Observational Clinical Study on Elderly Patients With Fracture of the Proximal Femur Treated With… (NCT05197335) | Clinical Trial Compass
CompletedNot Applicable
Observational Clinical Study on Elderly Patients With Fracture of the Proximal Femur Treated With the Chimaera Nail
Italy206 participantsStarted 2020-07-09
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ha…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.