MedTrace Logo

Observational Clinical Study on Elderly Patients With Fracture of the Proximal Femur Treated With the Chimaera Nail

NCT05197335 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 206

Last updated 2026-01-20

Study results available
· View outcomes & findings →

Summary

This is an observational, prospective and multicenter clinical investigation that is part of the active materiovigilance plan that Orthofix Srl, in agreement with its Notified Body. The sponsor has planned to actively collect clinical data relating to the use of Chimaera Intramedullary Nail in a representative number of users and elderly patients with fractures of the proximal femur. The data obtained from this clinical investigation will be used to complete the pre-market clinical evaluation carried out on the Chimaera with post-market clinical data from the use of the device in normal clinical practice.

Conditions

  • Hip Fractures
  • Subtrochanteric Fractures
  • Intertrochanteric Fractures
  • Pertrochanteric Fracture

Interventions

DEVICE

Chimaera short nail (length = 180 mm) in combination with one or two telescopic cephalic screws

The enrolled patients will proceed by undergoing the surgery necessary for the application of the medical device under observation (Chimaera), which coincides with the start of the treatment period.

Sponsors & Collaborators

  • Orthofix s.r.l.

    lead INDUSTRY

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-09
Primary Completion
2022-03-31
Completion
2022-07-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05197335 on ClinicalTrials.gov