Retrospective Study Chimaera Long Nail in Adult Patient

NCT06285981 | Completed Results

• 1 other identifier: OCI_2206
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

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

Keywords

intramedullary nail; chimaera; orthofix; fractures; femur

Outcome Measures

Primary Outcomes (1)

• Percent of Patients in Which Bone Union Has Been Achieved

  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.

  12 months

Secondary Outcomes (1)

• Percent of Patients That Required a Reoperation

  6 months

Study Arms (1)

patients with femur fractures

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

Device: Chimaera Long Nail

Interventions

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.

patients with femur fractures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults suffering from pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur, where the usage of Orthofix® Chimaera Hip Fracture SystemTM (from now on CHIMAERATM) was part of the normal clinical practice.

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Orthofix s.r.l.: lead

Study Sites (2)

AORN Sant'Anna e San Sebastiano

Caserta, CE, 81100, Italy

Location

Craeggi Hospital

Florence, FI, 50134, Italy

Location

MeSH Terms

Conditions

Hip Fractures; Fractures, Bone

Condition Hierarchy (Ancestors)

Femoral Fractures; Wounds and Injuries; Hip Injuries; Leg Injuries

Results Point of Contact

• Title: Clinical Program Manager
• Organization: Orthofix

danielacangiano@orthofix.it

0456719077

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: November 27, 2023
• Primary Completion: December 17, 2024
• Study Completion: December 18, 2024
• Last Updated: September 15, 2025
• Results First Posted: August 7, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)