OsteotomyNCT05362864
ZNN Bactiguard Cephalomedullary Nails PMCF Study
An observational study of Osteotomy and Trochanteric Fractures, run by Zimmer Biomet at 3 sites in 2 countries.
Trial summary
This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study on the ZNN Bactiguard Cephalomedullary 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteotomy, Trochanteric Fractures, Sub-trochanteric Fractures
- What is being tested?
- Fracture fixation via Intramedullary Nailing
- Type of treatment
- Surgery or procedure
- How many people
- 149 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 23 Jan 2023to 17 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Cephalomedullary Nail according to the approved/cleared indications.
Who may be able to join
- Patients 18 years or older.
- Patient must have a signed EC approved informed consent.
- Patient must have a monolateral or bilateral trochanteric, sub-trochanteric, or shaft fracture requiring surgical intervention or osteotomy and be eligible for fixation by intramedullary nailing.
- Patient has been or is scheduled to be treated with the ZNN Bactiguard System Cephalomedullary Nail.
- Patient must be able and willing to complete the protocol required 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
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- 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, subject with alcohol/drug addiction, known to be pregnant or breastfeeding).
- Patient anticipated to be non-compliant and/or likely to have problems complying with the follow-up program (e.g. patient with no fixed address, long-distance, plans to move during course of study).
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Spain2 sites
Hospital Clinico de Valencia
Valencia, Valencia, 46010
Hospital Rio Hortega
Valladolid, Castille-La Mancha, 47012
About this study
Official title: Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Cephalomedullary 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 Cephalomedullary 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 trochanteric, sub-trochanteric or shaft 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 Cephalomedullary Nails. The primary endpoint for this study is the assessment of performance by analyzing fracture/osteotomy healing within 12 months after fracture fixation. Radiological fracture healing is defined as bridging callus on at least three of the four cortices on the AP and lateral radiographs and clinically as full weight-bearing without pain.
The secondary endpoint is the assessment of safety, clinical benefit, and postop 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 Cephalomedullary Nail according to the approved/cleared indications. The sample size for this study is 150 study cases, and up to 10 sites in EMEA will participate.
- Being tested
- Fracture fixation via Intramedullary Nailing
- Keywords
- Bactiguard
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fracture fixation via Intramedullary NailingProcedure or surgery
Fixation of trochanteric, sub-trochanteric, and shaft fractures and osteotomies.
| Study group | Role | What they receive |
|---|---|---|
| ZNN Bactiguard CMN | Subjects that have received or will receive the ZNN Bacitugard Cephalomedullaryl Nail to treat trochanteric, sub-trochanteric, and shaft fractures and osteotomies according to the cleared/approved indications. Receives: Procedure: Fracture fixation via Intramedullary Nailing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the study device by analyzing fracture/osteotomy healing at 12 months after fracture fixation.
Performance will be assessed by analyzing fracture/osteotomy healing at 12 months after fracture fixation. Fracture healing will be assessed clinically and radiologically:
- Radiological fracture healing is defined as bridging callus on at least three of the four cortices on the AP. and lateral radiographs
- Clinical fracture healing is defined as full weight-bearing without pain.
Measured: 12 months after fracture fixation
Secondary outcomes (4)
Safety assessment by recording and analyzing incidence and frequency of adverse events.
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 document 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 posted5 May 2022
- Study start23 Jan 2023
- Primary completion17 Dec 2025
- Study completion17 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteotomyStudies 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
- 149 participants (actual)
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
- NCT05362864
- Sponsor's protocol ID
- CME2021-39T
- Status last verified
- Aug 2025
- First submitted
- 2 May 2022
- Last updated
- 22 May 2026
- 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 22 May 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 ® Cephalomedullary Nails (Implants and Instrumentation). A Multicenter, Prospective, Consecutive Series
- ClinicalTrials.gov ID
- NCT05362864
- Acronym / sponsor ID
- CME2021-39T
- Keywords
- Bactiguard
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 17 Dec 2025 (actual)
- First posted
- 5 May 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 Cephalomedullary 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 trochanteric, sub-trochanteric or shaft 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 Cephalomedullary Nails. The primary endpoint for this study is the assessment of performance by analyzing fracture/osteotomy healing within 12 months after fracture fixation. Radiological fracture healing is defined as bridging callus on at least three of the four cortices on the AP and lateral radiographs and clinically as full weight-bearing without pain.
The secondary endpoint is the assessment of safety, clinical benefit, and postop 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 Cephalomedullary Nail according to the approved/cleared indications. The sample size for this study is 150 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 CMN | – | Procedure: Fracture fixation via Intramedullary NailingSubjects that have received or will receive the ZNN Bacitugard Cephalomedullaryl Nail to treat trochanteric, sub-trochanteric, and shaft fractures and 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 Cephalomedullary Nail according to the approved/cleared indications.
Key inclusion criteria (6 listed)
- Patients 18 years or older.
- Patient must have a signed EC approved informed consent.
- Patient must have a monolateral or bilateral trochanteric, sub-trochanteric, or shaft fracture requiring surgical intervention or osteotomy and be eligible for fixation by intramedullary nailing.
- Patient has been or is scheduled to be treated with the ZNN Bactiguard System Cephalomedullary Nail.
- Patient must be able and willing to complete the protocol required follow-up.
Key exclusion criteria (10 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 |
|---|---|---|
| Fracture fixation via Intramedullary NailingFixation of trochanteric, sub-trochanteric, and shaft fractures and osteotomies. | Procedure or surgery | ZNN Bactiguard CMN |
Primary outcome
Performance of the study device by analyzing fracture/osteotomy healing at 12 months after fracture fixation.
Time frame: 12 months after fracture fixation
Performance will be assessed by analyzing fracture/osteotomy healing at 12 months after fracture fixation. Fracture healing will be assessed clinically and radiologically: * Radiological fracture healing is defined as bridging callus on at least three of the four cortices on the AP. and lateral radiographs * Clinical fracture healing is defined as full weight-bearing without pain.
4 secondary outcomes
Safety assessment by recording and analyzing incidence and frequency of adverse events.
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 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. This study is not recruiting at the moment.
Emilie Rohmer study director
Zimmer Biomet
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteotomy and Trochanteric Fractures, run by Zimmer Biomet at 3 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 10 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: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain, France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the study device by analyzing fracture/osteotomy healing at 12 months after fracture fixation. (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 22 May 2026.