Bone DefectFlexiOssOTNCT07209033
FlexiOss® - Efficacy, Safety and Long-term (Radiological and Clinical) Outcomes During Comprehensive Care Continuum of Implanted Biocomposite for Bone Regeneration.
A study testing FlexiOss® and Allogenic human bone grafting in people with Bone Defect, run by Medical Inventi S.A. at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bone Defect
- What is being tested?
- FlexiOss® and Allogenic human bone grafting
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesPoland
- Study dates
- 29 May 2025to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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®.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites, 2 recruiting
- Recruiting
Klinika Chirurgii Urazowej i Ortopedii 5 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
Krakow, 30-901
Amadeusz Skiba, PhD, +48 (12) 630-82-03, ortopedia@5wszk.com.pl
Amadeusz Skiba, PhD
- Recruiting
Klinika Chirurgii Urazowej Narządu Ruchu i Ortopedii CMKP Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy Centrum Medycznego Kształcenia Podyplomowego
Otwock, 05-400
Rafał Kamiński, Professor, +48 (22) 788-56-75, kl.chir.ur@spskgruca.pl
Rafał Kamiński, Professor
About this study
Official 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.
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
- Being tested
- FlexiOss®, Allogenic human bone grafting
- Keywords
- Bone Defect, Bone Trauma, Bone Injury, Biocomposite, Bone Regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlexiOss®Device
Bone reconstruction with FlexiOss® biocomposite.
Allogenic human bone graftingProcedure or surgery
Implantation of allogenic human bone graft.
| Study group | Role | What they receive |
|---|---|---|
| Bone reconstruction with FlexiOss® biocomposite | Experimental | Not described Receives: Device: FlexiOss® |
| Control group with allogenic human bone grafting | Active comparator | Not described Receives: Procedure: Allogenic human bone grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 24 months
Secondary outcomes (9)
Lack of reinterventions in the treated area within 24 months.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: At screening, 6 weeks, 6, 12, 24 months
Proper bone union observed in imaging examination (X-ray) after 6 and 12 months.
Measured: 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.
Measured: 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.
Measured: At baseline; 2 and 6 weeks; 3, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start29 May 2025
- Primary completionMar 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Inventi S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KCRI
- Responsible party
- Sponsor
- Investigators
- Rafał Kamiński, Professor, Principal investigator, Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy CMKPAmadeusz Skiba, PhD, Principal investigator, 5 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209033
- Sponsor's protocol ID
- 24-MED-0003
- Acronym
- FlexiOssOT
- Status last verified
- Sep 2025
- First submitted
- 14 Aug 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07209033
- Acronym / sponsor ID
- FlexiOssOT / 24-MED-0003
- Conditions
- Bone Defect
- Keywords
- Bone Defect, Bone Trauma, Bone Injury, Biocomposite, Bone Regeneration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical Inventi S.A.Industry (pharma, biotech, devices)
- Collaborators
- KCRI
- Study start
- 29 May 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone reconstruction with FlexiOss® biocomposite | Experimental | Device: FlexiOss® |
| Control group with allogenic human bone grafting | Active comparator | Procedure: Allogenic human bone grafting |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlexiOss®Bone reconstruction with FlexiOss® biocomposite. | Device | Bone reconstruction with FlexiOss® biocomposite |
| Allogenic human bone graftingImplantation of allogenic human bone graft. | Procedure or surgery | Control group with allogenic human bone grafting |
Primary 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.
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.
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.
9 secondary outcomes
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.
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.
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.
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.
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.
Time frame: At baseline; 2 and 6 weeks; 3, 6, 12 and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rafał Kamiński, Professor principal investigator
Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy CMKP
Amadeusz Skiba, PhD principal investigator
5 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FlexiOss® and Allogenic human bone grafting in people with Bone Defect, run by Medical Inventi S.A. at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Kasprzak-Czelej, PhD (+48 502 238 822, anna.kasprzak-czelej@medicalinventi.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy endpoint (time frame: At 24-month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.