ZNN Bactiguard Antegrade Femoral Nails PMCF Study

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.

Study Overview

• Status: Recruiting
• Conditions: Femur Fracture; Osteotomy
• Intervention / Treatment: Procedure: Femoral fixation with intramedullary nails

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Lisa To; Phone Number: +32 479 97 05 43; Email: lisa.to@zimmerbiomet.com
• Study Contact Backup: Name: Gemma de Ramon Francàs; Phone Number: +41 79 377 11 96; Email: gemma.deramonfrancas@zimmerbiomet.com

Study Locations

• Spain
  • Santa Cruz de Tenerife
    • Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain, 38010
      • Active, not recruiting
      • Hospital Universitario Nuestra Señora de Candelaria
• United Kingdom
  • Manchester
    • Manchester, Manchester, United Kingdom, M13 9WL
      • Recruiting
      • Manchester Royal Infirmary
      • Principal Investigator: Joseph Alsousou, Mr
      • Contact: Abigail Lamas, CTA; Phone Number: 0161 291 4850; Email: Abigail.Lomas@mft.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Femoral fixation with intramedullary nails; Femoral fracture fixation Femoral Osteotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months after fracture fixation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 weeks and 3, 6, and 12 months after fracture fixation
Safety assesment	Recording and analyzing incidence and frequency of adverse events.	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.	3, 6, and 12 months after fracture fixation

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Emilie Rohmer, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 20, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Estimated): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Bactiguard; Intramedullary antegrade femoral nail
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures; Therapeutics; Surgical Procedures, Operative; Orthopedic Procedures; Fracture Fixation; Fracture Fixation, Internal; Fracture Fixation, Intramedullary
• Other Study ID Numbers: CME2021-38T

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No