Bone FracturesNCT06736457
Study on Safety and Performance of AdvanCore Bone Void Filler
A study testing AdvanCore bone grafting in people with Bone Fractures and Bone Defects, run by Artur Salgado SA at 4 sites in Portugal.
Trial summary
The objective of this study is to evaluate the safety and performance of AdvanCore implantable bone graft through a 12-month follow-up period in a prospective, parallel-group design, non-controlled, open label, multi-center and real-world setting study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Fractures, Bone Defects, Bone Loss
- What is being tested?
- AdvanCore bone grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 4 sitesPortugal
- Study dates
- 29 May 2025to Oct 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects ≥ 18 years old, male or female.
- Subjects who are eligible for a bone grafting/bone void filler procedure.
- Subjects with bone lesions beyond the limits of the bone's self-healing ability.
- Subjects, and/or an authorized representative, who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center.
- Subjects with only one fracture susceptible to treatment with an AdvanCore implant.
Who cannot join
- Subjects with any AdvanCore contraindication for implantation or use.
- Subjects with hypersensitivity to any of the AdvanCore components.
- Subjects with infections or soft/granulation tissue in the area to place bone graft.
- Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study.
- Women who are breastfeeding or of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion).
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal4 sites, 4 recruiting
- Recruiting
Unidade Local de Saúde do Alto Ave
Guimarães, Braga District, 4835-044
Ana Sofia F Costa, +351253540330, sofiafreitascosta@hospitaldeguimaraes.min-saude.pt
Carlos A Vilela Gomes, Orthopaedic surgeon
- Recruiting
Unidade Local de Saúde de Trás-os-Montes e Alto Douro
Lordelo, Vila Real District, 5000-508
Catarina S dos Santos, +351259300500, cslsantos@chtmad.min-saude.pt
Carlos E Pintado, Orthopeadic Surgeon
- Not yet recruiting
Unidade Local de Saúde de São João
Porto, Porto District, 4200-319
Teresa Burnay, +351225512100, ca@chsj.min-saude.pt
Teresa Burnay, Maxillofacial surgeon
- Not yet recruiting
Unidade Local de Saúde do Médio Tejo
Tomar, Santarém District, 2304-909
Ana Rita B Reis, +351249320100, rita.reis@ulsmt.min-saude.pt
Amílcar J Valverde, Orthopaedic surgeon
About this study
The objective of this study is to evaluate the safety and performance of AdvanCore implantable bone graft through a 12-month follow-up period in a prospective, parallel-group design, non-controlled, open label, multi-center and real-world setting study. This study is intended to satisfy post-market clinical follow-up requirements of CE Mark in Europe.
Read the detailed description
AdvanCore is a porous beta-tricalcium phosphate CE-marked medical device. It is intended to be used to aid in the bone regeneration process in situations where bone is damaged beyond the limits of its self-healing ability. The target population is constituted by adult subjects in need of bone grafting of mechanically unaffected, pathologic, or traumatic bone defects caused by surgery or trauma.
AdvanCore is produced in the shape of blocks, wedges, or granules in different sizes and is surgically placed into spaces between or around broken bone (fractures) or in holes (defects). The site to be augmented must be free from infection and free from soft or granulation tissue. AdvanCore must contact cancelous bone and may be pressed into the defect area by hand or shaped more accurately to fit the area. It can be used as is, impregnated with subjects' blood/ bone marrow and/ or mixed with medicinal substances under the responsibility of the qualified professionals.
AdvanCore acts as a temporary scaffold and is not intended to provide mechanical support during the healing process. Additional therapy for load-bearing (such as osteosynthesis) is indicated if the bone does not comply with the required biomechanical function.
The study on safety and performance of AdvanCore bone void filler will be conducted in European sites and include up to 190 subjects requiring bone implant surgery, which will be divided in 3 different groups:
- Group 1- This group is formed by those subjects with long-bone injuries. The treatment of this type of lesion may be performed using blocks, wedges, or granules.
- Group 2- Subjects included in this group suffer from spine injuries, which can be treated using granules.
- Group 3- Those subjects with maxillofacial injuries are included in this group. In this case, granules are used to treat the lesion.
The primary safety endpoint of this study is defined as freedom of bone reintervention due to AdvanCore usage at 6 months, analyzing the occurrence of Adverse Events or Serious Adverse Events [(S)AEs] related to the device usage and/ or AdvanCore procedure that may lead to subjects' reoperation.
The primary performance endpoint will analyze the AdvanCore osteointegration after 6 months of surgery, studying the percentage of subjects with successful osteointegration at the defined time point. AdvanCore will be considered successfully osteointegrated when no presence of fibrotic tissue surrounding the implant is detected.
