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Completed

NCT Number: NCT06285981

Retrospective Study Chimaera Long Nail in Adult Patient

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AORN Sant'Anna e San Sebastiano, Caserta, CE, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient expressed his willingness to participate in the Study by signing and dating informed consent.
  • Patients who had a regular indication for surgical intervention with the long variant of CHIMAERATM according to the manufacturer's IFU.
  • Patients equal or older than 18 years at the time of surgery.
  • Patients who underwent surgery performed with CHIMAERATM.
  • Patients with clinical data registered in her/his medical records sufficient to assess the safety and efficacy endpoints of the study.

Exclusion criteria

  • Patient who had/has a medical condition that is a contraindication according to the manufacturer's IFU leaflet.
  • Patient has been diagnosed with bilateral proximal femur fractures.
  • Patient who needed the application of, or ha already in-situ a concomitant not permitted device which cannot be safely removed.
  • 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.
  • 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 .

Treatment and study plan

Chimaera Long Nail

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.

Primary outcomes

  1. Percent of Patients in Which Bone Union Has Been Achieved

    Time frame: 12 months

    The clinical benefit of CHIMAERATM will be assessed by the percentage of patients in which bone union has been achieved within 12 months from the nail implant.

Secondary outcomes

  1. Percent of Patients That Required a Reoperation

    Time frame: 6 months

    The safety profile of CHIMAERATM will be assessed through the percentage of patients that required a reoperation (i.e., additional surgery).

Sponsors and collaborators

Lead sponsor

Orthofix s.r.l.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 29, 2024
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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