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, measured radiographically by CT at 6 and 12 months. * Weight-bearing ability, assessed at 6 and 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
Emek Medical Center
Afula, Israel
RECRUITINGBarzilai Medical Center
Ashkelon, Israel
RECRUITINGHillel Yafe
Hadera, Israel
RECRUITINGPrimary 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.
Time frame: Throughout the post-intervention 12-month follow-up
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.
Time frame: Starting 4-week follow-up and through to the end of the 12-month follow-up
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).
Time frame: The test is performed at 3, 6 and 12 months post operation.
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Carmel Medical Center
Haifa, Israel
RECRUITINGRambam Health Campus
Haifa, Israel
RECRUITINGMeir Medical Center
Kfar Saba, Israel
RECRUITING