Observational Study for the Evaluation of the Clinical Performance and Safety Profile of the GALA… (NCT06690437) | Clinical Trial Compass
TerminatedNot Applicable
Observational Study for the Evaluation of the Clinical Performance and Safety Profile of the GALAXY FIXATION™ System and Orthofix Implantable Devices: GALAXY Study
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.
Italy3 participantsStarted 2025-10-21
Plain-language 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. 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.
Who can participate
Age range
29 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The clinical performance of GALAXY FIXATION™ System and Orthofix implantable devices.
. 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