Retrospective Study Chimaera Long Nail in Adult Patient

Last updated: May 8, 2025
Sponsor: Orthofix s.r.l.
Overall Status: Completed

Phase

N/A

Condition

Osteoporosis

Treatment

Chimaera Long Nail

Clinical Study ID

NCT06285981
OCI_2206
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  2. Patients who had a regular indication for surgical intervention with the longvariant 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 toassess the safety and efficacy endpoints of the study.

Exclusion

Exclusion Criteria:

  1. Patient who had/has a medical condition that is a contraindication according to themanufacturer'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 notpermitted device which cannot be safely removed.

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

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

Study Design

Total Participants: 44
Treatment Group(s): 1
Primary Treatment: Chimaera Long Nail
Phase:
Study Start date:
November 27, 2023
Estimated Completion Date:
December 18, 2024

Study 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.

Connect with a study center

  • AORN Sant'Anna e San Sebastiano

    Caserta, CE 81100
    Italy

    Site Not Available

  • Craeggi Hospital

    Florence, FI 50134
    Italy

    Site Not Available

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