ZNN Bactiguard Cephalomedullary Nails PMCF Study

NCT05362864 | Active Not Recruiting

• 1 other identifier: CME2021-39T
• Study Type: observational
• Target: 150
• Locations: 2 countries
• Sites: 3

Brief 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 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.

Conditions

Osteotomy; Trochanteric Fractures; Sub-trochanteric Fractures; Femoral Shaft Fracture

Keywords

Bactiguard

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Safety assessment by recording and analyzing incidence and frequency of adverse events.

  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 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

Interventions

Fracture fixation via Intramedullary Nailing PROCEDURE

Fixation of trochanteric, sub-trochanteric, and shaft fractures and osteotomies.

ZNN Bactiguard CMN

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 Cephalomedullary Nail according to the approved/cleared indications.

You may qualify if:

• 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.

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 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).

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (3)

Centre Hospitalier de Douai

Douai, France, 59507, France

Location

Hospital Rio Hortega

Valladolid, Castille-La Mancha, 47012, Spain

Location

Hospital Clinico de Valencia

Valencia, Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Emilie Rohmer

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 5, 2022
• Study Start: January 23, 2023
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); ES (2)