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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Bone reconstruction with FlexiOss® biocomposite.
Implantation of allogenic human bone graft.
Klinika Chirurgii Urazowej i Ortopedii 5 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
Krakow, Poland
RECRUITINGKlinika Chirurgii Urazowej Narządu Ruchu i Ortopedii CMKP Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy Centrum Medycznego Kształcenia Podyplomowego
Otwock, Poland
RECRUITINGEfficacy 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 24 months
Lack of reinterventions in the treated area within 24 months.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: At screening, 6 weeks, 6, 12, 24 months
Proper bone union observed in imaging examination (X-ray) after 6 and 12 months.
Time frame: 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.
Time frame: 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.
Time frame: At baseline; 2 and 6 weeks; 3, 6, 12 and 24 months
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