Actively Recruiting
FlexiOss® - Efficacy, Safety and Long-term (Radiological and Clinical) Outcomes During Comprehensive Care Continuum of Implanted Biocomposite for Bone Regeneration.
Led by Medical Inventi S.A. · Updated on 2026-02-12
80
Participants Needed
2
Research Sites
157 weeks
Total Duration
On this page
Sponsors
M
Medical Inventi S.A.
Lead Sponsor
K
KCRI
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FlexiOss® - Efficacy, Safety and Long-term (Radiological and Clinical) Outcomes During Comprehensive Care Continuum of Implanted Biocomposite for Bone Regeneration.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Signed informed consent and willingness to participate in follow-up visits
- Existing acute primary bone defect in long bones of the lower extremity or bones of the foot
- Scheduled for an orthopedic procedure using bone substitute material
You will not qualify if you...
- Alcohol dependence syndrome or substance abuse within the past year
- Pregnancy or breastfeeding
- Participation in another clinical trial
- Unstable mental condition or psychiatric disease
- Severe degenerative or metabolic bone disease affecting healing
- Allergy or hypersensitivity to FlexiOss4 components
- Active cancer or undergoing cancer treatment
- Contraindications to computed tomography angiography (e.g., allergy to contrast agents, impaired kidney function)
- Severe comorbidities posing risk during surgery or rehabilitation
- Any condition preventing implantation of FlexiOss4
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Klinika Chirurgii Urazowej i Ortopedii 5 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
Krakow, Poland, 30-901
Actively Recruiting
2
Klinika Chirurgii Urazowej Narządu Ruchu i Ortopedii CMKP Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy Centrum Medycznego Kształcenia Podyplomowego
Otwock, Poland, 05-400
Actively Recruiting
Research Team
A
Anna Kasprzak-Czelej, PhD
CONTACT
B
Biuro Medical Inventi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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