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
- Femoral fixation with intramedullary nails (procedure)
- How long the study runs
- Study runs about 47 months (dates as stated)
- About the drug or intervention
- Femoral fixation with intramedullary nails — procedure: Femoral fracture fixation Femoral Osteotomy
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by Zimmer Biomet, is looking at the ZNN Bactiguard Antegrade Femoral Nail, a metal rod used to fix a broken thigh bone (femur) or a bone that has been surgically cut (osteotomy). It is a post-market clinical follow-up (PMCF) study, which means the device is already in use and this study collects information about how it works in patients.
Who can take part
- Adults aged 18 or older
- Patients who have given informed consent (agreed in writing to take part)
- People with a thigh bone (femur) fracture needing surgery, or an osteotomy, that can be treated with a rod placed inside the bone
- People treated first with an external frame because of swelling or severe injury, who later have the rod put in, can also join
- People already treated with, or due to receive, the ZNN Bactiguard Antegrade Femoral Nail
- People able and willing to attend follow-up appointments
- People able to understand the surgeon's explanations and follow their instructions
Who may not be able to
- People whose bones are still growing
- People whose bone marrow canal is blocked by an earlier fracture or tumour
- People whose thigh bone is overly bent or deformed
- People whose bone strength or amount of bone makes it impossible to hold the implant firmly
- People with other illnesses that could harm the operation, how the implant works, or its success
- People with poor blood circulation
- People with an infection
- People who do not want to give consent
- People considered vulnerable, for example prisoners, people unable to understand the study, people with alcohol or drug addiction, and people who are pregnant or breastfeeding
- People unlikely to attend follow-up, for example those with no fixed address or planning to move away
- People not expected to live through the follow-up period
What taking part involves
- • Surgery to fix the thigh bone using the ZNN Bactiguard Antegrade Femoral Nail
- • Attending follow-up appointments and completing the study follow-up plan as required by the study protocol — further details not stated; ask the trial team
Time commitment: Taking part involves surgery with the study nail and attending follow-up visits as set out in the study plan — the number of visits and total duration are not stated; ask the trial team.
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
- 100
- Started
- 2024-01-16
- Last checked
- 2025-11
Plain English Summary
What is this study?
- • Testing a new treatment for femur fracture
- • Clinical study - 100 participants
- • This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study on the ZNN Bactiguard Antegrade Femoral Nails
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with femur fracture
Where?
- • Manchester - Manchester Royal Infirmary
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study on the ZNN Bactiguard Antegrade Femoral Nails. The objective of this study is to collect data confirming the safety, performance, and clinical benefit of the study device and instrumentation when used for the temporary internal fixation and stabilization of femoral fractures and osteotomies. This is a CE-marked device already available on the market and the aim of the study is to comply with the post-market surveillance requirements.
More detail
This study is a multicentre, prospective, post-market clinical follow-up study on the Zimmer Natural Nail (ZNN) Bactiguard Antegrade Femoral Nails. The primary endpoint for this study is the assessment of performance by analyzing fracture healing within 12 months after fracture fixation. Fracture healing will be analyzed radiologically by the RUSH score adapted to the femur and clinically by the Fix-IT score. The secondary endpoint is the assessment of safety, clinical benefit, and post-op fracture-related infection (FRI). Safety will be evaluated by recording and analyzing the incidence and frequency of complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. Clinical benefit will be assessed by recording patient-reported outcome measures (PROMs). FRIs will be classified according to the updated diagnostic algorithm defined by the FRI Consensus Group. Data will be collected at 6 weeks, 3 months, 6 months and 1 year after fracture fixation. The study will enroll patients implanted with the Zimmer Natural Nail Bactiguard Antegrade Femoral Nail according to the approved/cleared indications. The sample size for this study is 100 study cases, and up to 10 sites in EMEA will participate.
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
Treatment history
Treatments you must have had:
- ✓ a signed EC-approved informed consent
- ✓ for follow-up
What the study is looking for
- ✓Patient must be 18 or older
- ✓Patient must have a signed EC-approved agreement to take part.
- ✓Patient has been or is scheduled to be treated with the ZNN Bactiguard System Antegrade Femoral Nail
- ✓Patient must be able and willing to complete the protocol required for follow-up
- ✓Patients capable of understanding the surgeon's explanations and following his instructions
Who cannot take part
- ✗Skeletally immature patients
- ✗Medullary canal obliterated by a previous fracture or tumor
- ✗Bone shaft having excessive bow or a deformity
- ✗Lack of bone substance or bone quality, which makes stable seating of the implant impossible
- ✗All concomitant diseases that can impair the operation, functioning or the success of the implant
See the full criteria
Where Is This Study? (1 UK site)
Manchester Royal Infirmary
Manchester M13 9WL, United Kingdom
How to Get in Touch
Gemma de Ramon Francàs
Sponsor contactCONTACT
Lisa To
Sponsor contactCONTACT