without Gore-Tex grafting)
- Subjects that have a known scar healing problem (keloid formation).
- Subjects treated with Bisphosphonate drugs
- Oncology patient or subjects who received chemotherapy or radiotherapy treatment in the past 12 months
- Immunocompromised condition from any reason, at screening
- Subjects participating in another clinical trial 30 days prior to and during the study period.
- Drug addicts and psychiatric patients patients incapable of giving consent.
- Subjects with a known history of any significant medical disorder, which in the investigator's judgment contraindicates the subject's participation
- Subjects with any known allergy for local/general anesthesia
- Positive serology for either HIV, hepatitis B or hepatitis C
- Abnormal clinically significant laboratory test and findings, as per the investigator's judgment