FlexiOss® - Efficacy, Safety and Long-term (Radiological and Clinical) Outcomes During Comprehensive Care Continuum of Implanted Biocomposite for Bone Regeneration. (FlexiOssOT)

Medical Inventi S.A.

Status: Enrolling

Conditions: Bone Defect

Treatments: Procedure: Allogenic human bone grafting; Device: FlexiOss®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07209033

24-MED-0003

Details and patient eligibility

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 18 and 70 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.

5. Subject with bone defects volume that can be completely filled using a maximum of the one largest FlexiOss® fitting.

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®.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Bone reconstruction with FlexiOss® biocomposite

Experimental group

Treatment:

Device: FlexiOss®

Control group with allogenic human bone grafting

Active Comparator group

Treatment:

Procedure: Allogenic human bone grafting