ZNN Bactiguard Cephalomedullary Nails PMCF Study

Last updated: July 4, 2024
Sponsor: Zimmer Biomet
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoporosis

Treatment

Fracture fixation via Intramedullary Nailing

Clinical Study ID

NCT05362864
CME2021-39T
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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, orshaft fracture requiring surgical intervention or osteotomy and be eligible forfixation by intramedullary nailing.

  • Patient has been or is scheduled to be treated with the ZNN Bactiguard SystemCephalomedullary Nail.

  • Patient must be able and willing to complete the protocol required follow-up.

  • Patients capable of understanding the surgeon's explanations and following hisinstructions.

Exclusion

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 implantimpossible

  • All concomitant diseases that can impair the operation, functioning or the successof the implant

  • Insufficient blood circulation

  • Infection

  • Patient is unwilling or unable to give consent.

  • Patient is a vulnerable subject (prisoner, mentally incompetent or unable tounderstand what participation to the study entails, subject with alcohol/drugaddiction, known to be pregnant or breastfeeding).

  • Patient anticipated to be non-compliant and/or likely to have problems complyingwith the follow-up program (e.g. patient with no fixed address, long-distance, plansto move during course of study).

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Fracture fixation via Intramedullary Nailing
Phase:
Study Start date:
January 23, 2023
Estimated Completion Date:
January 01, 2026

Study 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.

Connect with a study center

  • Centre Hospitalier de Douai

    Douai, 59507
    France

    Site Not Available

  • Hospital Rio Hortega

    Valladolid, Castilla-La Mancha 47012
    Spain

    Active - Recruiting

  • Hospital Clinico de Valencia

    Valencia, 46010
    Spain

    Active - Recruiting

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