The purpose of this study is to evaluate whether patients with trochanteric fractures being treated with a Proximal Femoral Nail Antirotation (PFNA) and augmentation can better be mobilized than patients without augmentation.
Who can participate
Age range
75 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:
* Age 75 years and older
* Closed unstable trochanteric fracture: AO 31 - A2 and A3
* Low energy trauma (e.g.fall from standing height)
* Definitive fracture fixation within 72 hrs. after admission
* Indication for PFNA fixation (with or without augmentation)
* Ability to walk independently (walking aids are allowed) prior to injury
* Signed written informed consent and agreement to attend the planned FUs
* Able to understand and read country national language at an elementary level
Exclusion Criteria:
* Pathologic fracture
* Polytrauma
* Any additional fracture
* Open fracture
* Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
* Active malignancy defined as history of invasive malignancy, except if the patient has received treatment and displayed no clinical signs and symptoms for at least five years
* ASA class V and VI
* Any implant at the same hip
* Hemiplegia
* Patients with legal guardian
* Patients who have participated in any other device or drug related clinical trial that could influence the results of the present study within the previous month
* Fractures and injuries opening into the articulation and vascular structure
* Infection
* Patients with clotting disorders
* Patients with severe cardiac and / or pulmonary insufficiency
* Patients with known hypersensitivity or allergy to any of the components of Traumacem V+ cement (Polymethyl methacrylate / acrylate, zirconium dioxide, hyd…
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
Mobility measured with the "timed up & go"-test during hospital stay.
Timeframe: 5 to 7 days postoperative
Trial details
NCT IDNCT01473082
SponsorAO Clinical Investigation and Publishing Documentation