Fractures of the Long BonesNCT06690437
Observational Study for the Evaluation of the Clinical Performance and Safety Profile of the GALAXY FIXATION™ System and Orthofix Implantable Devices: GALAXY Study
An observational study of Fractures of the Long Bones and Vertically Stable Pelvic Fractures, run by Orthofix s.r.l. at 3 sites in Italy.
Trial summary
The GALAXY FIXATIONTM System and Orthofix implantable devices study intends to evaluate the clinical performance and safety profile of the study medical/investigational devices in the standard clinical practice. Read more about this study
- Who is it for?
- Ages 29 days and older
- Conditions the study is for
- Fractures of the Long Bones, Vertically Stable Pelvic Fractures, Vertically Unstable Pelvic Fractures
- What is being tested?
- Galaxy Fixation System and Orthofix implantable devices
- Type of treatment
- Medical device
- How many people
- 3 participants
- Where
- 3 sitesItaly
- Study dates
- 21 Oct 2025to 4 May 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 29 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: It is planned to include 118 patients in 3 sites in Italy treated with GALAXY FIXATION™ System and Orthofix implantable devices for the following indications: * fractures of the long bones or; * Vertically stable pelvic fractures or vertically unstable pelvic fractures as a treatment adjunct Clinical data will be collected only from patients with a regular indication for GALAXY FIXATION™ System and Orthofix implantable devices as per IFUs (no off-label use will be included) and who underwent surgery performed with the specific devices.
Who may be able to join
- The patient directly or indirectly (through a respondent) expressed his willingness to participate in the Study by signing and dating informed consent.
- Patient who had a regular indication for the following surgical intervention with the GALAXY FIXATION™ System and Orthofix implantable devices according to manufacturer's IFUs:
- fractures of the long bones or;
- Vertically stable pelvic fractures or vertically unstable pelvic fractures as a treatment adjunct.
- Patients equal or older than 29 days.
- Patients who had a regular indication for external fixation according to the investigator criteria.
- Patients with clinical data registered in her/his medical records sufficient to assess the safety and efficacy endpoints of the study
Who cannot join
- The patient is participating in other clinical studies or did he/she participate in the 3 months before signing the informed consent in other clinical studies.
- The patient needed the application of or had already in-situ concomitant devices that couldn't be safely removed (except for permitted concomitant devices).
- The patient was treated with more than one GALAXY FIXATION™ System or non Orthofix implantable devices.
- Patient who had mental or physiological conditions who are unwilling or incapable of following postoperative care instructions.
- Patient who had previous infections in the fracture area.
- Patients who had malignancy in the fracture area.
- Patients who had neuromuscular deficit or any other conditions that could influence the healing process.
- Patients who had suspected or documented metal sensitivity reactions as it could result in a treatment failure in the intended population
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Spedali Civili di Brescia
Brescia, 25123
Ospedale Niguarda Ca' Granda di Milano
Milan, 20162
Ospedale di Vicenza
Vicenza, 36100
About this study
Official title: Observational Retrospective Multicentric Study for the Evaluation of the Clinical Performance and Safety Profile of the GALAXY FIXATION™ System and Orthofix Implantable Devices in Patients Who Have Needed Bone Stabilization or Bone Fixation for Fractures of the Long Bones, Vertically Stable Pelvic Fractures, or Vertically Unstable Pelvic Fractures as a Treatment Adjunct in Daily Practice: GALAXY Study
The GALAXY FIXATIONTM System and Orthofix implantable devices study intends to evaluate the clinical performance and safety profile of the study medical/investigational devices in the standard clinical practice. The study will be conducted in three sites located in Italy considered reference sites for the treatment of adults and paediatric patients with fractures of the long bones, vertically stable pelvic fractures, or vertically unstable pelvic fractures as a treatment adjunct, where the usage of GALAXY FIXATION™ System and Orthofix implantable devices were part of the normal clinical practice. The participant investigators will retrospectively include a maximum of 118 patients in which GALAXY FIXATIONTM System and Orthofix implantable devices were used. No diagnostic or therapeutic intervention outside routine clinical practice will be applied.
- Conditions
- Fractures of the Long Bones, Vertically Stable Pelvic Fractures, Vertically Unstable Pelvic Fractures
- Being tested
- Galaxy Fixation System and Orthofix implantable devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galaxy Fixation System and Orthofix implantable devicesDevice
It is planned to include 118 patients in 3 sites in Italy treated with GALAXY FIXATION™ System and Orthofix implantable devices for the following indications:
- fractures of the long bones or;
- Vertically stable pelvic fractures or vertically unstable pelvic fractures as a treatment adjunct Clinical data will be collected only from patients with a regular indication for GALAXY FIXATION™ System and Orthofix implantable devices as per IFUs (no off-label use will be included) and who underwent surgery performed with the specific devices.
What is being measured
The primary outcome is the main question the study is designed to answer.
The clinical performance of GALAXY FIXATION™ System and Orthofix implantable devices.
It will be assessed by the percentage of patients in which GALAXY FIXATION™ System and Orthofix implantable devices have guaranteed the maintenance of reduction in temporary stabilization and the achievement of bone union in definitive fixation until the end of treatment.
