RecruitingOBSERVATIONAL

ZNN Bactiguard Antegrade Femoral Nails PMCF Study

This study is gathering information on a special implant called the ZNN Bactiguard Antegrade Femoral Nail. This nail is already available and used by surgeons to fix broken thigh bones (femur fractures) or for bone cuts (osteotomies). The main goal is to see how safe and effective this nail is, and how well patients recover. Researchers will observe how quickly bones heal, how many problems might occur, and what patients themselves report about their recovery and comfort. This is a "post-market" study, meaning the device is already in use, and the study helps make sure it continues to meet safety and performance standards for patients in the UK and Europe. If you've had this nail put in, you might be asked to take part.

At a glance

Status

Recruiting

Sponsor

Zimmer Biomet

Enrolment target

100

Start

16 Jan 2024

Estimated completion

01 Dec 2027

Femur Fracture Osteotomy

What is this study about?

This study is looking closely at a specific medical device called the ZNN Bactiguard Antegrade Femoral Nail. This is a type of 'nail' or rod that surgeons insert inside the thigh bone (femur) to help it heal after a break (fracture) or a planned surgical cut to the bone (osteotomy). It's designed to hold the bone steady while it mends. This particular nail is already approved for use and available in hospitals, which means it has already met certain safety standards.

The main purpose of this study is to collect more information about how this nail performs in real patients. Researchers want to confirm its safety and effectiveness over time. They will be checking things like how well the bone heals, whether patients experience any pain or problems, and if there are any infections related to the surgery. This helps ensure that the device continues to be reliable and beneficial for people needing this type of surgery.

Over the course of about a year, doctors will collect information at different times after your surgery. This helps them understand the healing process and how you're feeling. About 100 patients across several hospitals in Europe will take part. This type of study is important because it helps keep track of how medical devices work after they've been released for general use, making sure they continue to be a good choice for patients.

Key takeaways

This study is about a special nail used to fix broken thigh bones or for bone surgery.
The nail (ZNN Bactiguard Antegrade Femoral Nail) is already in common use.
The study aims to check how safe and effective the nail is over time.
It involves collecting information at follow-up visits for about a year after your surgery.
Your contribution helps improve care for future patients.

Who may be eligible?

To be able to join this study, you must be 18 years old or older. You would have either broken your thigh bone (femur) or had a special bone cut called an osteotomy, and your doctor decided to fix it using this specific ZNN Bactiguard Antegrade Femoral Nail. You also need to be able to understand what taking part means and be willing to attend follow-up appointments.

There are also reasons why you might not be able to join. For example, if your bones are still growing, or if you have certain other health problems like a bad infection or poor blood flow that could affect your recovery. If your thigh bone isn't suitable for this type of nail, or if you're pregnant or breastfeeding, or if the medical team thinks you might struggle to keep up with the study appointments, you wouldn't be able to participate. Your doctor will carefully check if this study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you broken your thigh bone or had a bone cut (osteotomy) that needs this specific nail?
Are you able to attend follow-up appointments for about a year?
Do you understand what taking part in a study means and are you willing to sign a consent form?

Answer every question to see your result.

What does participation involve?

If you are invited to take part in this study, you won't be given any new medication that's specifically for the study. Instead, the focus is on monitoring your recovery after you've had the ZNN Bactiguard Antegrade Femoral Nail implanted. Data will be collected at several follow-up visits after your surgery – typically around 6 weeks, 3 months, 6 months, and then 1 year later. During these visits, your doctor will check how your bone is healing using X-rays, and you might be asked to fill out questionnaires about your pain, how you're moving, and your overall recovery. The full duration of your direct involvement would be about one year after your initial surgery.

Potential risks and benefits

Taking part in this study primarily involves allowing researchers to collect information about your recovery from a treatment you've already received (or are about to receive). The potential benefit is contributing to a better understanding of how this device works for patients, which can help others in the future. As the device is already in use, the direct risks are generally those associated with the standard procedure itself, and not specifically from being in the study. Potential risks of any surgery include infection or complications, which the study will monitor closely. You always have the right to withdraw from the study at any time without affecting your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Hospital Universitario Nuestra Señora de Candelaria
Verified postcode
Santa Cruz de Tenerife, Spain· Active not recruiting
Manchester Royal Infirmary
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What is a 'femur fracture'?

It's a break in your thigh bone, which is the longest and strongest bone in your body.

What is an 'osteotomy'?

It's a surgery where a surgeon cuts a bone, often to correct a deformity or to relieve pressure on a joint.

What does 'post-market' mean?

It means the medical device (the nail) is already approved and used in patients, and this study is gathering more information on how it works in real-world settings.

Will I get a different treatment if I join?

No, you will receive the standard treatment using the ZNN Bactiguard Antegrade Femoral Nail, and the study will just collect information about your recovery.

What does 'CE-marked' mean?

It's a mark on products that means they've met European safety, health, and environmental protection standards and can be sold legally in the EU/UK.

How to find out more

Gemma de Ramon Francàs

gemma.deramonfrancas@zimmerbiomet.com +41 79 377 11 96 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.