Influence of Cemented Cephalic Augmentation on the Outcome of Intramedullary Nailing in Pertrocha… (NCT06634290) | Clinical Trial Compass
RecruitingNot Applicable
Influence of Cemented Cephalic Augmentation on the Outcome of Intramedullary Nailing in Pertrochanteric Hip Fractures
Spain314 participantsStarted 2024-09-30
Plain-language summary
The goal of this clinical trial is to learn if small modifications in the surgical technique for the treatment of some kind of hip fractures, improve the result of the surgery. This small modification includes the addition of surgical bone cement to part of the intramedullary nail used in the surgery, to find out if it provides more stability to the construct and represents an improvement in the surgery result.
The main question it aims to answer is:
Does the addition of bone cement produces a decrease in complications related to mechanical failure of the implant used in the surgery and a decrease in the need for re-operation?
Researchers will compare adding this bone cement to the standard surgical technique without it.
Patients will:
* Be randomly assigned to a group that will have surgery following standard protocol or to a group that will have surgery following standard protocol but adding bone cement to the construct.
* Receive standard care for these fractures during hospitalization and posterior follow-up checkups for a year.
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:
* 75 years of age or older.
* Diagnosis with a pertrochanteric fragility fracture.
* Informed consent for participation in the study.
Exclusion Criteria:
* Not meeting the inclusion criteria described above.
* Refusal of the patient or his/her legal representative to participate in the study.
* Diagnosis with hip fracture of subtypes other than 31A1, 31A2, 31A3 and 31B3 of AO-OTA classification.
* Bilateral hip fractures in the same episode.
* Suffering from previous medical pathologies or comorbidities that contraindicate surgical intervention and indicate conservative management of the fracture.
* Performing a surgical technique different from intramedullary nailing or using a surgical implant different from that used in the present 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
Mechanical failure rate of the implant
Timeframe: From date of surgery until the date of mechanical failure diagnosis, assessed up to 52 weeks