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ZNN Bactiguard Cephalomedullary Nails PMCF Study

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ClinicalTrials.gov Identifier: NCT05362864
Recruitment Status : Not yet recruiting
First Posted : May 5, 2022
Last Update Posted : July 6, 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 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.


Condition or disease Intervention/treatment
Osteotomy Trochanteric Fractures Sub-trochanteric Fractures Femoral Shaft Fracture Procedure: Fracture fixation via Intramedullary Nailing

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Cephalomedullary Nails (Implants and Instrumentation). A Multicenter, Prospective, Consecutive Series
Estimated Study Start Date : December 1, 2022
Estimated Primary Completion Date : December 1, 2025
Estimated Study Completion Date : December 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Group/Cohort Intervention/treatment
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
Fixation of trochanteric, sub-trochanteric, and shaft fractures and osteotomies.




Primary Outcome Measures :
  1. Performance of the study device by analyzing fracture/osteotomy healing at 12 months after fracture fixation. [ Time Frame: 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.


Secondary Outcome Measures :
  1. Safety assessment by recording and analyzing incidence and frequency of adverse events. [ 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 document 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

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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 Cephalomedullary Nail according to the approved/cleared indications.
Criteria

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, 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.

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, 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).

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): NCT05362864


Contacts
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Contact: Gemma de Ramon Francàs +41793771196 gemma.francas@gmail.com

Sponsors and Collaborators
Zimmer Biomet
Investigators
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Study Director: Hassan Achakri Zimmer Biomet
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT05362864    
Other Study ID Numbers: CME2021-39T
First Posted: May 5, 2022    Key Record Dates
Last Update Posted: July 6, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zimmer Biomet:
Bactiguard
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries