Status:
UNKNOWN
Observational Clinical Study on Elderly Patients With Fracture of the Proximal Femur Treated With the Chimaera Nail
Lead Sponsor:
Orthofix s.r.l.
Conditions:
Hip Fractures
Subtrochanteric Fractures
Eligibility:
All Genders
65+ years
Brief 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 pl...
Detailed Description
Orthofix Srl has developed and placed on the European market the Chimaera Intramedullary Nail after having evaluated the clinical performance and safety of the medical device based on biomechanical te...
Eligibility Criteria
Inclusion
- directly or indirectly (through a respondent) will have expressed their will to participate in the study by signing and dating the informed consent;
- will have reached the age of 65 at the time of signing the informed consent;
- he/she will have been diagnosed with a fracture in the pertrochanteric, intertrochanteric or subtrochanteric region of the femur, stable or unstable, not previously treated;
- based on the investigator's judgment, he will have a regular indication for surgical treatment with an intramedullary nail;
- the fracture will be treated with the Chimaera short nail (length = 180 mm) and one or two telescopic lag screws, according to the manufacturer's instructions for use.
Exclusion
- will undergo surgery to treat the results of a previously treated fracture;
- he/she will have been diagnosed with a pathological fracture of oncological origin (primary tumor or skeletal metastasis);
- he/she will have been diagnosed with a fracture in the diaphyseal and/or distal region of the femur;
- he/she will have been diagnosed with an open fracture (type II and III according to the classification of Gustilo and Anderson) of the proximal femur;
- he/she will have been diagnosed with multiple fractures (including bilateral proximal femur fractures);
- in the pre-or intra-operative phase it will be decided to treat the fracture with the long version of the Chimaera nail and/or with non-telescopic cephalic screws (fixed length);
- will have a medical condition that constitutes a contraindication to treatment with Chimaera according to the manufacturer's instructions for use;
- will have a suspected or certified hypersensitivity/allergy to some component of the device that comes into contact with the patient;
- will present some clinical condition that, in the Investigator's opinion, could interfere with the procedures of the Clinical Investigation or that could jeopardize the safety of the patient;
- at the same time he will be treated with an unauthorized device that cannot be removed without endangering the safety of the patient;
- will be participating in other clinical trials or had participated in other clinical trials in the 3 months before signing the informed consent.
Key Trial Info
Start Date :
July 9 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2022
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT05197335
Start Date
July 9 2020
End Date
July 31 2022
Last Update
March 3 2022
Active Locations (8)
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1
Ospedale Regionale EE 'Miulli'
Acquaviva delle Fonti, BA, Italy, 70021
2
A.O. Sant'Anna e San Sebastiano Caserta
Caserta, CE, Italy, 81100
3
A.O.U. Policlinico - Vittorio Emanuele
Catania, CT, Italy, 95123
4
Ospedale S. Giuseppe
Empoli, FI, Italy, 50053