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

NCT07209033 | Recruiting

• 1 other identifier: 24-MED-0003
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Bone Defect

Keywords

Bone Defect; Bone Trauma; Bone Injury; Biocomposite; Bone Regeneration

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (9)

• 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

• 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

Study Arms (2)

Bone reconstruction with FlexiOss® biocomposite

EXPERIMENTAL

Device: FlexiOss®

Control group with allogenic human bone grafting

ACTIVE COMPARATOR

Procedure: Allogenic human bone grafting

Interventions

FlexiOss® DEVICE

Bone reconstruction with FlexiOss® biocomposite.

Bone reconstruction with FlexiOss® biocomposite

Allogenic human bone grafting PROCEDURE

Implantation of allogenic human bone graft.

Control group with allogenic human bone grafting

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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®.

Sponsors & Collaborators

• KCRI: collaborator
• Medical Inventi S.A.: lead

Study Sites (2)

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

Krakow, 30-901, Poland

RECRUITING

Klinika Chirurgii Urazowej Narządu Ruchu i Ortopedii CMKP Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy Centrum Medycznego Kształcenia Podyplomowego

Otwock, 05-400, Poland

RECRUITING

Study Officials

• 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

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The trial is double-blinded, keeping sponsor, all patients and the assessors blinded to the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: October 6, 2025
• Study Start: May 29, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 12, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)