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Tests treatment safety and results for Bone Defect
Official title FlexiOss® - Efficacy, Safety and Long-term (Radiological and Clinical) Outcomes During Comprehensive Care Continuum of Implanted Biocomposite for Bone Regeneration.
ClinicalTrials.gov ID: NCT07209033
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age between 18 and 75 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).
You likely can't join if
- 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...
- Subject with known allergies or hypersensitivity to any components of the FlexiOss® biocomposite material
See the full eligibility criteria
- Age between 18 and 75 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 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®.
The study team makes the final eligibility decision.
Where it's taking place
- Krakow, Poland
- Otwock, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Krakow, Poland; Otwock, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.