Secondary endpoints planned for this clinical investigation are listed below:
- Evaluation of (S)AEs related to the procedure;
- Evaluation of (S)AEs related to the device;
- Freedom of reintervention due to AdvanCore usage;
- AdvanCore osteointegration;
- AdvanCore resorption rate, assessed as the percentage of subjects with successful bone graft resorption.
The clinical investigation has been designed to involve as little pain, discomfort, fear, and any other foreseeable risk as possible for subjects.
- Conditions
- Bone Fractures, Bone Defects, Bone Loss, Bone Graft
- Being tested
- AdvanCore bone grafting
- Keywords
- Bone graft, Bone substitute, Bone regeneration, AdvanCore, Beta-Tricalcium Phosphate, Synthetic bone graft
- Medical subject headings
- Fractures, Bone, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdvanCore bone graftingProcedure or surgery
AdvanCore medical device is implanted making sure that is in direct contact with all surfaces of the defect area.
| Study group | Role | What they receive |
|---|---|---|
| Long-bone injuries | Experimental | Group formed by subjects with long-bone injuries treated using AdvanCore blocks, wedges, or granules. Receives: Procedure: AdvanCore bone grafting |
| Spine injuries | Experimental | Group formed by subjects with spine injuries treated using AdvanCore granules. Receives: Procedure: AdvanCore bone grafting |
| Maxillofacial injuries | Experimental | Group formed by subjects with maxillofacial injuries treated using AdvanCore granules. Receives: Procedure: AdvanCore bone grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom of bone reintervention (safety)
The primary safety endpoint is defined as freedom of bone reintervention due to AdvanCore usage at 6 months, analyzing the occurrence of (S)AEs related to the device usage and/ or AdvanCore procedure that may lead to subjects' reoperation.
Measured: 6 months post-surgery
Successful osteointegration (performance)
The primary performance endpoint will analyze the AdvanCore integration at 6 months of surgery. This process is defined as osteointegration, which refers to the direct structural and functional connection of the living bone with the surface of the implant. The implant osteointegration will be assessed by imaging techniques selected according to the current clinical practices of each site. In this regard, the primary performance endpoint will be analyzed by considering the percentage of subjects with successful osteointegration at the defined timeline. AdvanCore will be considered successfully osteointegrated when the presence of fibrotic tissue surrounding the implant is not detected.
Measured: 6 months post-surgery
Secondary outcomes (14)
Evaluation of Adverse Events or Serious Adverse Events [(S)AEs] related to the procedure (safety)
Record of Adverse Events or Serious Adverse Events [(S)AEs] related to the procedure during a 12-month follow-up period. In all cases, the analysis population will be the Per-Protocol population, and results will be presented as the incidence (in percentage) of (S)AEs, with a 95% confidence.
Measured: 30-days post-surgery
Evaluation of (S)AEs related to the procedure (safety)
Record of (S)AEs related to the procedure during a 12-month follow-up period. In all cases, the analysis population will be the Per-Protocol population, and results will be presented as the incidence (in percentage) of (S)AEs, with a 95% confidence.
Measured: 3 months post-surgery
Evaluation of (S)AEs related to the procedure (safety)
Record of (S)AEs related to the procedure during a 12-month follow-up period. In all cases, the analysis population will be the Per-Protocol population, and results will be presented as the incidence (in percentage) of (S)AEs, with a 95% confidence.
Measured: 6 months post-surgery
Evaluation of (S)AEs related to the procedure (safety)
Record of (S)AEs related to the procedure during a 12-month follow-up period. In all cases, the analysis population will be the Per-Protocol population, and results will be presented as the incidence (in percentage) of (S)AEs, with a 95% confidence.
Measured: 12 months post-surgery
Evaluation of (S)AEs related to the device (safety)
Record of (S)AEs related to the device during a 12-month follow-up period. In all cases, the analysis population will be the Per-Protocol population, and results will be presented as the incidence (in percentage) of (S)AEs, with a 95% confidence.
Measured: 30 days post-surgery
Evaluation of (S)AEs related to the device (safety)
Record of (S)AEs related to the device during a 12-month follow-up period. In all cases, the analysis population will be the Per-Protocol population, and results will be presented as the incidence (in percentage) of (S)AEs, with a 95% confidence.
Measured: 3 months post-surgery
Evaluation of (S)AEs related to the device (safety)
Record of (S)AEs related to the device during a 12-month follow-up period. In all cases, the analysis population will be the Per-Protocol population, and results will be presented as the incidence (in percentage) of (S)AEs, with a 95% confidence.
Measured: 6 months post-surgery
Evaluation of (S)AEs related to the device (safety)
Record of (S)AEs related to the device during a 12-month follow-up period. In all cases, the analysis population will be the Per-Protocol population, and results will be presented as the incidence (in percentage) of (S)AEs, with a 95% confidence.
