RecruitingOBSERVATIONAL

ZNN Bactiguard Retrograde Femoral Nails PMCF Study

This study is checking on a treatment called the ZNN Bactiguard Retrograde Femoral Nail, which is a type of internal support used for broken thigh bones. It's a 'post-market' study, meaning the treatment is already in use, but doctors want to keep a close eye on how well it's working for patients. The main aim is to confirm that the treatment is safe and effective in helping your bone heal. They will also look at how patients recover and whether there are any infections related to the surgery. This helps ensure patients get the best possible care for their broken thigh bone.

At a glance

Status

Recruiting

Sponsor

Zimmer Biomet

Enrolment target

100

Start

23 Oct 2023

Estimated completion

01 Dec 2027

Femoral Fracture

What is this study about?

Imagine you've broken your thigh bone – that's your femur. It's a serious injury, and often needs surgery to help it heal properly. One way doctors fix these breaks is by putting a special rod, called an intramedullary nail, inside the bone to hold it steady. This study is specifically looking at a type of rod called the ZNN Bactiguard Retrograde Femoral Nail.

The study is called a 'post-market clinical follow-up' (PMCF) study. This means the ZNN Bactiguard nail is already being used by doctors, but researchers want to gather more information on how well it performs in real-world situations. Think of it like checking in on a new car model after it's been sold for a while, to make sure it's reliable and safe for drivers.

The main goal is to confirm that this particular nail is safe and helps your bone heal effectively. Researchers will be looking at how quickly and completely the broken bone mends, as well as checking for any problems or infections after the surgery. They'll also ask patients about their recovery and how they feel, to understand the overall benefits of the treatment.

Key takeaways

This study looks at a common treatment for broken thigh bones.
It's checking how well a specific internal rod (the ZNN Bactiguard nail) works.
The main goals are to confirm safety and help with fracture healing.
Participation involves routine follow-up after your surgery.
It helps gather important information for future patient care.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have a broken thigh bone that your doctors plan to treat with the ZNN Bactiguard Retrograde Femoral Nail. This includes different types of thigh bone breaks, whether the skin was broken or not, and even if you had a temporary external fixator first. You also need to be willing and able to attend all your follow-up appointments and understand what's involved in the study.

There are also reasons why someone might not be able to join. For example, if your bones are still growing, or if you have certain medical conditions that might affect the surgery or how your bone heals. You also can't participate if you have an active infection, or if you're unable to understand or agree to take part. Researchers also need to make sure you'll be able to complete all the necessary follow-up visits.

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?
Do you have a broken thigh bone that needs surgery?
Are doctors planning to use the ZNN Bactiguard nail for your treatment?
Are you able and willing to attend follow-up appointments?
Are you able to understand and give your consent to participate?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you'll be treated with the ZNN Bactiguard Retrograde Femoral Nail for your broken thigh bone, as planned by your surgeon. The study mostly involves your doctors collecting information during your standard care and follow-up appointments. They will check how your bone is healing, monitor for any complications, and ask you questions about your recovery and how you're feeling. This helps them understand the treatment's safety and effectiveness. The overall duration will depend on regular follow-up for this type of injury, but it generally means attending planned appointments for your fracture care.

Potential risks and benefits

The potential benefit of participating is knowing that your standard treatment will be closely monitored, contributing to important information about this implant for future patients. As this is a post-market study, the risks are generally those associated with standard surgery for a broken thigh bone and the use of this type of internal nail. Potential risks can include infection, issues with bone healing, or other complications that can occur with any surgery. You always have the right to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (4)

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

Hospital Universitario Ntra. Sra. de Candelaria
Verified postcode
Santa Cruz de Tenerife, Spain· Active not recruiting
Leeds General Infirmary
Verified postcode
Leeds, United Kingdom· Recruiting
Manchester Royal Infirmary
Verified postcode
Manchester, United Kingdom· Recruiting
Stepping Hill Hospital
Verified postcode
Stockport, United Kingdom· Active not recruiting

Common questions

What is a 'femoral fracture'?

A femoral fracture is the medical term for a broken thigh bone (femur), which is the longest and strongest bone in your body.

What is an 'intramedullary nail'?

It's a special rod inserted inside the hollow part of your bone to provide strong support and help a fracture heal properly from the inside.

What does 'post-market clinical follow-up' mean?

It means the treatment is already in use by doctors, and this study aims to gather more information on its safety and effectiveness in real patients after it's been approved.

Will I have extra appointments if I join this study?

The study mostly uses information collected during your routine follow-up appointments for your broken bone. There shouldn't be many, if any, additional visits solely for the study.

Who is funding this study?

The ZNN Bactiguard Retrograde Femoral Nail is made by Zimmer Biomet, so they would likely be the sponsor of this follow-up study.

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.