FNS (FEMORAL NECK SYSTEM) Study (NCT04577261) | Clinical Trial Compass
CompletedNot Applicable
FNS (FEMORAL NECK SYSTEM) Study
United States43 participantsStarted 2020-10-07
Plain-language summary
A post-market, prospective study to evaluate the reoperation rate of displaced and nondisplaced femoral neck fractures treated with the Femoral Neck System (FNS)™
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 subject must provide written informed consent
* The subject must be eighteen (18) years of age or older.
* The subject must be willing and able to make all required study visits including one (1) year post-operative follow-up.
* The subject must be able to follow instructions.
* Subject has experienced displaced or non-displaced intracapsular femoral neck fracture
Exclusion Criteria:
* Subject with fracture occurring more than 7 days prior to the date of surgery
* Subject has more than one fracture on target extremity.
* Subject is obese as defined by a Body Mass Index (BMI) \> 45 at the time of surgery.
* Subject, in the opinion of the Investigator, has an emotional or neurological condition that preludes cooperation and compliance with the rehabilitation regimen.
* Therapy with another investigational agent within thirty (30) days of Screening or planned therapy with another investigational agent during the course of the study.
* Subject has a physical condition that, in the opinion of the Investigator, would preclude adequate implant support or impede healing (e.g. blood supply impairment insufficient bone quality or quantity, or an active, local or systemic infection). If this is identified at the time of surgery, the subject will be screen failed.
* Subject has undergone previous surgery on the target hip.
* Current systemic therapy with cytotoxic drugs.
* Subjects with a history of poor compliance with medical treatment.
* Subjects with a me…
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.