Bone DeformityNCT05676905
Prospective Multicenter Observational Study on the Use of NEOCEMENT® for the Treatment of Bone Defects
An observational study of Bone Deformity, run by Bioceramed at 1 site in Portugal.
Trial summary
Neocement is a CE marked device, registered in INFARMED (Portuguese National Competent Authority) and Department of Planning and Organisation of the National Health Service - General board of Medical Devices, pharmaceutical services, and safety in healthcare (Italy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Deformity
- What is being tested?
- Neocement
- Type of treatment
- Medical device
- How many people
- 165 participants
- Where
- 1 sitePortugal
- Study dates
- 6 Nov 2024to 6 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Bone graft substitute patients who underwent surgery with Neocement and meet the eligibility criteria.
Who may be able to join
- Patients with bone defect treatment who meet predefined criteria in Instructions For Use (IFU) of Neocement® / Neocement® Inject P.
- Age ≥ 18 years of both genders (male and female)
- Patient signed informed consent form (for data collection)
- Bone defects surgically created or osseous defects created from traumatic injury to the bone
- Bone skeletal defects that are not intrinsic to the stability of bone structure OR site which can be stabilized
Who cannot join
- Acute or chronic infection at the surgical site;
- Metabolic bone diseases;
- Severe degenerative disease conditions in which general bone grafting is not advisable;
- Active malignancy.
- Inability to understand consent and objectives of the study;
- Pregnant women or breastfeeding women;
- Unable to undergo medical monitoring for geographical, social or psychological reasons.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Centro Hospitalar Universitário de Lisboa Central
Lisbon, Lisbon District
About this study
Neocement is a CE marked device, registered in INFARMED (Portuguese National Competent Authority) and Department of Planning and Organisation of the National Health Service - General board of Medical Devices, pharmaceutical services, and safety in healthcare (Italy). This protocol does not include any new intended uses, new populations, new materials or design changes.
Read the detailed description
Neocement developed by Bioceramed is a calcium phosphate cement, composed of a liquid and a solid phase that upon mixing form a mouldable paste which hardens within 4-8 minutes due to an isothermal reaction.
This device is intended to be used in filling bony voids or gaps in the extremities, which have either been surgically created, or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Hence, it is intended to be used by healthcare professionals (surgeons) when bone ingrowth and consolidation are required.
Neocement is contraindicated to use in load bearing applications, and must not be used where the implantation site is unstable and not rigidly fixed. Additionally, it is also not indicated to use in cases where the implantation site presents infection, nor in cases where poor bone healing would be expected, such as metabolic, immunologic or systemic disorders.
Bone grafting technique has been employed for several decades by orthopaedic surgeons to potentiate the process of bone repair across all orthopaedics' subspecialties.
Despite autografts with cancellous bone being considered the "gold standard" for bone regeneration due to their osteogenic elements, there are numerous disadvantages associated to this technique, including extended surgical time, local pain and swelling from donor segments.
The use of synthetic substitutes, like calcium phosphate cements, have significant advantages, including decreased risk of infection from human pathogens, and unlimited availability in various shapes and sizes. Thus, reconstruction and/or filling of bone defects caused by trauma, disease, or tumour resection in long bones using calcium phosphate cements has proven to be an effective and safe alternative to reduce donor-site morbidity associated to autografting, whilst providing support for bone regeneration.
- Conditions
- Bone Deformity
- Being tested
- Neocement
- Keywords
- Bone cement, Observational study, Real-world study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeocementDevice
Also called Neocement Inject P
Bone graft substitutes
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone consolidation (Neer/ RUST classification)
Neer classification is used for trabecular bone:
Healed: Cyst filled by new bone, with or without small radiolucent area(s) < 1 cm in size
Healing with defects: Radiolucent area(s) < 50% of the diameter of bone, with enough cortical thickness to prevent fracture
Persistent cyst: Radiolucent area > 50% of diameter of the bone and with a thin cortical rim. No increase in the size of the cyst.
Recurrent cyst: Cyst reappeared in a previously obliterated area, or a residual radiolucent area has increased in size)
RUST is classified according to the scores:
Score 1: Fracture Line, No Callus
Score 2: Fracture Line, Visible Callus
Score 3: Fracture Line, Bridging Callus
Score 4: No fracture line, remodelled
Measured: 24 months
Secondary outcomes (1)
Functional scores
Functional scores are classified as Hip disability and Osteoarthritis Outcome Score, Knee disability and Osteoarthritis Outcome Score, Foot and Ankle Ability Measure, where 0 points is the worst possible score and 100 points is the best possible score.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start6 Nov 2024
- Primary completion6 Nov 2024
- Study completion6 Nov 2024
Why it stopped: The study was terminated following a change in company management.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DeformityStudies 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
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioceramed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Clinical Research Infrastructure Network, Horizon 2020 - European Commission
- Responsible party
- Sponsor
- Investigators
- Nuno Ribeiro, M. Doctor, Study chair, Hospital Lusíadas Lisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676905
- Sponsor's protocol ID
- TBMED1.1
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2022
- Last updated
- 31 Jan 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 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Observational Study on the Use of NEOCEMENT® for the Treatment of Bone Defects
- ClinicalTrials.gov ID
- NCT05676905
- Acronym / sponsor ID
- TBMED1.1
- Conditions
- Bone Deformity
- Keywords
- Bone cement, Observational study, Real-world study
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated following a change in company management.
