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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.
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galaxy Fixation System and Orthofix implantable devices | Device | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | average of 2 months |
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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:
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Alessando Casiraghi, MD | Spedali Civili di Brescia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spedali Civili di Brescia | Brescia | 25123 | Italy | |||
| Ospedale Niguarda Ca' Granda di Milano |
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| Milan |
| 20162 |
| Italy |
| Ospedale di Vicenza | Vicenza | 36100 | Italy |