Bone DefectsNeocement01NCT06973226
Evaluation of the Safety and Performance of the Neocement®
An observational study of Bone Defects and Orthopaedic Surgery (30 Minutes or Longer), run by Bioceramed at 1 site in Portugal.
Trial summary
This study aims to collect real-world clinical data to gather information on the performance and safety of the Neocement® when used according to its intended purpose and current clinical applications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Defects, Orthopaedic Surgery (30 Minutes or Longer)
- How many people
- 80 participants
- Where
- 1 sitePortugal
- Study dates
- 5 Sep 2025to Jun 2027
- Phase
- Observational
- 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
Study population: The clinical study population consists of adult patients (aged > 18 years old) undergoing orthopaedic surgery to treat bone defects. It is expected that clinical data will be collected from 80 patients implanted with the Neocement® product.
Who may be able to join
- Adult males or females (age > 18 years old);
- Patients with bone defect treatment who meet predefined criteria in Instructions For Use (IFU) of Neocement®;
- Patients who are able to sign an informed consent form (for data collection)
- Patients with bone defects, which may be surgically created or result from traumatic injury to the bone;
- Patients with bone skeletal defects that are not intrinsic to the stability of the bone structure or with a site that can be stabilized;
Who cannot join
- Patients who are unable to understand consent and the objectives of the study;
- Signs of local or systemic acute/ active or chronic infections;
- Metabolic affections;
- Severe degenerative diseases, conditions in which general bone grafting is not advisable;
- Implementation sites that allow product migration;
- Conditions which require structural support in the skeletal system;
Show all 9Show fewer
- Conditions where the implantation site is unstable and not rigidly fixated;
- Sensibility to the implantable materials;
- Known hypersensitivity to the implant material.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Unidade Local de Saúde Esposende/Barcelos
Barcelos
Bruno Pereira, Principal Investigator, (+351) 253 809 200 ext. +351, secadm@hbarcelos.min-saude.pt
About this study
Official title: Evaluation of the Safety and Performance of the Neocement®: A Prospective Observational Study in Orthopaedic Area
This study aims to collect real-world clinical data to gather information on the performance and safety of the Neocement® when used according to its intended purpose and current clinical applications. The results of the clinical study will serve as clinical evidence for the device's clinical evaluation, targeting submission to the new Medical Device Regulation (EU) 2017/745.
Read the detailed description
Neocement® is an innovative calcium phosphate cement, blending the osteointegration and osteoconduction properties of calcium phosphates with the biological benefits of chitosan. This is a synthetic bone substitute primarily composed of calcium phosphates, specifically tetracalcium phosphate and beta-tricalcium phosphate.
Neocement® is intended for use in operating rooms by orthopaedic surgeons experienced in bone grafting techniques. It is suitable for long-term implantation, placed in contact with bone and surrounding tissues using surgical invasive methods. The device is specifically intended for adults (aged > 18 years old) and can be used in multiple units depending on the lesion.
Neocement® is classified as a Class III medical device. Neocement® adheres to stringent regulatory standards for safety and effectiveness in bone regeneration applications. Neocement® is expected to be partially or totally resorbed, from the clinical available data, the expected effect can be predicted to occur after 6 months.
This study based on observations of clinical practice aims to collect clinical data to keep up to date the information on the performance and safety of the medical device when used in accordance with its intended use and current clinical applications. The results of the clinical study shall be used as clinical evidence for clinical evaluation of the device aiming submission to the new Medical Device Regulation (EU) 2017/745.
The post-market study is meant to identify and analyse emerging risks, ensure the continued acceptability of the benefit/risk ratio and also identify possible systematic misuse or unauthorized use of the medical device. This protocol does not include any planned new uses, new populations, new materials or design changes.
