FlexiOss®

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-29

Study Completion Date

2028-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bone Defect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The trial is double-blinded, keeping sponsor, all patients and the assessors blinded to the treatment.

Study Groups

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Bone reconstruction with FlexiOss® biocomposite

Group Type EXPERIMENTAL

Intervention Type DEVICE

Bone reconstruction with FlexiOss® biocomposite.

Control group with allogenic human bone grafting

Group Type ACTIVE_COMPARATOR

Allogenic human bone grafting

Intervention Type PROCEDURE

Implantation of allogenic human bone graft.

Interventions

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FlexiOss®

Bone reconstruction with FlexiOss® biocomposite.

Intervention Type DEVICE

Allogenic human bone grafting

Implantation of allogenic human bone graft.

Intervention Type PROCEDURE

Eligibility Criteria

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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®.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No