At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- ZNN Bactiguard tibia (device)
- How long the study runs
- Study runs about 63 months (dates as stated)
- About the drug or intervention
- ZNN Bactiguard tibia — device: Tibia fracture fixation
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at two types of metal nail used to fix broken shin bones (tibial fractures) that are at high risk of infection. One nail, the Zimmer Natural Nail Bactiguard tibia nail, has a special coating, and it will be compared with a standard titanium nail without a coating. The study is run by Zimmer Biomet.
Who can take part
- Adults aged 18 or over.
- People with a main shin bone (tibia) fracture that is at high risk of infection and can be treated with a nail placed inside the bone.
- The fracture is at least one of these: an open break in the skin (including gunshot fractures) of certain severity; treatment was delayed because of swelling or severe injury; the leg had compartment syndrome needing a cut to release pressure; or a closed fracture with severe tissue damage.
- For the study group: the person will be treated with the ZNN Bactiguard tibia nail (joining after treatment is allowed up to the first follow-up visit).
- For the control group: the person was already treated with a standard titanium nail without the coating.
- The person has given informed agreement to take part where this is required.
Who may not be able to
- People unable or unwilling to give consent.
- People not expected to survive the follow-up schedule, or who are unlikely to follow the study plan.
- People with a mental or neurological condition, or alcohol or drug addiction, that prevents proper consent or taking part in follow-up.
- Prisoners.
- People who are pregnant or breastfeeding.
- Fractures that are: caused by disease (pathological); the most severe open type (Gustilo Type IIIC); broken into pieces not suitable for a nail; where the wound was closed more than 10 days after injury; needing a plate as well as the nail on the tibia (screws or a plate on the fibula bone are allowed); or happening alongside a serious head injury.
- For the control group: people missing any of the required records (personal details, injury type, infection information, operation report and device details, or X-ray results).
- People whose shin bone canal is blocked by an earlier fracture or tumour, or whose bone is too bent or deformed.
- People with too little bone or poor bone quality for the nail to sit firmly, poor blood supply, or other illnesses that could affect the operation or the nail.
- People with an existing infection, or who are still growing.
What taking part involves
- • The study nail: a Zimmer Natural Nail Bactiguard tibia nail placed inside the bone to hold the fracture, with a coating aimed at infection risk (inserted either by a standard approach or through above the kneecap).
- • The control treatment: a standard titanium alloy nail placed inside the bone, without the coating.
- • X-ray checks are used to follow healing of the fracture.
Time commitment: Not stated exactly how many visits or how long the study lasts — X-ray checks continue until the fracture heals or a reoperation is needed; ask the trial team for full details.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 500
- Started
- 2022-04-11
- Last checked
- 2025-11
Plain English Summary
What is this study?
- • Testing a new treatment for tibial fractures
- • Clinical study - 500 participants
- • Primary objective of this study is to compare fracture related infection (FRI) rates of ZNN Bactiguard Tibia to conventional uncoated titanium-alloy nails 12 months after tibia fracture fixation
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with tibial fractures
Where?
- • Edinburgh - Royal Infirmary of Edinburgh
- • Leeds - Leeds General Infirmary
- • London - The Royal London Hospital
- • London - King's College Hospital NHS Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Primary objective of this study is to compare fracture related infection (FRI) rates of ZNN Bactiguard Tibia to conventional uncoated titanium-alloy nails 12 months after tibia fracture fixation. The secondary objectives are confirmation of safety, performance and clinical benefits of ZNN Bactiguard implant and related instrumentation12 months after fracture fixation.
More detail
This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study with retrospective controls. The study will enroll patients that will be implanted with the Zimmer Natural Nail Bactiguard Tibia device and retrospective controls implanted with standard titanium-alloy tibia nails. 500 tibias will be recruited at maximum 15 sites and allocated on a 1:1 ratio into an: * investigational group (prospective/consecutive series of 250 tibias treated with ZNN Bactiguard tibia) * a control group (retrospective series of 250 tibias treated with uncoated titanium-alloy tibia nail - data collection will be retrospective, these subjects will not have to undergo any study-related procedure). The primary endpoint is the Fracture Related Infection (FRI) rate in the study population 12 months after fracture fixation. The secondary endpoint is the confirmation of safety, performance and clinical benefits of ZNN Bactiguard implant and related instrumentation through the following measure systems: * Radiologic (RUST) \& clinical (FIX-IT) fracture healing 12 months after fracture fixation (performance). * Patients' outcomes assessed by the Oxford Knee Score 12 months after fracture fixation (clinical benefits). * EQ5D-5L (patients' quality of life). * Incidence and frequency of adverse events (safety). Data will be collected at 2 weeks, 3 months, 6 months and 1 year after fracture fixation.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Patient must be 18 or older.
- ✓Patient has signed IRB/EC-approved agreement to take part (if applicable for retrospective controls, based on local...
- ✓Open fractures (incl. gunshot fractures): Gustilo Type I, II, III A and III B.
- ✓Delayed treatment (initial treatment by external fixation due to swelling/ high energy trauma followed by definitive...
- ✓Fracture associated with ipsilateral leg compartment syndrome treated with fasciotomy wound(s).
Who cannot take part
- ✗Patient is unwilling or unable to give consent.
- ✗Patient is not expected to survive follow-up schedule.
- ✗Patient is anticipated to be non-compliant to the study protocol.
- ✗Patient has a mental or neurological condition or alcohol/drug addiction that will not allow for proper informed...
- ✗Patient is a prisoner.
See the full criteria
Where Is This Study? (4 UK sites)
Royal Infirmary of Edinburgh
Edinburgh EH16 4SA, United Kingdom
Leeds General Infirmary
Leeds LS1 3EX, United Kingdom
The Royal London Hospital
London E1 1FR, United Kingdom
King's College Hospital NHS Trust
London SE5 9RS, United Kingdom
How to Get in Touch
Gemma de Ramon Francas
Sponsor contactCONTACT
Lisa To
Sponsor contactCONTACT