FlexiOss® biocomposite implant for healing acute bone defects

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: anna.kasprzak-czelej@medicalinventi.pl
• Phone: +48 502 238 822

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.