N-Force Screws Augmented With N-Force Blue in Hip Fractures (NCT03807349) | Clinical Trial Compass
TerminatedNot Applicable
N-Force Screws Augmented With N-Force Blue in Hip Fractures
Stopped: Sponsor will not pursue CE mark for this product, which precludes need for large PMCF study.
United States12 participantsStarted 2019-02-21
Plain-language summary
The objective of this prospective study is to confirm safety and performance of N-Force Screws augmented with N-Force Blue applied in intracapsular proximal femur fracture treatment.
Who can participate
Age range
50 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:
* Patient has primary Garden I or II intracapsular proximal femur fracture requiring surgical intervention and is eligible for fixation by three cannulated screws augmented with N-Force Blue.
* Patient receives operative treatment within 7 days of injury.
* Patient was ambulatory before injury.
* Patient is 50 years of age or older.
Exclusion Criteria:
* Patient has Garden III or IV intracapsular proximal femur fracture.
* Patient has major cognitive impairment (including dementia).
* Patient is on dialysis.
* Patient is not expected to survive follow-up schedule.
* Patient is expected to have problems maintaining follow-up compliance, i.e. patients with no fixed address, patients not mentally competent to give informed consent, etc. (Investigator's discretion).
* Patient is a prisoner.
* Patient is known to be pregnant and/or breastfeeding.
* Patient is a known alcohol or drug abuser.
* Patient had previous/has active acute or chronic infections, especially at the site of operation.
* Patient has non-viable bone, or has areas where surrounding bone is not viable or capable of supporting and anchoring the implant.
* Patient has traumatic injuries with open wounds or close to the proximal femur fracture, which are likely to become infected.
* Patient is expected to be non-compliant with recommended post-operative weight-bearing instructions.
* Physical conditions, in the opinion of the investigator, that would prohibit adequate implant support or impede …
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.