We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

ZNN Bactiguard Antegrade Femoral Nails PMCF Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05339360
Recruitment Status : Not yet recruiting
First Posted : April 21, 2022
Last Update Posted : July 22, 2022
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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.


Condition or disease Intervention/treatment
Femur Fracture Osteotomy Procedure: Femoral fixation with intramedullary nails

Detailed Description:

This study is a multicentre, prospective, post-market clinical follow-up study on the Zimmer Natural Nail (ZNN) Bactiguard Antegrade Femoral Nails.

The primary endpoint for this study is the assessment of performance by analyzing fracture healing within 12 months after fracture fixation. Fracture healing will be analyzed radiologically by the RUSH score adapted to the femur and clinically by the Fix-IT score.

The secondary endpoint is 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.

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 Antegrade Femoral Nail according to the approved/cleared indications. The sample size for this study is 100 study cases, and up to 10 sites in EMEA will participate.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Antegrade Femoral Nails (Implants and Instrumentation). A Multicenter, Prospective, Consecutive Series
Estimated Study Start Date : December 2022
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Femoral fracture fixation Femoral Osteotomy




Primary Outcome Measures :
  1. Performance of the study device [ Time Frame: 12 months after fracture fixation ]
    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.


Secondary Outcome Measures :
  1. Safety assesment [ Time Frame: 6 weeks and 3, 6, and 12 months after fracture fixation ]
    Recording and analyzing incidence and frequency of adverse events.

  2. Oxford Hip Score [ Time Frame: 3, 6, and 12 months after fracture fixation ]
    Patient-Reported Outcome Measures (PROMs) that documents hip function and pain. It's used as a surrogate to assess function and pain of the operated limb.

  3. EQ-5D Health Questionnaire [ Time Frame: 3, 6, and 12 months after fracture fixation ]
    Patient-reported outcome completed by the patient. It assesses the general health status of the patient and it can be used to derive a quality of life index used for health economics considerations.

  4. Rate of fracture-related infections [ Time Frame: 6 weeks and 3, 6, and 12 months after fracture fixation ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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

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 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, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05339360


Contacts
Layout table for location contacts
Contact: Gemma de Ramon Francàs +41 79 377 11 96 gemma.deramonfrancas@zimmerbiomet.com
Contact: Gregoire Masliah +41 79 625 54 68 gregoire.masliah@zimmerbiomet.com

Locations
Layout table for location information
Italy
AOU Sant'Andrea
Rom, Roma, Italy, 00189
Contact: Antonio Vadala    333.2965643    anto.vada76@gmail.com   
Sponsors and Collaborators
Zimmer Biomet
Investigators
Layout table for investigator information
Study Director: Hassan Achakri Zimmer Biomet
Layout table for additonal information
Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT05339360    
Other Study ID Numbers: CME2021-38T
First Posted: April 21, 2022    Key Record Dates
Last Update Posted: July 22, 2022
Last Verified: July 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zimmer Biomet:
Intramedullary antegrade femoral nail
Bactiguard
Additional relevant MeSH terms:
Layout table for MeSH terms
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Leg Injuries