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 75 years.
Subject signed informed consent form and is willing to participate in the follow-up visits.
Long bones of the lower extremity (including articular tibia plateau acute fracture).
Bones of the foot (including articular calcaneus acute fracture).
Subject with alcohol dependence syndrome or any history of substance abuse within the past year.
Pregnancy or breastfeeding.
Subject participates in another clinical trial.
Unstable mental condition or psychiatric concomitant disease.
Medical Inventi S.A.
Lead sponsor
KCRI
Collaborator