NCT06285981

Retrospective Study Chimaera Long Nail in Adult Patient

Observational Retrospective Study to Assess the Clinical Benefit and Safety Profile of the Intramedullary Nail CHIMAERA in Adult Patient Who Have Suffered Pertrochanteric, Intertrochanteric and Subtrochanteric Fractures of the Femur in Daily Practice: CHIMAERA Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 44 (actual)
• Sponsor: Orthofix s.r.l. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2023-11-27
• Primary completion: 2024-12-17
• Completion: 2024-12-18
• First posted: 2024-02-29
• Last updated: 2025-09-15
• Results posted: 2025-08-07

Locations

2 sites across 1 country: Italy