Femoral FractureNCT05276674
ZNN Bactiguard Retrograde Femoral Nails PMCF Study
An observational study of Femoral Fracture, run by Zimmer Biomet at 4 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral Fracture
- What is being tested?
- ZNN Bactiguard Retrograde Femoral Nail
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 23 Oct 2023to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive series of 18-year-old patients or older with femur fractures implanted with a ZNN Bactiguard Retrograde Femoral Nail according to the approved/cleared indications.
Who may be able to join
- Patients must be 18 years or older.
- Patient must have a femoral fracture (open, closed, monolateral or bilateral) requiring surgical intervention and be eligible for fixation by intramedullary nailing. Patients with delayed treatment (initial treatment by external fixation due to swelling / high energy trauma followed by definitive treatment by intramedullary nail) can also be included.
- 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 join
- 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
- Insufficient blood circulation
Show all 11Show fewer
- Infection
- Patient is unwilling or unable to give consent.
- Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, alcohol/drug addiction, known to be pregnant or breast feeding).
- Patient anticipated to be non-compliant and/or likely to have problems with maintaining follow-up program (e.g. patient with no fixed address, long distance, plans to move during course of study).
- Not expected to survive the duration of the follow-up program
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United Kingdom3 sites, 2 recruiting
- Recruiting
Leeds General Infirmary
Leeds, LEEDS, LS1 3EX
Fiazia Ahmed, 0113 34 30096, F.S.Ahmed@leeds.ac.uk
Nikolaos K Kanakaris, Dr
- Recruiting
Manchester Royal Infirmary
Manchester
Abigail Lamas, abigail.lomas@mft.nhs.uk
Joseph Alsousou
- Active, not recruiting
Stepping Hill Hospital
Stockport
Spain1 site
- Active, not recruiting
Hospital Universitario Ntra. Sra. de Candelaria
Santa Cruz de Tenerife, Tenerife, 38010
About this study
Official title: Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Retrograde Femoral Nails (Implants and Instrumentation)
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.
Read the detailed description
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.
- Conditions
- Femoral Fracture
- Being tested
- ZNN Bactiguard Retrograde Femoral Nail
- Keywords
- Bactiguard, Femur fracture, Intramedullary nailing, Infection control
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZNN Bactiguard Retrograde Femoral NailDevice
Femoral fracture internal fixation.
| Study group | Role | What they receive |
|---|---|---|
| ZNN Bactiguard Retrograde Femoral Nail | Patients implanted with a ZNN Bactiguard Retrograde Femoral Nail for fixing and stabilizing a femoral fracture. Receives: Device: ZNN Bactiguard Retrograde Femoral Nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of fracture healing 12 months after fracture fixation
Fracture healing is assessed with x-ray imaging and clinical examination.
Radiographic Union-Scale in Tibial fractures (RUST) score adapted for the femur, A/P and lateral views. Range: 4 - 12. Fracture healing is defined as RUST scores greater than or equal to 6.
Fix-IT score (clinical examination). Range 0 - 12, higher scores indicate better limb function.
Measured: 3, 6, and 12 months after fracture fixation
Secondary outcomes (4)
Oxford Knee Score (limb function)
Range: 0 - 48, higher scores indicate better function. Patient-reported outcome to evaluate the function of the limb treated with ZNN Bactiguard Femur Retrograde.
Measured: 3, 6, and 12 months after fracture fixation
EQ-5D-5L score (patient's quality of life)
Range: 0 - 100, higher scores indicate better quality of life. Patient-reported outcome to evaluate quality of life.
Measured: pre-surgery (retrospectively), 3, 6, and 12 months after fracture fixation
Adverse events frequency
The incidence and frequency of adverse events occurring during the study will be reported.
Measured: 12 months after fracture fixation
Rate of fracture-related infections
Fracture-related infections are diagnosed in accordance with the algorithm described in M McNally,G Govaert, M Dudareva, M Morgenstern, W J Metsemakers, EFORT Open Rev 2020;5:614-619.
Measured: 12 months after fracture fixation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start23 Oct 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral FractureStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276674
- Sponsor's protocol ID
- CME2021-40T
- Status last verified
- Jan 2026
- First submitted
- 2 Mar 2022
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Retrograde Femoral Nails (Implants and Instrumentation)
- ClinicalTrials.gov ID
- NCT05276674
- Acronym / sponsor ID
- CME2021-40T
- Conditions
- Femoral Fracture
- Keywords
- Bactiguard, Femur fracture, Intramedullary nailing, Infection control
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZNN Bactiguard Retrograde Femoral Nail | – | Device: ZNN Bactiguard Retrograde Femoral NailPatients implanted with a ZNN Bactiguard Retrograde Femoral Nail for fixing and stabilizing a femoral fracture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive series of 18-year-old patients or older with femur fractures implanted with a ZNN Bactiguard Retrograde Femoral Nail according to the approved/cleared indications.
Key inclusion criteria (6 listed)
- Patients must be 18 years or older.
- Patient must have a femoral fracture (open, closed, monolateral or bilateral) requiring surgical intervention and be eligible for fixation by intramedullary nailing. Patients with delayed treatment (initial treatment by external fixation due to swelling / high energy trauma followed by definitive treatment by intramedullary nail) can also be included.
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZNN Bactiguard Retrograde Femoral NailFemoral fracture internal fixation. | Device | ZNN Bactiguard Retrograde Femoral Nail |
Primary outcome
Rate of fracture healing 12 months after fracture fixation
Time frame: 3, 6, and 12 months after fracture fixation
Fracture healing is assessed with x-ray imaging and clinical examination. Radiographic Union-Scale in Tibial fractures (RUST) score adapted for the femur, A/P and lateral views. Range: 4 - 12. Fracture healing is defined as RUST scores greater than or equal to 6. Fix-IT score (clinical examination). Range 0 - 12, higher scores indicate better limb function.
4 secondary outcomes
Oxford Knee Score (limb function)
Time frame: 3, 6, and 12 months after fracture fixation
EQ-5D-5L score (patient's quality of life)
Time frame: pre-surgery (retrospectively), 3, 6, and 12 months after fracture fixation
Adverse events frequency
Time frame: 12 months after fracture fixation
Rate of fracture-related infections
Time frame: 12 months after fracture fixation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Fracture, run by Zimmer Biomet at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gemma de Ramon Francàs (+41 79 377 11 96, gemma.deramonfrancas@zimmerbiomet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of fracture healing 12 months after fracture fixation (time frame: 3, 6, and 12 months after fracture fixation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.