A Prospective, Randomized, Double-blinded, Multi-center, Non-inferiority Study Evaluating 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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
The trial is double-blinded, keeping sponsor, all patients and the assessors blinded to the treatment.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •Long bones of the lower extremity (including articular tibia plateau acute fracture).
- •Bones of the foot (including articular calcaneus acute fracture).
- •Subject scheduled for orthopedic procedure with bone substitute material.
Exclusion Criteria
- •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.
- •Diagnosed severe degenerative, metabolic bone disease or any condition that in opinion of the Investigator could adversely affect bone healing and regeneration.
- •Subject with known allergies or hypersensitivity to any components of the FlexiOss® biocomposite material
- •Subject with active cancer disease and/or during related oncological treatment.
- •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.
- •Subject with severe comorbidities that could interfere with the study outcomes or pose a risk during surgery and rehabilitation.
- •Any other condition precluding implantation of FlexiOss®.
Arms & Interventions
Bone reconstruction with FlexiOss® biocomposite
Intervention: FlexiOss® (Device)
Control group with allogenic human bone grafting
Intervention: Allogenic human bone grafting (Procedure)
Outcomes
Primary Outcomes
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
Time Frame: 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.
Efficacy endpoint
Time Frame: 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)
Time Frame: 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.
Non-deterioration in Quality of Life (QoL) after completing rehabilitation based on SF-36 questionnaire score.
Time Frame: 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 Outcomes
- Lack of reinterventions in the treated area within 24 months.(Up to 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)
- 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)
- 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 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)
- 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)
- 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)