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NCT Number: NCT07209033

FlexiOss® - Efficacy, Safety and Long-term (Radiological and Clinical) Outcomes During Comprehensive Care Continuum of Implanted Biocomposite for Bone Regeneration.

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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Key information

Conditions

Bone Defect

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinika Chirurgii Urazowej i Ortopedii 5 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ, Krakow, Poland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®.

Treatment and study plan

FlexiOss®

Device

Bone reconstruction with FlexiOss® biocomposite.

Allogenic human bone grafting

Procedure

Implantation of allogenic human bone graft.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  1. Lack of reinterventions in the treated area within 24 months.

    Time frame: Up to 24 months

  2. Full load on the treated limb during physical examination (lower limb bones) at 2 and 6 weeks; 3, 6, 12 and 24 months.

    Time frame: 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.

  3. 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

  4. Lack of bone lysis in X-ray after 12 and 24 months (preserving joint surface alignment).

    Time frame: After 12 and 24 months

  5. Assessment of changes in levels of calcium in blood after biocomposite implantation during follow-up at screening, 6 weeks, 6, 12, 24 months.

    Time frame: At screening, 6 weeks, 6, 12, 24 months

    The unit of measure will be reported in mg/dL.

  6. Assessment of changes in levels of phosphates in blood after biocomposite implantation during follow-up at screening, 6 weeks, 6, 12, 24 months.

    Time frame: At screening, 6 weeks, 6, 12, 24 months

    The unit of measure will be reported in IU/L.

  7. Proper bone union observed in imaging examination (X-ray) after 6 and 12 months.

    Time frame: After 6 and 12 months

  8. Assessment of PROM - LEFS obtained individual results at discharge; 2 and 6 weeks; 3, 6, 12 and 24 months.

    Time frame: 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.

  9. Assessment of PROM - SF-36 obtained individual results at discharge; 2 and 6 weeks; 3, 6, 12 and 24 months.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Kasprzak-Czelej, PhD

CONTACT

[email protected]

+48 502 238 822

Biuro Medical Inventi

CONTACT

[email protected]

(+48) 667 330 883

Sponsors and collaborators

Lead sponsor

Medical Inventi S.A.

Industry

Collaborators

  • KCRI

Registry information

Official study title

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.

Acronym: FlexiOssOT

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 6, 2025
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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