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Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II
Sponsor: BonusBio Group Ltd
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
Official title: A Multicenter Study to Evaluate the Enhancement of Bone Regeneration and Healing in the Extremities by the Use of Autologous BonoFill-II
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2017-07-27
Completion Date
2027-06
Last Updated
2025-12-10
Healthy Volunteers
No
Conditions
Interventions
BonoFill-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.
Locations (6)
Emek Medical Center
Afula, Israel
Barzilai Medical Center
Ashkelon, Israel
Hillel Yafe
Hadera, Israel
Carmel Medical Center
Haifa, Israel
Rambam Health Campus
Haifa, Israel
Meir Medical Center
Kfar Saba, Israel