NCT06690437

Observational Study for the Evaluation of the Clinical Performance and Safety Profile of the GALAXY FIXATION™ System and Orthofix Implantable Devices: GALAXY Study

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 118 (estimated)
• Sponsor: Orthofix s.r.l. · Industry
• Sex: All
• Age: 29 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Fractures of the Long Bones
• Vertically Stable Pelvic Fractures
• Vertically Unstable Pelvic Fractures

Interventions

Type	Name	Description
DEVICE	Galaxy Fixation System and Orthofix implantable devices	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.

Timeline

• Start date: 2024-09-23
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2024-11-15
• Last updated: 2024-11-15

Locations

3 sites across 1 country: Italy