Retrospective Study Chimaera Long Nail in Adult Patient

NCT ID: NCT06285981

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 44 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-27
• Study Completion Date: 2024-12-18

Brief Summary

The CHIMERA study intends to evaluate the clinical benefits of the study medical device in the standard clinical practice.

Detailed Description

The CHIMERA study intends to evaluate the clinical benefits of the study medical/investigational device in the standard clinical practice. The study will be conducted in two sites located in Italy; both considered reference sites for the treatment of adult patients with pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur, where the usage of Orthofix® Chimaera Hip Fracture SystemTM (from now on CHIMAERA) was part of the normal clinical practice. The CHIMAERA, is an internal fixation system intended for insertion into the medullary canal of a femur in individuals suffering from stable and unstable pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur alone or when these fractures occur in combination with shaft fractures extending distally to a point approximately 10cm proximal to the intercondylar notch. The participant investigators will retrospectively include a maximum of 44 patients meeting inclusion and exclusion criteria (considering an imprecision of 5%) that will contribute for approximately 44 patients in which CHIMAERA was used.

The study is designed to analyze medical records of adult patients who underwent CHIMAERA implantation from 2018 to 2023 in the standard clinical practice setting.

Conditions

Pertrochanteric Fracture of Femur; Intertrochanteric Fracture of Femur; Subtrochanteric Fracture of Femur

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

patients with femur fractures

adult patients with pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur

Chimaera Long Nail

Intervention Type: DEVICE

The CHIMAERATM, is an internal fixation system intended intended for insertion into the medullary canal of a femur in individuals suffering from stable and unstable pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur alone or when these fractures occur in combination with shaft fractures extending distally to a point approximately 10cm proximal to the intercondylar notch.

Interventions

Chimaera Long Nail

The CHIMAERATM, is an internal fixation system intended intended for insertion into the medullary canal of a femur in individuals suffering from stable and unstable pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur alone or when these fractures occur in combination with shaft fractures extending distally to a point approximately 10cm proximal to the intercondylar notch.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. The patient expressed his willingness to participate in the Study by signing and dating informed consent.

2. Patients who had a regular indication for surgical intervention with the long variant of CHIMAERATM according to the manufacturer's IFU.

3. Patients equal or older than 18 years at the time of surgery.

4. Patients who underwent surgery performed with CHIMAERATM.

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. Patient who had/has a medical condition that is a contraindication according to the manufacturer's IFU leaflet.

2. Patient has been diagnosed with bilateral proximal femur fractures.

3. Patient who needed the application of, or ha already in-situ a concomitant not permitted device which cannot be safely removed.

4. Patient with other concurrent medical or non-medical condition that in the opinion of the participating investigator may prevent participation or otherwise render the patient ineligible for the study.

5. The patient is participating in other clinical studies, or he/she has participated in other clinical studies in the 3 months prior signing the informed consent .

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orthofix s.r.l.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AORN Sant'Anna e San Sebastiano

Caserta, CE, Italy

Craeggi Hospital

Florence, FI, Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

OCI_2206

Identifier Type: -

Identifier Source: org_study_id