Bone DefectsNCT04644536
Retrospective Collection of Safety and Performance Data
An observational study of Bone Defects, run by Bioceramed at 1 site in Portugal.
Trial summary
This is a retrospective post market clinical follow-up study to compile real world clinical data on safety and efficacy of the synthetic bone graft substitutes in a commercial clinical setting in long bone and extremity defects and in spinal fusion procedures. 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
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- 25 Nov 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: All study patients will be extracted from current patient population.
Who may be able to join
- Patients treated with Bioceramed bone substitutes at the Center.
- Long bone \& extremities: bone grafting after post-traumatic or surgically created bone defects.
- Spine: degenerative disc disease or trauma who require spinal fusion of 1 or more vertebral bodies.
Who cannot join
- Serious infection within two months before surgery, active malignancy, cellulitis, osteomyelitis, diseases interfering with bone metabolism (primary hyperparathyroidism, severe renal or hepatic insufficiency, non-treated hyperthyroidism), other bone metabolic diseases (osteomalacia, Paget disease, osteogenesis imperfecta), bone metastasis, primary bone tumors.
Trial locations and contacts
1 site in 1 country.
About this study
This is a retrospective post market clinical follow-up study to compile real world clinical data on safety and efficacy of the synthetic bone graft substitutes in a commercial clinical setting in long bone and extremity defects and in spinal fusion procedures.
- 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
Orthopaedic or Spine bony defects
| Study group | Role | What they receive |
|---|---|---|
| Granules in long bone & extremities | Filling of post-traumatic or surgically created bone defects Receives: Device: Bone graft substitute | |
| Wedges in long bone & extremities | Osteotomies with fixation Receives: Device: Bone graft substitute | |
| HA paste in long bone & extremities | Filling of post-traumatic or surgically created bone defects Receives: Device: Bone graft substitute | |
| Granules in Spine | Spinal cage filling Receives: Device: Bone graft substitute | |
| HA paste in Spine | Spinal cage filling Receives: Device: Bone graft substitute |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone healing, observable by x-ray/MRI
Primary endpoint will be successful radiographic bone repair.
Measured: 6 months
Bone healing, observable by x-ray/MRI
Primary endpoint will be successful radiographic bone repair.
Measured: 12 months
Secondary outcomes (1)
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 - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start25 Nov 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
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioceramed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nuno A Ribeiro, MD, Principal investigator, Hospital Lusíadas Lisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644536
- Sponsor's protocol ID
- 2020.09
- Status last verified
- Nov 2024
- First submitted
- 20 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
- Retrospective Collection of Safety and Performance Data
- ClinicalTrials.gov ID
- NCT04644536
- Acronym / sponsor ID
- 2020.09
- Conditions
- Bone Defects
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated following a change in company management.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- BioceramedIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 6 Nov 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 25 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 a retrospective post market clinical follow-up study to compile real world clinical data on safety and efficacy of the synthetic bone graft substitutes in a commercial clinical setting in long bone and extremity defects and in spinal fusion procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Granules in long bone & extremities | – | Device: Bone graft substituteFilling of post-traumatic or surgically created bone defects |
| Wedges in long bone & extremities | – | Device: Bone graft substituteOsteotomies with fixation |
| HA paste in long bone & extremities | – | Device: Bone graft substituteFilling of post-traumatic or surgically created bone defects |
| Granules in Spine | – | Device: Bone graft substituteSpinal cage filling |
| HA paste in Spine | – | Device: Bone graft substituteSpinal cage filling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All study patients will be extracted from current patient population.
Key inclusion criteria (3 listed)
- Patients treated with Bioceramed bone substitutes at the Center.
- Long bone \& extremities: bone grafting after post-traumatic or surgically created bone defects.
- Spine: degenerative disc disease or trauma who require spinal fusion of 1 or more vertebral bodies.
Key exclusion criteria (1 listed)
- Serious infection within two months before surgery, active malignancy, cellulitis, osteomyelitis, diseases interfering with bone metabolism (primary hyperparathyroidism, severe renal or hepatic insufficiency, non-treated hyperthyroidism), other bone metabolic diseases (osteomalacia, Paget disease, osteogenesis imperfecta), bone metastasis, primary bone tumors.
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 substituteOrthopaedic or Spine bony defects | Device | Granules in Spine, Granules in long bone & extremities, HA paste in Spine, HA paste in long bone & extremities, Wedges in long bone & extremities |
Primary outcome
Bone healing, observable by x-ray/MRI
Time frame: 6 months
Primary endpoint will be successful radiographic bone repair.
Bone healing, observable by x-ray/MRI
Time frame: 12 months
Primary endpoint will be successful radiographic bone repair.
1 secondary outcome
Number and description of any adverse event during the follow-up
Time frame: 6 - 12 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 3 inclusion and 1 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?
Bone healing, observable by x-ray/MRI (time frame: 6 months). 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 7 Nov 2024.