Bone DefectTriOSSOrto01NCT07087509
Evaluation of the Safety and Performance of the TriOSS®: A Retrospective Observational Study in Orthopaedic Area
An observational study of Bone Defect and Orthopedic, 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 TriOSS® 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Defect, Orthopedic
- How many people
- 23 participants
- Where
- 1 sitePortugal
- Study dates
- 30 Sep 2025to 5 Jan 2026
- 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 consists of adult patients (> 18 years old) undergoing orthopaedic surgery after bone defect.
Who may be able to join
- Adult males or females (age > 18 years old);
- Patients with osseous defects, either of trauma origin, surgically created, or associated with spinal degenerative diseases that require segmental fusion of the spine.
- Patients with bone skeletal defects that are not intrinsic to the stability of the bone structure.
Who cannot join
- 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;
- 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.
About this study
This study aims to collect real-world clinical data to gather information on the performance and safety of the TriOSS® 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.
- Conditions
- Bone Defect, Orthopedic
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Endpoint
the success of bone consolidation on the surgery site, measured by X-ray. This includes radiological assessments (X-rays) to prove bone regeneration and assess the time required for bone consolidation.
Measured: Follow-up visits according to clinical practice and medical records: months post-surgery until a maximum of 24 months
Safety Endpoint
Assessment of AEs related to TriOSS® during the follow-up period of patients. Description of the event type, duration, determination of Serious Adverse Event (SAE) status, and follow-up of the adverse event.
Measured: Follow-up visits according to clinical practice and medical records, months post-surgery, until a maximum of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start30 Sep 2025
- Primary completion5 Jan 2026
- Study completion5 Jan 2026
Why it stopped: The study was terminated prematurely due to the inability to collect retrospective clinical data within the required contractual and regulatory deadlines. Although ethical approval was obtained, data collection was not performed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DefectStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioceramed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital dos Lusíadas
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087509
- Sponsor's protocol ID
- TriOSSOrto01
- Acronym
- TriOSSOrto01
- Status last verified
- Feb 2026
- First submitted
- 1 Jul 2025
- Last updated
- 4 Feb 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 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Performance of the TriOSS®: A Retrospective Observational Study in Orthopaedic Area
- ClinicalTrials.gov ID
- NCT07087509
- Acronym / sponsor ID
- TriOSSOrto01 / TriOSSOrto01
- Conditions
- Bone Defect, Orthopedic
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated prematurely due to the inability to collect retrospective clinical data within the required contractual and regulatory deadlines. Although ethical approval was obtained, data collection was not performed.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- BioceramedIndustry (pharma, biotech, devices)
- Collaborators
- Hospital dos Lusíadas
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 5 Jan 2026 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 28 Jul 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 TriOSS® 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (> 18 years old) undergoing orthopaedic surgery after bone defect.
Key inclusion criteria (3 listed)
- Adult males or females (age > 18 years old);
- Patients with osseous defects, either of trauma origin, surgically created, or associated with spinal degenerative diseases that require segmental fusion of the spine.
- Patients with bone skeletal defects that are not intrinsic to the stability of the bone structure.
Key exclusion criteria (8 listed)
- 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;
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: Follow-up visits according to clinical practice and medical records: months post-surgery until a maximum of 24 months
the success of bone consolidation on the surgery site, measured by X-ray. This includes radiological assessments (X-rays) to prove bone regeneration and assess the time required for bone consolidation.
Safety Endpoint
Time frame: Follow-up visits according to clinical practice and medical records, months post-surgery, until a maximum of 24 months
Assessment of AEs related to TriOSS® during the follow-up period of patients. Description of the event type, duration, determination of Serious Adverse Event (SAE) status, and follow-up of the adverse event.
Results and safety
The study was stopped early (reason given: The study was terminated prematurely due to the inability to collect retrospective clinical data within the required contractual and regulatory deadlines. Although ethical approval was obtained, data collection was not performed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Defect and Orthopedic, 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 8 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 4 Feb 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?
The study was stopped early (reason given: The study was terminated prematurely due to the inability to collect retrospective clinical data within the required contractual and regulatory deadlines. Although ethical approval was obtained, data collection was not performed.). 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?
Performance Endpoint (time frame: Follow-up visits according to clinical practice and medical records: months post-surgery until a maximum of 24 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 4 Feb 2026.