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 Retrograde Femoral Nail (device)
- How long the study runs
- Study runs about 50 months (dates as stated)
- About the drug or intervention
- ZNN Bactiguard Retrograde Femoral Nail — device: Femoral fracture internal fixation.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at the ZNN Bactiguard Retrograde Femoral Nail, a metal rod used to fix a broken thigh bone (femur). It is a follow-up study after the product is already in use, run by the sponsor Zimmer Biomet, to collect information about patients treated with this nail. The condition being studied is a femoral fracture.
Who can take part
- Adults aged 18 or over
- Have a broken thigh bone (femur) that needs surgery and can be treated with a metal rod inside the bone (intramedullary nail), including cases where treatment was delayed because of swelling or severe injury
- Have had or are due to have the ZNN Bactiguard Retrograde Femoral Nail
- Able and willing to attend the study follow-up appointments
- Have given signed consent approved by an ethics committee
- Able to understand the surgeon's explanations and follow their instructions
Who may not be able to
- Younger people whose bones are still growing
- The space inside the bone is blocked by an earlier fracture or tumour
- The thigh bone is very curved or misshapen
- Not enough bone strength or substance for the implant to sit firmly
- Other health conditions that could harm the operation, how the implant works, or its success
- Poor blood circulation
- Infection
- Not willing or not able to give consent
- People in vulnerable situations, such as prisoners, those unable to understand the study, people with alcohol or drug problems, or those who are pregnant or breastfeeding
- People unlikely to keep to the follow-up plan, for example 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 broken thigh bone using the ZNN Bactiguard Retrograde Femoral Nail
- • Follow-up checks as required by the study plan
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team about how many visits there will be, how long the study lasts, and exactly what taking part involves.
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
- 2023-10-23
- Last checked
- 2026-01
Plain English Summary
What is this study?
- • Testing a new treatment for femoral fracture
- • Clinical study - 100 participants
- • Post-market clinical follow-up (PMCF) study to confirm the safety, performance, and clinical benefits of the intra-medullary retrograde femoral nail Zimmer Natural Nail (ZNN) Bactiguard (implants and instrumentation) when used for the temporary internal fixation and stabilization of femoral fractures
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with femoral fracture
Where?
- • Leeds - Leeds General Infirmary
- • Manchester - Manchester Royal Infirmary
- • Stockport - Stepping Hill Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Post-market clinical follow-up (PMCF) study to confirm the safety, performance, and clinical benefits of the intra-medullary retrograde femoral nail Zimmer Natural Nail (ZNN) Bactiguard (implants and instrumentation) when used for the temporary internal fixation and stabilization of femoral fractures.
More detail
The objective of this prospective PMCF study is to collect data to confirm safety, performance and clinical benefits of the Zimmer Natural Nail (ZNN) Bactiguard Retrograde Femoral Nail (implants and instrumentation) when used for the temporary internal fixation and stabilization of femoral fractures. The primary endpoint is the assessment of performance by analyzing fracture healing. The secondary endpoints are 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.
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:
- ✓ follow-up
- ✓ a signed EC approved consent
What the study is looking for
- ✓Patients must be 18 years or older.
- ✓Patient has been or is scheduled to be treated with the ZNN Bactiguard System Retrograde Femoral Nail.
- ✓Patient must be able and willing to complete the protocol required follow-up.
- ✓Patient must have a signed EC approved consent.
- ✓Patients capable of understanding the surgeon's explanations and following his instructions.
Who cannot take part
- ✗Skeletally immature patients
- ✗A 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? (3 UK sites)
Leeds General Infirmary
Leeds LS1 3EX, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom
Stepping Hill Hospital
Stockport, United Kingdom
Research, Development & Innovation Office
research.development@stockport.nhs.uk0161 419 5893How to Get in Touch
Gemma de Ramon Francàs
Sponsor contactCONTACT
Emilie Rohmer
Sponsor contactCONTACT
