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.
Age between 18 and 75 years.
Subject signed informed consent form and is willing to participate in the follow-up visits.
Long bones of the lower extremity (including articular tibia plateau acute fracture).
Bones of the foot (including articular calcaneus acute fracture).
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.
Parallel
FlexiOss®
DeviceBone reconstruction with FlexiOss® biocomposite.
Allogenic human bone grafting
Procedure/SurgeryImplantation of allogenic human bone graft.
Efficacy endpoint
Presence of bone union with maintained anatomic alignment and stable fixation, including support of the joint surface with a material capable of bone remodelling, as assessed by X-ray or CT at 24 months.
Number and Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)
To measure the number and frequency of adverse event(s) (AEs) including serious adverse event(s) (SAEs) throughout the 24 months study duration.
Improvement of load-bearing capacity with simultaneously reduction of lower extremity dysfunction in the period before and after rehabilitation based on a PROMs (LEFS scale) over 24 months
To assess the improvement of load-bearing capacity and reduction of lower extremity dysfunction in the period before and after rehabilitation. The assessment is based on a Patient-Reported Outcome Measure (PROM), specifically the Lower Extremity Functional Scale (LEFS). The LEFS score ranges from 0 to 80, where a higher score indicates a better functional outcome.
Non-deterioration in Quality of Life (QoL) after completing rehabilitation based on SF-36 questionnaire score.
To assess the non-deterioration in Quality of Life (QoL) using the MOS 36-item Short-Form Health Survey (SF-36). The scores for each domain of the SF-36 are transformed to a scale from 0 to 100, where a higher score indicates a better health outcome.
Lack of reinterventions in the treated area within 24 months.
Full load on the treated limb during physical examination (lower limb bones) at 2 and 6 weeks; 3, 6, 12 and 24 months.
The ability to bear full load on the treated limb is assessed by an experienced orthopedist during scheduled study follow-up visits. The assessment is based on a physical examination where the physician's documented clinical judgment is determined by observing the patient's gait and ability to stand on the treated limb without assistance.
Full mobility of the treated limb during physical examination expressed as active or passive range of motions specific to the studied region at 2 and 6 weeks; 3, 6, 12 and 24 months.
Lack of bone lysis in X-ray after 12 and 24 months (preserving joint surface alignment).
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Medical Inventi S.A.
Lead sponsor
KCRI
Collaborator
