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

NCT06690437 | Active Not Recruiting

• 1 other identifier: OCI_2204
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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: * 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.

Eligibility Criteria

• Age: 29 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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:
• fractures of the long bones or;
• Vertically stable pelvic fractures or vertically unstable pelvic fractures as a treatment adjunct.
• 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

You may not qualify if:

• 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.
• 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.
• Patient who had mental or physiological conditions who are unwilling or incapable of following postoperative care instructions.
• Patient who had previous infections in the fracture area.
• Patients who had malignancy in the fracture area.
• Patients who had neuromuscular deficit or any other conditions that could influence the healing process.
• Patients who had suspected or documented metal sensitivity reactions as it could result in a treatment failure in the intended population

Sponsors & Collaborators

• Orthofix s.r.l.: lead

Study Sites (3)

Spedali Civili di Brescia

Brescia, 25123, Italy

Location

Ospedale Niguarda Ca' Granda di Milano

Milan, 20162, Italy

Location

Ospedale di Vicenza

Vicenza, 36100, Italy

Location

Study Officials

• Alessando Casiraghi, MD

  Spedali Civili di Brescia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 15, 2024
• Study Start: September 23, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: November 15, 2024

Record last verified: 2024-11

Locations

IT (3)