Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT05197335
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT05197335
Study Brief:
Protocol Section:
NCT05197335