Bone Fracture
Conditions
Keywords
Critical Gap, Comminuted Fracture, Extra-Articular
Brief summary
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
Detailed 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, measured radiographically by CT at 6 and 12 months. * Weight-bearing ability, assessed at 6 and 12 months.
Interventions
BIOLOGICALBonoFill-II
Surgery 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.
Sponsors
BonusBio Group Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary safety endpoint: Absence of treatment-emergent appearance of safety issues | Throughout the post-intervention 12-month follow-up | 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 | Starting 4-week follow-up and through to the end of the 12-month follow-up | 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 | The test is performed at 3, 6 and 12 months post operation. | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Lack of pain at the surgical site | 3, 6 and 12 months | 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). |
Countries
Israel
Contacts
Primary ContactNimrod Rozen, MD, PhD
Backup ContactVered Kivity, PhD, MBA
Outcome results
None listed