Status:
RECRUITING
FlexiOss® - Efficacy, Safety and Long-term (Radiological and Clinical) Outcomes During Comprehensive Care Continuum of Implanted Biocomposite for Bone Regeneration.
Lead Sponsor:
Medical Inventi S.A.
Collaborating Sponsors:
KCRI
Conditions:
Bone Defect
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 regeneratio...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Diagnosed severe degenerative, metabolic bone disease or any condition that in opinion of the Investigator could adversely affect bone healing and regeneration.
- Subject with known allergies or hypersensitivity to any components of the FlexiOss® biocomposite material
- Subject with active cancer disease and/or during related oncological treatment.
- Contraindications for computed tomography angiography according to the site Standard of Care include, but are not limited to, allergic reactions to contrast agents and impaired renal function.
- Subject with severe comorbidities that could interfere with the study outcomes or pose a risk during surgery and rehabilitation.
- Any other condition precluding implantation of FlexiOss®.
Key Trial Info
Start Date :
May 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07209033
Start Date
May 29 2025
End Date
March 1 2028
Last Update
October 6 2025
Active Locations (1)
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1
Klinika Chirurgii Urazowej Narządu Ruchu i Ortopedii CMKP Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy Centrum Medycznego Kształcenia Podyplomowego
Otwock, Poland, 05-400