Measured: 12 months post-surgery
Freedom of reintervention (safety)
Freedom of reintervention due to AdvanCore usage, analyzing the occurrence of (S)AEs related to the device usage and/ or AdvanCore procedure that may lead to subjects' reoperation.
Measured: 12 months post-surgery
Successful osteointegration (performance)
The implant osteointegration will be assessed by imaging techniques selected according to the current clinical practices of each site. This analysis will determine the percentage of number of subjects with successful implant osteointegration. AdvanCore will be considered successfully osteointegrated when the presence of fibrotic tissue surrounding the implant is not detected.
Measured: 30 days post-surgery
Successful osteointegration (performance)
The implant osteointegration will be assessed by imaging techniques selected according to the current clinical practices of each site. This analysis will determine the percentage of number of subjects with successful implant osteointegration. AdvanCore will be considered successfully osteointegrated when the presence of fibrotic tissue surrounding the implant is not detected.
Measured: 3 months post-surgery
Successful osteointegration (performance)
The implant osteointegration will be assessed by imaging techniques selected according to the current clinical practices of each site. This analysis will determine the percentage of number of subjects with successful implant osteointegration. AdvanCore will be considered successfully osteointegrated when the presence of fibrotic tissue surrounding the implant is not detected.
Measured: 12 months post-surgery
Successful resorption (performance)
Resorption is the breakdown and assimilation of the implant in the cycle of bone growth. The implant resorption will be assessed by imaging techniques selected according to the current clinical practices of each site. This analysis will determine the percentage of number of subjects with successful implant resorption. The successful resorption rate will be reached if at least 25% of the AdvanCore graft cannot be detected at 6 months.
Measured: 6 months post-surgery
Successful resorption (performance)
Resorption is the breakdown and assimilation of the implant in the cycle of bone growth. The implant resorption will be assessed by imaging techniques selected according to the current clinical practices of each site. This analysis will determine the percentage of number of subjects with successful implant resorption. The successful resorption rate will be reached if at least 50% of the AdvanCore graft cannot be detected at 12 months.
Measured: 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start29 May 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone FracturesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Artur Salgado SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736457
- Sponsor's protocol ID
- ADV-01
- Status last verified
- May 2025
- First submitted
- 11 Dec 2024
- Last updated
- 31 May 2025
- 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 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Safety and Performance of AdvanCore Bone Void Filler
- ClinicalTrials.gov ID
- NCT06736457
- Acronym / sponsor ID
- ADV-01
- Conditions
- Bone Fractures, Bone Defects, Bone Loss, Bone Graft
- Keywords
- Bone graft, Bone substitute, Bone regeneration, AdvanCore, Beta-Tricalcium Phosphate, Synthetic bone graft
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Artur Salgado SAIndustry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Study start
- 29 May 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 16 Dec 2024 (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 objective of this study is to evaluate the safety and performance of AdvanCore implantable bone graft through a 12-month follow-up period in a prospective, parallel-group design, non-controlled, open label, multi-center and real-world setting study. This study is intended to satisfy post-market clinical follow-up requirements of CE Mark in Europe.
Detailed description
AdvanCore is a porous beta-tricalcium phosphate CE-marked medical device. It is intended to be used to aid in the bone regeneration process in situations where bone is damaged beyond the limits of its self-healing ability. The target population is constituted by adult subjects in need of bone grafting of mechanically unaffected, pathologic, or traumatic bone defects caused by surgery or trauma.
AdvanCore is produced in the shape of blocks, wedges, or granules in different sizes and is surgically placed into spaces between or around broken bone (fractures) or in holes (defects). The site to be augmented must be free from infection and free from soft or granulation tissue. AdvanCore must contact cancelous bone and may be pressed into the defect area by hand or shaped more accurately to fit the area. It can be used as is, impregnated with subjects' blood/ bone marrow and/ or mixed with medicinal substances under the responsibility of the qualified professionals.
AdvanCore acts as a temporary scaffold and is not intended to provide mechanical support during the healing process. Additional therapy for load-bearing (such as osteosynthesis) is indicated if the bone does not comply with the required biomechanical function.
The study on safety and performance of AdvanCore bone void filler will be conducted in European sites and include up to 190 subjects requiring bone implant surgery, which will be divided in 3 different groups:
- Group 1- This group is formed by those subjects with long-bone injuries. The treatment of this type of lesion may be performed using blocks, wedges, or granules.
- Group 2- Subjects included in this group suffer from spine injuries, which can be treated using granules.
- Group 3- Those subjects with maxillofacial injuries are included in this group. In this case, granules are used to treat the lesion.
