RecruitingOBSERVATIONAL

Zimmer® Natural Nail® (ZNN) Bactiguard Tibia Post-Market Clinical Follow-up Study

This study is looking at a new type of metal pin, called ZNN Bactiguard, used to mend broken shin bones. These pins have a special coating designed to help reduce infections after the bone has been fixed. Researchers want to compare the rate of infection in patients who receive the ZNN Bactiguard pin with those who receive a standard, uncoated metal pin. They will follow patients for 12 months after their operation to see if the coated pins lead to fewer infections. The study will also check how well the coated pins work, how safe they are, and if they improve patients' quality of life and recovery. This vital research aims to find better ways to help people heal from shin bone fractures with fewer complications.

At a glance

Status

Recruiting

Sponsor

Zimmer Biomet

Enrolment target

500

Start

11 Apr 2022

Estimated completion

01 Jul 2027

Tibial Fractures Fracture Infection

What is this study about?

When you break a shin bone (tibial fracture), doctors often use a metal pin, also known as a nail, placed inside the bone to help it heal properly. Unfortunately, sometimes these operations can lead to infections. This study is investigating a new type of metal pin called ZNN Bactiguard. This pin has a special coating that's designed to protect against germs and reduce the risk of infection after surgery.

The main goal of this research is to see if the ZNN Bactiguard pin leads to fewer infections compared to the standard, uncoated metal pins currently used. Researchers will carefully track patients for a year after their fracture has been fixed. They also want to make sure the ZNN Bactiguard pin is safe, works well to help the bone heal, and improves patients' overall recovery and quality of life.

This study is important because reducing infections after surgery can make a big difference for patients, helping them recover more smoothly and avoid further problems. By comparing the new coated pins with standard ones, doctors hope to find better ways to care for people with broken shin bones.

Key takeaways

This study compares a new protective coating on shin bone pins.
It aims to see if the new coating reduces infections after fracture surgery.
The study also checks safety, healing, and quality of life.
Participants are followed for 12 months after their operation.
The research helps doctors find better ways to treat broken shin bones.

Who may be eligible?

To be able to take part in this study, you must be 18 years old or older. You would have had a broken shin bone (tibia fracture) that doctors consider at higher risk of infection, and it would need to be fixed with an internal metal pin. This often includes certain types of open fractures (where the bone breaks through the skin), fractures initially treated with external frames due to swelling, or fractures with severe soft tissue damage.

If you are being considered for the ‘new pin’ group, you will receive the ZNN Bactiguard pin. If you are in the ‘standard pin’ group, information will be gathered from your existing medical records if you have already had an uncoated metal pin inserted. You wouldn’t need to undergo any extra procedures for this part of the study.

You wouldn't be able to join if you are unable or unwilling to give your consent, or if doctors don't expect you to complete the study follow-up. This also applies if you are pregnant or breastfeeding, have a history of certain mental or neurological conditions, or if your fracture is due to a disease that weakens bones, is extremely severe (specific Gustilo Type IIIC), or requires extensive additional fixation beyond an internal pin.

Quick self-check

Are you 18 years old or older?
Do you have a broken shin bone that requires internal pin fixation?
Is your fracture considered higher risk for infection?
Could you attend follow-up appointments for up to 1 year?
Are you able and willing to give your informed consent?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you participate in this study, doctors will collect information from you at different times. If you receive the new ZNN Bactiguard pin, you will have follow-up appointments at about 2 weeks, 3 months, 6 months, and 1 year after your fracture surgery. At these visits, doctors will check how your bone is healing with X-rays, assess your knee function and overall quality of life through questionnaires, and monitor for any side effects or complications. If you are part of the control group (meaning you received a standard pin in the past), information will be taken directly from your medical records, and you generally won't need to attend extra study visits. The total duration of follow-up for monitoring the fracture and outcomes is 12 months.

Potential risks and benefits

Potential benefits of taking part could include using a new device designed to reduce infection, which might lead to a smoother recovery. However, there's no guarantee you will personally benefit. Potential risks are generally similar to those associated with any shin bone fracture surgery, including the risk of infection, issues with bone healing, or reactions to the implant. The study closely monitors for any adverse events. If you decide to take part, you are free to withdraw from the study at any time without affecting your medical care.

Locations (16)

Tirolkliniken Innsbruck
Innsbruck, Austria· Recruiting
Hôpital Ambroise-Paré
Boulogne-Billancourt, France· Recruiting
Hôpitaux Universitaires de Marseille Nord
Marseille, France· Recruiting
Universitätsklinikum Marburg
Marburg, Germany· Recruiting
Universitätsklinikum Leipzig
Leipzig, Germany· Recruiting
Universitätsklinikum Regensburg
Regensburg, Germany· Recruiting
AOU Policlinico di Bari
Bari, Italy· Recruiting
Azienda Ospedaliero-Universitaria Careggi
Florence, Italy· Recruiting
Tygerberg Hospital
Cape Town, South Africa· Recruiting
Groote Schuur Hospital
Cape Town, South Africa· Recruiting
Hospital Universitario Valle de Hebrón
Barcelona, Spain· Recruiting
Kantonsspital Winterthur
Winterthur, Switzerland· Recruiting

+4 more sites — see the official record for the full list.

Common questions

What is a 'tibial fracture'?

A tibial fracture is a break in your shin bone, which is one of the two long bones in your lower leg.

What is an 'intramedullary nail'?

It's a metal rod or pin inserted into the hollow centre of a bone to help hold the broken pieces together so they can heal.

What is 'ZNN Bactiguard'?

ZNN Bactiguard is a specific type of metal pin used for shin bone fractures that has a special coating designed to help prevent infections.

Why is 'infection' a concern after fracture surgery?

Infections after surgery can delay healing, cause more pain, and sometimes require additional treatments or operations.

How long will I be followed up in the study?

If you receive the new pin, you will be followed up for 12 months after your surgery to monitor your recovery and the healing of your fracture.

How to find out more

Gemma de Ramon Francas

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.