Observational Study for the Evaluation of the Clinical Performance and Safety Profile of the GALA… (NCT06690437) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Observational Study for the Evaluation of the Clinical Performance and Safety Profile of the GALAXY FIXATION™ System and Orthofix Implantable Devices: GALAXY Study
Italy118 participantsStarted 2024-09-23
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 range29 Days
SexALL
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
âś“. 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:
âś“. Patients equal or older than 29 days.
âś“. Patients who had a regular indication for external fixation according to the investigator criteria.
âś“. Patients with clinical data registered in her/his medical records sufficient to assess the safety and efficacy endpoints of the study
Exclusion criteria
âś•. 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.
âś•. 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.
What they're measuring
1
The clinical performance of GALAXY FIXATION™ System and Orthofix implantable devices.