ZNN Bactiguard Cephalomedullary Nails PMCF Study

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.

Study Overview

• Status: Completed
• Conditions: Femoral Shaft Fracture; Osteotomy; Trochanteric Fractures; Sub-trochanteric Fractures
• Intervention / Treatment: Procedure: Fracture fixation via Intramedullary Nailing

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 Type: Observational
• Enrollment (Actual): 149

Contacts and Locations

Study Locations

• France
  • France
    • Douai, France, France, 59507
      • Centre Hospitalier de Douai
• Spain
  • Castille-La Mancha
    • Valladolid, Castille-La Mancha, Spain, 47012
      • Hospital Rio Hortega
  • Valencia
    • Valencia, Valencia, Spain, 46010
      • Hospital Clinico de Valencia

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 Cephalomedullary Nail according to the approved/cleared indications.

Description

Inclusion Criteria:

• 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.

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 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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Fracture fixation via Intramedullary Nailing; Fixation of trochanteric, sub-trochanteric, and shaft fractures and osteotomies.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessment by recording and analyzing incidence and frequency of adverse events.	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 document 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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2023
• Primary Completion (Actual): December 17, 2025
• Study Completion (Actual): December 17, 2025

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Bactiguard
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures; Hip Injuries; Hip Fractures
• Other Study ID Numbers: CME2021-39T

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No