Clinical Trial

FlexiOss® - Efficacy, Safety and Long-term (Radiological and Clinical) Outcomes During Comprehensive Care Continuum of Implanted Biocomposite for Bone Regeneration.

Study acronym: FlexiOssOT
Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-29.
Trial Details
NCT Number NCT07209033
Lead Sponsor Medical Inventi S.A.
Collaborators: KCRI
Conditions Bone Defect
Enrollment 80 participants
Start Date 2025-05-29
Primary Completion 2028-03 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-02-12