Retrospective Study Chimaera Long Nail in Adult Patient (NCT06285981) | Clinical Trial Compass
CompletedNot Applicable
Retrospective Study Chimaera Long Nail in Adult Patient
Italy44 participantsStarted 2023-11-27
Plain-language summary
The CHIMERA study intends to evaluate the clinical benefits of the study medical device in the standard clinical practice.
Who can participate
Age range
18 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
. The patient expressed his willingness to participate in the Study by signing and dating informed consent.
. Patients who had a regular indication for surgical intervention with the long variant of CHIMAERATM according to the manufacturer's IFU.
. Patients equal or older than 18 years at the time of surgery.
. Patients who underwent surgery performed with CHIMAERATM.
. Patients with clinical data registered in her/his medical records sufficient to assess the safety and efficacy endpoints of the study.
Exclusion criteria
. Patient who had/has a medical condition that is a contraindication according to the manufacturer's IFU leaflet.
. Patient has been diagnosed with bilateral proximal femur fractures.
. Patient who needed the application of, or ha already in-situ a concomitant not permitted device which cannot be safely removed.
. 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.
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.
What they're measuring
1
Percent of Patients in Which Bone Union Has Been Achieved
. 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 .