FlexiOss® biocomposite implant for healing acute bone defects

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.

This will see if FlexiOss®, a biocomposite implant, helps adults with recent bone injuries in the lower leg or foot heal better and safely than standard human bone grafts.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Medical Inventi S.A. (Industry-sponsored)
• Locations: 2 sites (Krakow and 1 other locations)
• Trial ID: NCT07209033 on ClinicalTrials.gov

What this trial studies

Adults aged 18–75 with acute primary bone defects in long bones of the lower extremity or bones of the foot who are scheduled for orthopedic surgery will receive either FlexiOss® implant or standard allogenic human bone graft. Clinical and radiological outcomes and safety data will be collected at 2 and 6 weeks and 3, 6, 12 and 24 months after surgery. The study compares bone regeneration, implant performance, and complications across the care continuum. Long-term radiologic assessment and clinical healing measures will be used to judge efficacy and durability.

Who should consider this trial

Good fit: Ideal candidates are adults 18–75 with an acute primary bone defect in a lower extremity long bone or foot bone who are scheduled for surgery and can attend follow-up visits.

Not a fit: People with severe metabolic or degenerative bone disease, pregnancy or breastfeeding, recent substance abuse, unstable psychiatric conditions, or known allergy to FlexiOss® components are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, FlexiOss® could offer an effective alternative to allogenic bone grafts, improving bone healing and long-term repair while possibly reducing complications.

How similar studies have performed: Other biocomposite and synthetic bone graft materials have shown promising but variable results in promoting bone regeneration, while this particular FlexiOss® product appears to be a newer option with limited published long-term data.

Eligibility criteria

Inclusion Criteria:

1. Age between 18 and 75 years.
2. Subject signed informed consent form and is willing to participate in the follow-up visits.
3. Subject with an existing acute primary bone defect in one of the following groups:

   1. Long bones of the lower extremity (including articular tibia plateau acute fracture).
   2. Bones of the foot (including articular calcaneus acute fracture).
4. Subject scheduled for orthopedic procedure with bone substitute material.

Exclusion Criteria:

1. Subject with alcohol dependence syndrome or any history of substance abuse within the past year.
2. Pregnancy or breastfeeding.
3. Subject participates in another clinical trial.
4. Unstable mental condition or psychiatric concomitant disease.
5. Diagnosed severe degenerative, metabolic bone disease or any condition that in opinion of the Investigator could adversely affect bone healing and regeneration.
6. Subject with known allergies or hypersensitivity to any components of the FlexiOss® biocomposite material
7. Subject with active cancer disease and/or during related oncological treatment.
8. 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.
9. Subject with severe comorbidities that could interfere with the study outcomes or pose a risk during surgery and rehabilitation.
10. Any other condition precluding implantation of FlexiOss®.

Where this trial is running

Krakow and 1 other locations

• Klinika Chirurgii Urazowej i Ortopedii 5 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ — Krakow, Poland (Recruiting)
• Klinika Chirurgii Urazowej Narządu Ruchu i Ortopedii CMKP Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy Centrum Medycznego Kształcenia Podyplomowego — Otwock, Poland (Recruiting)

Study contacts

• Principal investigator: Rafał Kamiński, Professor — Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy CMKP
• Study coordinator: Anna Kasprzak-Czelej, PhD

Conditions Bone Defect; Bone Trauma; Bone Injury; Biocomposite; Bone Regeneration