- Enrolment
- 165 participants (actual)
- Lead sponsor
- BioceramedIndustry (pharma, biotech, devices)
- Collaborators
- European Clinical Research Infrastructure Network, Horizon 2020 - European Commission
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 6 Nov 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 9 Jan 2023 (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.
Neocement is a CE marked device, registered in INFARMED (Portuguese National Competent Authority) and Department of Planning and Organisation of the National Health Service - General board of Medical Devices, pharmaceutical services, and safety in healthcare (Italy). This protocol does not include any new intended uses, new populations, new materials or design changes.
Detailed description
Neocement developed by Bioceramed is a calcium phosphate cement, composed of a liquid and a solid phase that upon mixing form a mouldable paste which hardens within 4-8 minutes due to an isothermal reaction.
This device is intended to be used in filling bony voids or gaps in the extremities, which have either been surgically created, or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Hence, it is intended to be used by healthcare professionals (surgeons) when bone ingrowth and consolidation are required.
Neocement is contraindicated to use in load bearing applications, and must not be used where the implantation site is unstable and not rigidly fixed. Additionally, it is also not indicated to use in cases where the implantation site presents infection, nor in cases where poor bone healing would be expected, such as metabolic, immunologic or systemic disorders.
Bone grafting technique has been employed for several decades by orthopaedic surgeons to potentiate the process of bone repair across all orthopaedics' subspecialties.
Despite autografts with cancellous bone being considered the "gold standard" for bone regeneration due to their osteogenic elements, there are numerous disadvantages associated to this technique, including extended surgical time, local pain and swelling from donor segments.
The use of synthetic substitutes, like calcium phosphate cements, have significant advantages, including decreased risk of infection from human pathogens, and unlimited availability in various shapes and sizes. Thus, reconstruction and/or filling of bone defects caused by trauma, disease, or tumour resection in long bones using calcium phosphate cements has proven to be an effective and safe alternative to reduce donor-site morbidity associated to autografting, whilst providing support for bone regeneration.
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
- Bone graft substitute patients who underwent surgery with Neocement and meet the eligibility criteria.
Key inclusion criteria (5 listed)
- Patients with bone defect treatment who meet predefined criteria in Instructions For Use (IFU) of Neocement® / Neocement® Inject P.
- Age ≥ 18 years of both genders (male and female)
- Patient signed informed consent form (for data collection)
- Bone defects surgically created or osseous defects created from traumatic injury to the bone
- Bone skeletal defects that are not intrinsic to the stability of bone structure OR site which can be stabilized
Key exclusion criteria (7 listed)
- Acute or chronic infection at the surgical site;
- Metabolic bone diseases;
- Severe degenerative disease conditions in which general bone grafting is not advisable;
- Active malignancy.
- Inability to understand consent and objectives of the study;
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 |
|---|---|---|
| NeocementAlso: Neocement Inject PBone graft substitutes | Device | – |
Primary outcome
Bone consolidation (Neer/ RUST classification)
Time frame: 24 months
Neer classification is used for trabecular bone: Healed: Cyst filled by new bone, with or without small radiolucent area(s) < 1 cm in size Healing with defects: Radiolucent area(s) < 50% of the diameter of bone, with enough cortical thickness to prevent fracture Persistent cyst: Radiolucent area > 50% of diameter of the bone and with a thin cortical rim. No increase in the size of the cyst. Recurrent cyst: Cyst reappeared in a previously obliterated area, or a residual radiolucent area has increased in size) RUST is classified according to the scores: Score 1: Fracture Line, No Callus Score 2: Fracture Line, Visible Callus Score 3: Fracture Line, Bridging Callus Score 4: No fracture line, remodelled
1 secondary outcome
Functional scores
Time frame: 24 months
Results and safety
The study was stopped early (reason given: The study was terminated following a change in company management.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 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. This study is not recruiting at the moment.
Nuno Ribeiro, M. Doctor study chair
Hospital Lusíadas Lisboa
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 Deformity, 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 7 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: stopped early, as of the sponsor's last update on 31 Jan 2025. 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?
The study was stopped early (reason given: The study was terminated following a change in company management.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone consolidation (Neer/ RUST classification) (time frame: 24 months). 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 Jan 2025.