Measured: average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start21 Oct 2025
- Primary completion4 May 2026
- Study completion4 May 2026
Why it stopped: The study was prematurely terminated by the Sponsor, Orthofix, following internal strategic organizational and budget assessments aligned with company priorities. The decision was not related to safety, data quality, or study conduct issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures of the Long BonesStudies 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthofix s.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alessando Casiraghi, MD, Principal investigator, Spedali Civili di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690437
- Sponsor's protocol ID
- OCI_2204
- Status last verified
- Jun 2026
- First submitted
- 13 Nov 2024
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Retrospective Multicentric Study for the Evaluation of the Clinical Performance and Safety Profile of the GALAXY FIXATION™ System and Orthofix Implantable Devices in Patients Who Have Needed Bone Stabilization or Bone Fixation for Fractures of the Long Bones, Vertically Stable Pelvic Fractures, or Vertically Unstable Pelvic Fractures as a Treatment Adjunct in Daily Practice: GALAXY Study
- ClinicalTrials.gov ID
- NCT06690437
- Acronym / sponsor ID
- OCI_2204
- Conditions
- Fractures of the Long Bones, Vertically Stable Pelvic Fractures, Vertically Unstable Pelvic Fractures
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was prematurely terminated by the Sponsor, Orthofix, following internal strategic organizational and budget assessments aligned with company priorities. The decision was not related to safety, data quality, or study conduct issues.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Orthofix s.r.l.Industry (pharma, biotech, devices)
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- 4 May 2026 (actual)
- Study completion
- 4 May 2026 (actual)
- First posted
- 15 Nov 2024 (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.
The GALAXY FIXATIONTM System and Orthofix implantable devices study intends to evaluate the clinical performance and safety profile of the study medical/investigational devices in the standard clinical practice. The study will be conducted in three sites located in Italy considered reference sites for the treatment of adults and paediatric patients with fractures of the long bones, vertically stable pelvic fractures, or vertically unstable pelvic fractures as a treatment adjunct, where the usage of GALAXY FIXATION™ System and Orthofix implantable devices were part of the normal clinical practice. The participant investigators will retrospectively include a maximum of 118 patients in which GALAXY FIXATIONTM System and Orthofix implantable devices were used. No diagnostic or therapeutic intervention outside routine clinical practice will be applied.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 29 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- It is planned to include 118 patients in 3 sites in Italy treated with GALAXY FIXATION™ System and Orthofix implantable devices for the following indications: * fractures of the long bones or; * Vertically stable pelvic fractures or vertically unstable pelvic fractures as a treatment adjunct Clinical data will be collected only from patients with a regular indication for GALAXY FIXATION™ System and Orthofix implantable devices as per IFUs (no off-label use will be included) and who underwent surgery performed with the specific devices.
Key inclusion criteria (7 listed)
- The patient directly or indirectly (through a respondent) expressed his willingness to participate in the Study by signing and dating informed consent.
- Patient who had a regular indication for the following surgical intervention with the GALAXY FIXATION™ System and Orthofix implantable devices according to manufacturer's IFUs:
- Patients equal or older than 29 days.
- Patients who had a regular indication for external fixation according to the investigator criteria.
- Patients with clinical data registered in her/his medical records sufficient to assess the safety and efficacy endpoints of the study
Key exclusion criteria (8 listed)
- The patient is participating in other clinical studies or did he/she participate in the 3 months before signing the informed consent in other clinical studies.
- The patient needed the application of or had already in-situ concomitant devices that couldn't be safely removed (except for permitted concomitant devices).
- The patient was treated with more than one GALAXY FIXATION™ System or non Orthofix implantable devices.
- Patient who had mental or physiological conditions who are unwilling or incapable of following postoperative care instructions.
- Patient who had previous infections in the fracture area.
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 |
|---|---|---|
| Galaxy Fixation System and Orthofix implantable devicesIt is planned to include 118 patients in 3 sites in Italy treated with GALAXY FIXATION™ System and Orthofix implantable devices for the following indications: * fractures of the long bones or; * Vertically stable pelvic fractures or vertically unstable pelvic fractures as a treatment adjunct Clinical data will be collected only from patients with a regular indication for GALAXY FIXATION™ System and Orthofix implantable devices as per IFUs (no off-label use will be included) and who underwent surgery performed with the specific devices. | Device | – |
Primary outcome
The clinical performance of GALAXY FIXATION™ System and Orthofix implantable devices.
Time frame: average of 2 months
It will be assessed by the percentage of patients in which GALAXY FIXATION™ System and Orthofix implantable devices have guaranteed the maintenance of reduction in temporary stabilization and the achievement of bone union in definitive fixation until the end of treatment.
Results and safety
The study was stopped early (reason given: The study was prematurely terminated by the Sponsor, Orthofix, following internal strategic organizational and budget assessments aligned with company priorities. The decision was not related to safety, data quality, or study conduct issues.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
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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.
Alessando Casiraghi, MD principal investigator
Spedali Civili di Brescia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fractures of the Long Bones and Vertically Stable Pelvic Fractures, run by Orthofix s.r.l. at 3 sites in Italy.
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 7 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 23 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 3 sites in Italy. 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 prematurely terminated by the Sponsor, Orthofix, following internal strategic organizational and budget assessments aligned with company priorities. The decision was not related to safety, data quality, or study conduct issues.). 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?
The clinical performance of GALAXY FIXATION™ System and Orthofix implantable devices. (time frame: average of 2 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 23 Jun 2026.