ZNN Bactiguard Antegrade Femoral Nails PMCF Study

NCT05339360 | Recruiting

• 1 other identifier: CME2021-38T
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 2

Brief 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 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.

Conditions

Femur Fracture; Osteotomy

Keywords

Intramedullary antegrade femoral nail; Bactiguard

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Safety assesment

  6 weeks and 3, 6, and 12 months after fracture fixation

• Oxford Hip Score

  3, 6, and 12 months after fracture fixation

• EQ-5D Health Questionnaire

  3, 6, and 12 months after fracture fixation

• Rate of fracture-related infections

  6 weeks and 3, 6, and 12 months after fracture fixation

Study Arms (1)

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

Interventions

Femoral fixation with intramedullary nails PROCEDURE

Femoral fracture fixation Femoral Osteotomy

ZNN Bactiguard Antegrade Femoral Nail

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (2)

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38010, Spain

ACTIVE NOT RECRUITING

Manchester Royal Infirmary

Manchester, Manchester, M13 9WL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Femoral Fractures

Interventions

Fracture Fixation, Intramedullary

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation, Internal; Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Emilie Rohmer

  Zimmer Biomet

  STUDY DIRECTOR

Central Study Contacts

Gemma de Ramon Francàs

CONTACT

+41 79 377 11 96; gemma.deramonfrancas@zimmerbiomet.com

Lisa To

CONTACT

+32 479 97 05 43; lisa.to@zimmerbiomet.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 21, 2022
• Study Start: January 16, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

ES (1); GB (1)