FlexiOss® - Efficacy, Safety and Long-term (Radiological and Clinical) Outcomes During Comprehensive Care Continuum of Implanted Biocomposite for Bone Regeneration.
A Prospective, Randomized, Double-blinded, Multi-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.
Medical Inventi S.A.
80 participants
May 29, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
Bone reconstruction with FlexiOss® biocomposite.
Implantation of allogenic human bone graft.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07209033