FARE Augmentation of Proximal Femoral Fractures With CaS/HA and Systemic ZA (NCT06135298) | Clinical Trial Compass
CompletedPhase 4
FARE Augmentation of Proximal Femoral Fractures With CaS/HA and Systemic ZA
Turkey (Türkiye)20 participantsStarted 2023-12-01
Plain-language summary
The goal of this clinical trial is to investigate the new bone formation around a metal device in the femoral head in patients with osteoporotic hip fractures undergoing surgical treatment with nails. These surgeries have a high risk of fixation failure in patients with osteoporosis due to low bone quality. The main question we aim to answer are whether promoting new bone formation around the implant is possible with a bone graft substitute (CERAMENT™ Bone Void Filler) and systemic osteoporosis drug (zoledronic acid) combination, which can strengthen the surgical fixation of the fracture. Participants will consist of patients suffering hip fracture and already scheduled for surgical treatment with a nail. One group will undergo conventional surgery. While the other group will also undergo the same surgery, they will receive CERAMENT™ Bone Void Filler around the implant as a short, extra step during surgery. This will allow the researchers to see whether new bone is formed during a 6-month follow-up.
Who can participate
Age range
65 Years – 90 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:
* Being between 65-90 years of age at the time of fracture
* Acute, unilateral proximal hip fracture (AO Foundation/Orthopaedic Trauma Association \[AO/OTA\]: A1 and A2) caused by low energy trauma
* Physical condition eligible for surgery with proximal femoral nail
* Having low mortality and high fracture risk according to Fracture and Mortality Risk Evaluation Index (FAME) classification
* Patient with communicative ability to understand the procedure and participate in the study and the follow-up program, consented to be included in the study and signed the consent form
Exclusion Criteria:
* Previous hip or pelvis fracture on the same side
* Concurrent corticosteroid treatment
* Concurrent medical osteoporosis treatment
* Irreversible coagulopathy or bleeding disorder.
o Note regarding reversible coagulopathies: Patients on coumadin or other anticoagulants may participate. Investigators will follow routine practices for perioperative discontinuation and re-initiation of anti-coagulants.
* Concurrent dialysis or elevated creatinine
* Presence of hypo- or hyper calcaemia
* History or active treatment due to malignancy involving the pelvis/hip area, including ongoing or completed radiotherapy
* Fractures involving acetabulum
* Active systemic infection or local skin infection at the incision site
* Known hyperthyroidism or thyroid adenoma,
* History of serious reaction to iodine-based radio contrast agents
* Patient without communicative ability to u…
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
Change of bone density around the helical blade of proximal femoral nail
Timeframe: 1-week and 6 months after the surgery
2
Bone remodeling around the helical blade of proximal femoral nail