ZNN Bactiguard Retrograde Femoral Nails PMCF Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Femoral Fracture
• Intervention / Treatment: Device: ZNN Bactiguard Retrograde Femoral Nail

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Gemma de Ramon Francàs; Phone Number: +41 79 377 11 96; Email: gemma.deramonfrancas@zimmerbiomet.com
• Study Contact Backup: Name: Emilie Rohmer; Phone Number: +41 79 368 91 28; Email: emilie.rohmer@zimmerbiomet.com

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 18-year-old patients or older with femur fractures implanted with a ZNN Bactiguard Retrograde Femoral Nail according to the approved/cleared indications.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ZNN Bactiguard Retrograde Femoral Nail; Patients implanted with a ZNN Bactiguard Retrograde Femoral Nail for fixing and stabilizing a femoral fracture.	Device: ZNN Bactiguard Retrograde Femoral Nail; Femoral fracture internal fixation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3, 6, and 12 months after fracture fixation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Femur fracture; Infection control; Intramedullary nailing; Bactiguard
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures
• Other Study ID Numbers: CME2021-40T

Drug and device information, study documents

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