The primary safety endpoint of this study is defined as freedom of bone reintervention due to AdvanCore usage at 6 months, analyzing the occurrence of Adverse Events or Serious Adverse Events [(S)AEs] related to the device usage and/ or AdvanCore procedure that may lead to subjects' reoperation.
The primary performance endpoint will analyze the AdvanCore osteointegration after 6 months of surgery, studying the percentage of subjects with successful osteointegration at the defined time point. AdvanCore will be considered successfully osteointegrated when no presence of fibrotic tissue surrounding the implant is detected.
Secondary endpoints planned for this clinical investigation are listed below:
- Evaluation of (S)AEs related to the procedure;
- Evaluation of (S)AEs related to the device;
- Freedom of reintervention due to AdvanCore usage;
- AdvanCore osteointegration;
- AdvanCore resorption rate, assessed as the percentage of subjects with successful bone graft resorption.
The clinical investigation has been designed to involve as little pain, discomfort, fear, and any other foreseeable risk as possible for subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Long-bone injuries | Experimental | Procedure: AdvanCore bone graftingGroup formed by subjects with long-bone injuries treated using AdvanCore blocks, wedges, or granules. |
| Spine injuries | Experimental | Procedure: AdvanCore bone graftingGroup formed by subjects with spine injuries treated using AdvanCore granules. |
| Maxillofacial injuries | Experimental | Procedure: AdvanCore bone graftingGroup formed by subjects with maxillofacial injuries treated using AdvanCore granules. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult subjects ≥ 18 years old, male or female.
- Subjects who are eligible for a bone grafting/bone void filler procedure.
- Subjects with bone lesions beyond the limits of the bone's self-healing ability.
- Subjects, and/or an authorized representative, who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center.
- Subjects with only one fracture susceptible to treatment with an AdvanCore implant.
Key exclusion criteria (5 listed)
- Subjects with any AdvanCore contraindication for implantation or use.
- Subjects with hypersensitivity to any of the AdvanCore components.
- Subjects with infections or soft/granulation tissue in the area to place bone graft.
- Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study.
- Women who are breastfeeding or of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion).
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 |
|---|---|---|
| AdvanCore bone graftingAdvanCore medical device is implanted making sure that is in direct contact with all surfaces of the defect area. | Procedure or surgery | Long-bone injuries, Maxillofacial injuries, Spine injuries |
Primary outcome
Freedom of bone reintervention (safety)
Time frame: 6 months post-surgery
The primary safety endpoint is defined as freedom of bone reintervention due to AdvanCore usage at 6 months, analyzing the occurrence of (S)AEs related to the device usage and/ or AdvanCore procedure that may lead to subjects' reoperation.
Successful osteointegration (performance)
Time frame: 6 months post-surgery
The primary performance endpoint will analyze the AdvanCore integration at 6 months of surgery. This process is defined as osteointegration, which refers to the direct structural and functional connection of the living bone with the surface of the implant. The implant osteointegration will be assessed by imaging techniques selected according to the current clinical practices of each site. In this regard, the primary performance endpoint will be analyzed by considering the percentage of subjects with successful osteointegration at the defined timeline. AdvanCore will be considered successfully osteointegrated when the presence of fibrotic tissue surrounding the implant is not detected.
14 secondary outcomes
Evaluation of Adverse Events or Serious Adverse Events [(S)AEs] related to the procedure (safety)
Time frame: 30-days post-surgery
Evaluation of (S)AEs related to the procedure (safety)
Time frame: 3 months post-surgery
Evaluation of (S)AEs related to the procedure (safety)
Time frame: 6 months post-surgery
Evaluation of (S)AEs related to the procedure (safety)
Time frame: 12 months post-surgery
Evaluation of (S)AEs related to the device (safety)
Time frame: 30 days post-surgery
Evaluation of (S)AEs related to the device (safety)
Time frame: 3 months post-surgery
Evaluation of (S)AEs related to the device (safety)
Time frame: 6 months post-surgery
Evaluation of (S)AEs related to the device (safety)
Time frame: 12 months post-surgery
Freedom of reintervention (safety)
Time frame: 12 months post-surgery
Successful osteointegration (performance)
Time frame: 30 days post-surgery
Successful osteointegration (performance)
Time frame: 3 months post-surgery
Successful osteointegration (performance)
Time frame: 12 months post-surgery
Successful resorption (performance)
Time frame: 6 months post-surgery
Successful resorption (performance)
Time frame: 12 months post-surgery
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 31 May 2025.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AdvanCore bone grafting in people with Bone Fractures and Bone Defects, run by Artur Salgado SA at 4 sites in Portugal.
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 5 inclusion and 5 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 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Portugal. 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 Francisca C Costa (+351253794649, f.costa@artursalgado.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom of bone reintervention (safety) (time frame: 6 months post-surgery). The study lists 2 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 31 May 2025.