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 recruiting

• Conditions: Fractures of the Long Bones; Vertically Stable Pelvic Fractures; Vertically Unstable Pelvic Fractures

• Registration Number: NCT06690437
• Lead Sponsor: Orthofix s.r.l.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-23
• Status Verified: 2024-11
• Study First Submitted: 2024-11-13
• Study First Submitted QC: 2024-11-13
• Last Update Submitted: 2024-11-13
• Study First Posted: 2024-11-15
• Last Update Posted: 2024-11-15
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

1. The patient directly or indirectly (through a respondent) expressed his willingness to participate in the Study by signing and dating informed consent.

2. 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.

3. Patients equal or older than 29 days.

4. Patients who had a regular indication for external fixation according to the investigator criteria.

5. Patients with clinical data registered in her/his medical records sufficient to assess the safety and efficacy endpoints of the study

Exclusion Criteria

1. 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.
2. The patient needed the application of or had already in-situ concomitant devices that couldn't be safely removed (except for permitted concomitant devices).
3. The patient was treated with more than one GALAXY FIXATION™ System or non Orthofix implantable devices.
4. Patient who had mental or physiological conditions who are unwilling or incapable of following postoperative care instructions.
5. Patient who had previous infections in the fracture area.
6. Patients who had malignancy in the fracture area.
7. Patients who had neuromuscular deficit or any other conditions that could influence the healing process.
8. Patients who had suspected or documented metal sensitivity reactions as it could result in a treatment failure in the intended population

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The clinical performance of GALAXY FIXATION™ System and Orthofix implantable devices.	average of 2 months	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.

Trial Locations

Locations (3)

Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

Ospedale Niguarda Ca' Granda di Milano; 🇮🇹 Milano, Italy

Ospedale di Vicenza; 🇮🇹 Vicenza, Italy