The results from the prospective observational post-market study will provide an evidence base for assessing the device's performance and safety after its market launch. Detecting real discrepancies in clinical performance between of the medical device early on can offer valuable opportunities to improve device design. This complements the data collected during the pre-market phases, thus improving patient selection. Active surveillance of the safety of medical devices, achieved through the continuous monitoring of vast sources of clinical data, is a priority in the field of medical devices, a requirement of MDR regulation No. 2017/745. This approach is crucial to achieving the objectives set, guaranteeing the safety and performance of the devices in circulation.
This observational post-market study will collect data relating to standard practice procedures, therefore there are no additional risks or direct benefits associated with participating in this registry for the patient.
Patients will be followed as per local standard medical practices of the centre for 1 year. Clinical data will be collected at 4 points in time: Visit 1 (6 weeks ± 2 weeks - enrolment), Visit 2 (3 months ±3 weeks), Visit 3 (6 months ±3 weeks) and if necessary, a Visit 4 (12 months ±30 days).
- Keywords
- Neocement®, prospective observational clinical study, medical device, performance and safety, bone defects, real-world clinical data, post-market, calcium phosphates, synthetic bone substitute
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Endpoint
Bone consolidation on the surgery site (discrete variable: Yes or No), assessed by X-ray or CT scan.
Measured: 6 weeks; 3 months; 6 months and 12 months (if necessary)
Safety Endpoint
The assessment of Adverse Events and Device deficiencies at least possibly related to Neocement® during the follow-up period of patients.
Measured: 6 weeks; 3 months; 6 months and 12 months (if necessary)
Secondary outcomes (2)
Quality of life measured through the Short Form Health Survey (SF-36) Questionnaire
Quality of life will be assessed during the patients' follow-up period. Patients will complete the SF-36 questionnaire to assess quality of life and to measure the Health Status during recovery. The SF-36 (Short Form Health Survey) is a questionnaire widely used to assess health-related quality of life. Composed of 36 questions, it covers eight main dimensions: physical functioning, limitations due to physical aspects, pain, general health status, vitality, social functioning, limitations due to emotional aspects and mental health. The score in each dimension allows a comprehensive analysis of the patient's perception of their physical and mental well-being, making it a valuable tool both in clinical research and in medical practice for monitoring the health of individuals and populations.
Measured: 6 weeks after surgery; 6 months
Surgeon's Satisfaction survey on the medical device and Technical Success;
To evaluate the Technical Success rate, defined as the successful delivery of the bone substitute into the target defect without any malfunction of the delivery device or the bone substitute itself, and to collect usability feedback on the device during the surgical procedure through a Satisfaction survey. Information on the surgeon's satisfaction with the device under study should be collected post-operatively through a general questionnaire.
Measured: 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start5 Sep 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DefectsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioceramed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Local Health Unit Barcelos/Esposende, Public Health Unit
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973226
- Sponsor's protocol ID
- Neocement01
- Acronym
- Neocement01
- Status last verified
- Feb 2026
- First submitted
- 7 May 2025
- Last updated
- 18 Jun 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 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Performance of the Neocement®: A Prospective Observational Study in Orthopaedic Area
- ClinicalTrials.gov ID
- NCT06973226
- Acronym / sponsor ID
- Neocement01 / Neocement01
- Keywords
- Neocement®, prospective observational clinical study, medical device, performance and safety, bone defects, real-world clinical data, post-market, calcium phosphates
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- BioceramedIndustry (pharma, biotech, devices)
- Collaborators
- Local Health Unit Barcelos/Esposende, Public Health Unit
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 May 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.
This study aims to collect real-world clinical data to gather information on the performance and safety of the Neocement® when used according to its intended purpose and current clinical applications. The results of the clinical study will serve as clinical evidence for the device's clinical evaluation, targeting submission to the new Medical Device Regulation (EU) 2017/745.
Detailed description
Neocement® is an innovative calcium phosphate cement, blending the osteointegration and osteoconduction properties of calcium phosphates with the biological benefits of chitosan. This is a synthetic bone substitute primarily composed of calcium phosphates, specifically tetracalcium phosphate and beta-tricalcium phosphate.
