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

Active, not recruitingOBSERVATIONAL
Enrollment

118

Participants

Timeline

Start Date

September 23, 2024

Primary Completion Date

March 31, 2025

Study Completion Date

March 31, 2025

Conditions
Fractures of the Long BonesVertically Stable Pelvic FracturesVertically Unstable Pelvic Fractures
Interventions
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."

Trial Locations (3)

20162

Ospedale Niguarda Ca' Granda di Milano, Milan

25123

Spedali Civili di Brescia, Brescia

36100

Ospedale di Vicenza, Vicenza

All Listed Sponsors
lead

Orthofix s.r.l.

INDUSTRY

NCT06690437 - Observational Study for the Evaluation of the Clinical Performance and Safety Profile of the GALAXY FIXATION™ System and Orthofix Implantable Devices: GALAXY Study | Biotech Hunter | Biotech Hunter