A Prospective, Randomized, Double-blinded, Single-center, Non-inferiority Study Evaluating the Efficacy, Safety and Long-term (Radiological and Clinical) Outcomes During Comprehensive Care Continuum of Implanted Biocomposite for Bone Regeneration FlexiOss® Compared to the Current Standard of Care in Patients With Primary Acute Trauma Bone Defects.
The aim of this clinical study is to evaluate the efficacy, safety and long-term (radiological and clinical) outcomes during comprehensive care continuum of implanted biocomposite for bone regeneration FlexiOss® compared to the current standard of care in patients with primary acute trauma bone defects. The efficacy, safety and long-term (radiological and clinical) evaluation will be assessed during follow up visits at 2, 6 weeks, 3, 6, 12 and 24 months.
• Age between 18 and 70 years.
• Subject signed informed consent form and is willing to participate in the follow-up visits.
• Subject with an existing acute primary bone defect in one of the following groups:
‣ Long bones of the lower extremity (including articular tibia plateau acute fracture).
⁃ Bones of the foot (including articular calcaneus acute fracture).
• Subject scheduled for orthopedic procedure with bone substitute material.
• Subject with bone defects volume that can be completely filled using a maximum of the one largest FlexiOss® fitting.