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

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

Study Overview

• Status: Recruiting
• Conditions: Pertrochanteric Fracture of Femur; Intertrochanteric Fracture of Femur; Subtrochanteric Fracture of Femur
• Intervention / Treatment: Device: Chimaera Long Nail

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.

• Study Type: Observational
• Enrollment (Estimated): 44

Contacts and Locations

• Study Contact: Name: Edo Knijff; Phone Number: +39-045-6719000; Email: edoknijff@orthofix.it

Study Locations

• Italy
  • CE
    • Caserta, CE, Italy, 81100
      • Not yet recruiting
      • AORN Sant'Anna e San Sebastiano
      • Contact: Gaetano Bruno; Phone Number: 0823 232111
  • FI
    • Florence, FI, Italy, 50134
      • Recruiting
      • Craeggi Hospital
      • Contact: Roberto Civinini; Phone Number: 055 794 111

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

1. The patient expressed his willingness to participate in the Study by signing and dating informed consent.
2. Patients who had a regular indication for surgical intervention with the long variant 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 to assess the safety and efficacy endpoints of the study.

Exclusion Criteria:

1. Patient who had/has a medical condition that is a contraindication according to the manufacturer'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 not permitted device which cannot be safely removed.
4. 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.
5. 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 .

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percent of patients in wich 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
percent of patients that required a reoperation	The safety profile of CHIMAERATM will be assessed through the percentage of patients that required a reoperation (i.e., additional surgery).	6 months

Collaborators and Investigators

• Sponsor: Orthofix s.r.l.

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: fractures; femur; intramedullary nail; chimaera; orthofix
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Hip Injuries; Femoral Fractures; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: OCI_2206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No