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| Name | Class |
|---|---|
| KCRI | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bone reconstruction with FlexiOss® biocomposite | Experimental |
| |
| Control group with allogenic human bone grafting | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FlexiOss® | Device | Bone reconstruction with FlexiOss® biocomposite. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 24-month follow-up |
| 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. | Up to 24 months |
| 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. | At 2-week, 6-week, 3-month, 6-month, 12-month & 24-month follow-up |
| 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. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion 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:
Subject scheduled for orthopedic procedure with bone substitute material.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Kasprzak-Czelej, PhD | Contact | +48 502 238 822 | anna.kasprzak-czelej@medicalinventi.pl | |
| Biuro Medical Inventi | Contact | (+48) 667 330 883 | biuro@medicalinventi.pl |
| Name | Affiliation | Role |
|---|---|---|
| Rafał Kamiński, Professor | Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy CMKP | Principal Investigator |
| Amadeusz Skiba, PhD | 5 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinika Chirurgii Urazowej i Ortopedii 5 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ | Recruiting | Krakow | 30-901 | Poland |
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The trial is double-blinded, keeping sponsor, all patients and the assessors blinded to the treatment.
| Allogenic human bone grafting | Procedure | Implantation of allogenic human bone graft. |
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| At 2 and 6 weeks; 3, 6, 12 and 24 months |
| 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. | The unit of measure will be reported in mg/dL. | At screening, 6 weeks, 6, 12, 24 months |
| Assessment of changes in levels of phosphates in blood after biocomposite implantation during follow-up at screening, 6 weeks, 6, 12, 24 months. | The unit of measure will be reported in IU/L. | At screening, 6 weeks, 6, 12, 24 months |
| 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. | 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. | At baseline; 2 and 6 weeks; 3, 6, 12 and 24 months |
| Assessment of PROM - SF-36 obtained individual results at discharge; 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. | At baseline; 2 and 6 weeks; 3, 6, 12 and 24 months |
| Klinika Chirurgii Urazowej Narządu Ruchu i Ortopedii CMKP Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy Centrum Medycznego Kształcenia Podyplomowego | Recruiting | Otwock | 05-400 | Poland |
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