Bone Defect
Conditions
Keywords
Bone Defect, Bone Trauma, Bone Injury, Biocomposite, Bone Regeneration
Brief summary
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.
Interventions
DEVICEFlexiOss®
Bone reconstruction with FlexiOss® biocomposite.
PROCEDUREAllogenic human bone grafting
Implantation of allogenic human bone graft.
Sponsors
Medical Inventi S.A.
KCRI
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The trial is double-blinded, keeping sponsor, all patients and the assessors blinded to the treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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®.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy endpoint | At 24-month follow-up | 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) | Up to 24 months | 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 | At 2-week, 6-week, 3-month, 6-month, 12-month & 24-month follow-up | 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. | Up to 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lack of reinterventions in the treated area within 24 months. | Up to 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. | 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. | 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). | After 12 and 24 months | — |
| Assessment of changes in levels of calcium in blood after biocomposite implantation during follow-up at screening, 6 weeks, 6, 12, 24 months. | At screening, 6 weeks, 6, 12, 24 months | The unit of measure will be reported in mg/dL. |
| Assessment of changes in levels of phosphates in blood after biocomposite implantation during follow-up at screening, 6 weeks, 6, 12, 24 months. | At screening, 6 weeks, 6, 12, 24 months | The unit of measure will be reported in IU/L. |
| Proper bone union observed in imaging examination (X-ray) after 6 and 12 months. | After 6 and 12 months | — |
| Assessment of PROM - LEFS obtained individual results at discharge; 2 and 6 weeks; 3, 6, 12 and 24 months. | At baseline; 2 and 6 weeks; 3, 6, 12 and 24 months | The specific PROM assessed here is the Lower Extremity Functional Scale (LEFS). The score ranges from 0 to 80, where a higher score indicates better functional ability. The baseline assessment for this measure is performed at the time of discharge from the hospital. |
| Assessment of PROM - SF-36 obtained individual results at discharge; 2 and 6 weeks; 3, 6, 12 and 24 months. | At baseline; 2 and 6 weeks; 3, 6, 12 and 24 months | The specific PROM assessed here is the SF-36 Health Survey. The scores for each domain are transformed to a scale from 0 to 100, where a higher score indicates a better health outcome. The baseline assessment for this measure is performed at the time of discharge from the hospital. |
Countries
Poland
Contacts
CONTACTAnna Kasprzak-Czelej, PhD
CONTACTBiuro Medical Inventi
PRINCIPAL_INVESTIGATORRafał Kamiński, Professor
Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy CMKP
PRINCIPAL_INVESTIGATORAmadeusz Skiba, PhD
5 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ
Outcome results
None listed