Bone DefectsNCT04645186
Calcium Phosphate Cement As Bone Void Filler
An observational study of Bone Defects, run by Bioceramed at 1 site in Portugal.
Trial summary
This is an observational, prospective, non-randomised, post market clinical follow-up study to compile clinical data on performance and safety of the synthetic bone graft substitute and to assess that the performance and safety of the device are maintained until the reaching of its intended use in a commercial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Defects
- What is being tested?
- bone graft substitute
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 sitePortugal
- Study dates
- 5 Jan 2020to 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: The study population is considered as all the patients included in the study that meet the inclusion and exclusion criteria.
Who may be able to join
- Patients requiring bone grafting after post-traumatic or surgically created bone defects afflicting the long bones and extremities.
- Give written informed consent to participate in the study and be willing to comply with the protocol requirements.
- Able to verbalize and differentiate regarding the location and intensity of pain.
- Physical and mental availability to meet the clinical and radiographic follow-up schedule.
Who cannot join
- Serious infection within two months before surgery.
- Active malignancy, Cellulitis, Osteomyelitis, Osteomyelitis, Bone metastasis, Other bone metabolic diseases.
- Primary bone tumors and contraindications in performing an X-ray or CTscan.
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study.
- The subject is unable or not willing to complete follow-up visits and examination for the duration of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CALCIUM PHOSPHATE CEMENT AS BONE VOID FILLER - a Prospective Cohort Study in Patients Indicated for Long Bone and Extremity Surgery
This is an observational, prospective, non-randomised, post market clinical follow-up study to compile clinical data on performance and safety of the synthetic bone graft substitute and to assess that the performance and safety of the device are maintained until the reaching of its intended use in a commercial clinical setting in long bone and extremity defects.
- Conditions
- Bone Defects
- Being tested
- bone graft substitute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone graft substituteDevice
Filling bone defects in current clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Calcium Phosphate Cement (CPC) | Evaluation of CPC in long bone \& extremities Receives: Device: bone graft substitute |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological healing
Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST.
Measured: 3 months
Radiological healing
Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST.
Measured: 6 months
Radiological healing
Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST.
Measured: 9 months
Radiological healing
Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST.
Measured: 12 months
Radiological healing
Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST.
Measured: 18 months
Radiological healing
Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST.
Measured: 24 months
Secondary outcomes (6)
Number and description of any adverse event during the follow-up
Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute.
Measured: 3 months
Number and description of any adverse event during the follow-up
Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute.
Measured: 6 months
Number and description of any adverse event during the follow-up
Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute.
Measured: 9 months
Number and description of any adverse event during the follow-up
Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute.
Measured: 12 months
Number and description of any adverse event during the follow-up
Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute.
Measured: 18 months
Number and description of any adverse event during the follow-up
Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute.
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 posted27 Nov 2020
- Study start5 Jan 2020
- 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 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioceramed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidade Nova de Lisboa
- Responsible party
- Sponsor
- Investigators
- Nuno A Ribeiro, MD, Principal investigator, Hospital Lusíadas Lisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645186
- Sponsor's protocol ID
- 2019.04
- Status last verified
- Nov 2024
- First submitted
- 16 Nov 2020
- Last updated
- 7 Nov 2024
- 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 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CALCIUM PHOSPHATE CEMENT AS BONE VOID FILLER - a Prospective Cohort Study in Patients Indicated for Long Bone and Extremity Surgery
- ClinicalTrials.gov ID
- NCT04645186
- Acronym / sponsor ID
- 2019.04
- Conditions
- Bone Defects
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated following a change in company management.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BioceramedIndustry (pharma, biotech, devices)
- Collaborators
- Universidade Nova de Lisboa
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 6 Nov 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 27 Nov 2020 (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 is an observational, prospective, non-randomised, post market clinical follow-up study to compile clinical data on performance and safety of the synthetic bone graft substitute and to assess that the performance and safety of the device are maintained until the reaching of its intended use in a commercial clinical setting in long bone and extremity defects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Calcium Phosphate Cement (CPC) | – | Device: bone graft substituteEvaluation of CPC in long bone \& extremities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is considered as all the patients included in the study that meet the inclusion and exclusion criteria.
Key inclusion criteria (4 listed)
- Patients requiring bone grafting after post-traumatic or surgically created bone defects afflicting the long bones and extremities.
- Give written informed consent to participate in the study and be willing to comply with the protocol requirements.
- Able to verbalize and differentiate regarding the location and intensity of pain.
- Physical and mental availability to meet the clinical and radiographic follow-up schedule.
Key exclusion criteria (5 listed)
- Serious infection within two months before surgery.
- Active malignancy, Cellulitis, Osteomyelitis, Osteomyelitis, Bone metastasis, Other bone metabolic diseases.
- Primary bone tumors and contraindications in performing an X-ray or CTscan.
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study.
- The subject is unable or not willing to complete follow-up visits and examination for the duration 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 |
|---|---|---|
| bone graft substituteFilling bone defects in current clinical practice | Device | Calcium Phosphate Cement (CPC) |
Primary outcome
Radiological healing
Time frame: 3 months
Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST.
Radiological healing
Time frame: 6 months
Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST.
Radiological healing
Time frame: 9 months
Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST.
Radiological healing
Time frame: 12 months
Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST.
Radiological healing
Time frame: 18 months
Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST.
Radiological healing
Time frame: 24 months
Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST.
6 secondary outcomes
Number and description of any adverse event during the follow-up
Time frame: 3 months
Number and description of any adverse event during the follow-up
Time frame: 6 months
Number and description of any adverse event during the follow-up
Time frame: 9 months
Number and description of any adverse event during the follow-up
Time frame: 12 months
Number and description of any adverse event during the follow-up
Time frame: 18 months
Number and description of any adverse event during the follow-up
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 7 Nov 2024.
- 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 A Ribeiro, MD principal investigator
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 Defects, 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 4 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: stopped early, as of the sponsor's last update on 7 Nov 2024. 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?
Radiological healing (time frame: 3 months). The study lists 6 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 7 Nov 2024.