Neocement® is intended for use in operating rooms by orthopaedic surgeons experienced in bone grafting techniques. It is suitable for long-term implantation, placed in contact with bone and surrounding tissues using surgical invasive methods. The device is specifically intended for adults (aged > 18 years old) and can be used in multiple units depending on the lesion.
Neocement® is classified as a Class III medical device. Neocement® adheres to stringent regulatory standards for safety and effectiveness in bone regeneration applications. Neocement® is expected to be partially or totally resorbed, from the clinical available data, the expected effect can be predicted to occur after 6 months.
This study based on observations of clinical practice aims to collect clinical data to keep up to date the information on the performance and safety of the medical device when used in accordance with its intended use and current clinical applications. The results of the clinical study shall be used as clinical evidence for clinical evaluation of the device aiming submission to the new Medical Device Regulation (EU) 2017/745.
The post-market study is meant to identify and analyse emerging risks, ensure the continued acceptability of the benefit/risk ratio and also identify possible systematic misuse or unauthorized use of the medical device. This protocol does not include any planned new uses, new populations, new materials or design changes.
The results from the prospective observational post-market study will provide an evidence base for assessing the device's performance and safety after its market launch. Detecting real discrepancies in clinical performance between of the medical device early on can offer valuable opportunities to improve device design. This complements the data collected during the pre-market phases, thus improving patient selection. Active surveillance of the safety of medical devices, achieved through the continuous monitoring of vast sources of clinical data, is a priority in the field of medical devices, a requirement of MDR regulation No. 2017/745. This approach is crucial to achieving the objectives set, guaranteeing the safety and performance of the devices in circulation.
This observational post-market study will collect data relating to standard practice procedures, therefore there are no additional risks or direct benefits associated with participating in this registry for the patient.
Patients will be followed as per local standard medical practices of the centre for 1 year. Clinical data will be collected at 4 points in time: Visit 1 (6 weeks ± 2 weeks - enrolment), Visit 2 (3 months ±3 weeks), Visit 3 (6 months ±3 weeks) and if necessary, a Visit 4 (12 months ±30 days).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The clinical study population consists of adult patients (aged > 18 years old) undergoing orthopaedic surgery to treat bone defects. It is expected that clinical data will be collected from 80 patients implanted with the Neocement® product.
Key inclusion criteria (5 listed)
- Adult males or females (age > 18 years old);
- Patients with bone defect treatment who meet predefined criteria in Instructions For Use (IFU) of Neocement®;
- Patients who are able to sign an informed consent form (for data collection)
- Patients with bone defects, which may be surgically created or result from traumatic injury to the bone;
- Patients with bone skeletal defects that are not intrinsic to the stability of the bone structure or with a site that can be stabilized;
Key exclusion criteria (9 listed)
- Patients who are unable to understand consent and the objectives of the study;
- Signs of local or systemic acute/ active or chronic infections;
- Metabolic affections;
- Severe degenerative diseases, conditions in which general bone grafting is not advisable;
- Implementation sites that allow product migration;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Performance Endpoint
Time frame: 6 weeks; 3 months; 6 months and 12 months (if necessary)
Bone consolidation on the surgery site (discrete variable: Yes or No), assessed by X-ray or CT scan.
Safety Endpoint
Time frame: 6 weeks; 3 months; 6 months and 12 months (if necessary)
The assessment of Adverse Events and Device deficiencies at least possibly related to Neocement® during the follow-up period of patients.
2 secondary outcomes
Quality of life measured through the Short Form Health Survey (SF-36) Questionnaire
Time frame: 6 weeks after surgery; 6 months
Surgeon's Satisfaction survey on the medical device and Technical Success;
Time frame: 6 weeks after 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 18 Jun 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Defects and Orthopaedic Surgery (30 Minutes or Longer), run by Bioceramed at 1 site 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 9 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 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Alexandre Barros ((+351) 253 573 460 ext. +351, clinicalstudies@bioceramed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Endpoint (time frame: 6 weeks; 3 months; 6 months and 12 months (if necessary)). 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 18 Jun 2026.