Femur FractureNCT05339360
ZNN Bactiguard Antegrade Femoral Nails PMCF Study
An observational study of Femur Fracture and Osteotomy, run by Zimmer Biomet at 2 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femur Fracture, Osteotomy
- What is being tested?
- Femoral fixation with intramedullary nails
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 Jan 2024to 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 patients aged 18 or older with femur fractures or osteotomies implanted with the ZNN Bactiguard Antegrade Femoral Nail according to the approved/cleared indications.
Who may be able to join
- Patient must be 18 or older
- Patient must have a signed EC-approved informed consent.
- Patient must have a femoral fracture (open, closed, monolateral, or bilateral) requiring surgical intervention or osteotomy 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 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 join
- 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
- Insufficient blood circulation
Show all 11Show fewer
- Infection
- Patient is unwilling to give consent.
- Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, subjects with 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 the course of study)
- Patients not expected to survive the duration of the follow-up program
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Spain1 site
- Active, not recruiting
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38010
United Kingdom1 site, 1 recruiting
- Recruiting
Manchester Royal Infirmary
Manchester, Manchester, M13 9WL
Abigail Lamas, CTA, 0161 291 4850, Abigail.Lomas@mft.nhs.uk
Joseph Alsousou, Mr
About this study
Official title: Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Antegrade Femoral Nails (Implants and Instrumentation). A Multicenter, Prospective, Consecutive Series
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.
Read the detailed description
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.
- Conditions
- Femur Fracture, Osteotomy
- Being tested
- Femoral fixation with intramedullary nails
- Keywords
- Intramedullary antegrade femoral nail, Bactiguard
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral fixation with intramedullary nailsProcedure or surgery
Femoral fracture fixation Femoral Osteotomy
| Study group | Role | What they receive |
|---|---|---|
| ZNN Bactiguard Antegrade Femoral Nail | Subjects that have received or will receive the ZNN Bacitugard Antegrade Femoral Nail to treat femoral fractures or osteotomies according to the cleared/approved indications. Receives: Procedure: Femoral fixation with intramedullary nails |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the study device
Analyzed as fracture healing 12 months after fracture fixation. Fracture healing will be analyzed radiographically and clinically. Radiographic healing is considered achieved when two or more cortices reach a score of two (2) on a version of the Radiographic Union-Scale in Tibial fractures (RUST) tool adapted for the femur, in A/P and lateral views. Clinical fracture healing will be assessed via the FiX-IT score.
Measured: 12 months after fracture fixation
Secondary outcomes (4)
Safety assesment
Recording and analyzing incidence and frequency of adverse events.
Measured: 6 weeks and 3, 6, and 12 months after fracture fixation
Oxford Hip Score
Patient-Reported Outcome Measures (PROMs) that documents hip function and pain. It's used as a surrogate to assess function and pain of the operated limb.
Measured: 3, 6, and 12 months after fracture fixation
EQ-5D Health Questionnaire
Patient-reported outcome completed by the patient. It assesses the general health status of the patient and it can be used to derive a quality of life index used for health economics considerations.
Measured: 3, 6, and 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: 6 weeks and 3, 6, and 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 posted21 Apr 2022
- Study start16 Jan 2024
- Primary completionJan 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 Femur 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
- Investigators
- Emilie Rohmer, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339360
- Sponsor's protocol ID
- CME2021-38T
- Status last verified
- Nov 2025
- First submitted
- 13 Apr 2022
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. 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 ® Antegrade Femoral Nails (Implants and Instrumentation). A Multicenter, Prospective, Consecutive Series
- ClinicalTrials.gov ID
- NCT05339360
- Acronym / sponsor ID
- CME2021-38T
- Conditions
- Femur Fracture, Osteotomy
- Keywords
- Intramedullary antegrade femoral nail, Bactiguard
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Apr 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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZNN Bactiguard Antegrade Femoral Nail | – | Procedure: Femoral fixation with intramedullary nailsSubjects that have received or will receive the ZNN Bacitugard Antegrade Femoral Nail to treat femoral fractures or osteotomies according to the cleared/approved indications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive series of patients aged 18 or older with femur fractures or osteotomies implanted with the ZNN Bactiguard Antegrade Femoral Nail according to the approved/cleared indications.
Key inclusion criteria (6 listed)
- Patient must be 18 or older
- Patient must have a signed EC-approved informed consent.
- Patient must have a femoral fracture (open, closed, monolateral, or bilateral) requiring surgical intervention or osteotomy 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 Antegrade Femoral Nail
- Patient must be able and willing to complete the protocol required for follow-up
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Femoral fixation with intramedullary nailsFemoral fracture fixation Femoral Osteotomy | Procedure or surgery | ZNN Bactiguard Antegrade Femoral Nail |
Primary outcome
Performance of the study device
Time frame: 12 months after fracture fixation
Analyzed as fracture healing 12 months after fracture fixation. Fracture healing will be analyzed radiographically and clinically. Radiographic healing is considered achieved when two or more cortices reach a score of two (2) on a version of the Radiographic Union-Scale in Tibial fractures (RUST) tool adapted for the femur, in A/P and lateral views. Clinical fracture healing will be assessed via the FiX-IT score.
4 secondary outcomes
Safety assesment
Time frame: 6 weeks and 3, 6, and 12 months after fracture fixation
Oxford Hip Score
Time frame: 3, 6, and 12 months after fracture fixation
EQ-5D Health Questionnaire
Time frame: 3, 6, and 12 months after fracture fixation
Rate of fracture-related infections
Time frame: 6 weeks and 3, 6, and 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 25 Nov 2025.
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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.
Emilie Rohmer study director
Zimmer Biomet
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femur Fracture and Osteotomy, run by Zimmer Biomet at 2 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 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain, United Kingdom. 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?
Performance of the study device (time frame: 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 25 Nov 2025; AzTrials last refreshed its copy on 7 Nov 2026.