Real-world review of bone-fixation devices aims to confirm their safety and performance.
NCT ID NCT06690437
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks back at medical records of up to 118 patients in Italy who had surgery using the GALAXY FIXATION system or other Orthofix devices to stabilize fractures of the long bones (like the thigh or shin) or the pelvis. The goal is to see how well these devices hold the bones in place and help them heal in everyday hospital practice. No new treatments or tests are given—only existing data is reviewed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GALAXY FIXATION™ System and Orthofix implantable devices
- What this could lead to
- If successful, this study could confirm that these devices are safe and effective for stabilizing fractures in everyday medical practice.
- What could go wrong
- This is a small, retrospective study with only 118 patients, so results may not apply to everyone. It looks back at past data, not a controlled experiment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
3 people
The number who actually took part.
- Started
-
Oct 2025
- Finished
-
May 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
-
29 days and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. The patient directly or indirectly (through a respondent) expressed his willingness to participate in the Study by signing and dating informed consent. 2. 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. 3. Patients equal or older than 29 days. 4. Patients who had a regular indication for external fixation according to the investigator criteria. 5. Patients with clinical data registered in her/his medical records sufficient to assess the safety and efficacy endpoints of the study Exclusion Criteria: 1. 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. 2. The patient needed the application of or had already in-situ concomitant devices that couldn't be safely removed (except for permitted concomitant devices). 3. The patient was treated with more than one GALAXY FIXATION™ System or non Orthofix implantable devices. 4. Patient who had mental or physiological conditions who are unwilling or incapable of following postoperative care instructions. 5. Patient who had previous infections in the fracture area. 6. Patients who had malignancy in the fracture area. 7. Patients who had neuromuscular deficit or any other conditions that could influence the healing process. 8. Patients who had suspected or documented metal sensitivity reactions as it could result in a treatment failure in the intended population
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Fractures of the long bones are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Ospedale Niguarda Ca' Granda di Milano
Milan, 20162, Italy
-
Ospedale di Vicenza
Vicenza, 36100, Italy
-
Spedali Civili di Brescia
Brescia, 25123, Italy