ZNN Bactiguard Retrograde Femoral Nails PMCF Study

Last updated: November 29, 2024
Sponsor: Zimmer Biomet
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

ZNN Bactiguard Retrograde Femoral Nail

Clinical Study ID

NCT05276674
CME2021-40T
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 intramedullarynailing. Patients with delayed treatment (initial treatment by external fixation dueto swelling / high energy trauma followed by definitive treatment by intramedullarynail) can also be included.

  • Patient has been or is scheduled to be treated with the ZNN Bactiguard SystemRetrograde 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 hisinstructions.

Exclusion

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 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, alcohol/drug addiction, known tobe pregnant or breast feeding).

  • Patient anticipated to be non-compliant and/or likely to have problems withmaintaining 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 Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: ZNN Bactiguard Retrograde Femoral Nail
Phase:
Study Start date:
October 23, 2023
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • Hospital Universitario Ntra. Sra. de Candelaria

    Santa Cruz De Tenerife, Tenerife 38010
    Spain

    Site Not Available

  • Leeds General Infirmary

    Leeds, LS1 3EX
    United Kingdom

    Active - Recruiting

  • Manchester Royal Infirmary

    Manchester,
    United Kingdom

    Active - Recruiting

  • Stepping Hill Hospital

    Stockport,
    United Kingdom

    Site Not Available

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