ZNN Bactiguard Retrograde Femoral Nails PMCF Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ZNN Bactiguard Retrograde Femoral Nail.
- Who it may be relevant to
- Registry conditions: Femoral Fracture. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Retrograde Femoral Nails (Implants and Instrumentation)
Overview
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.
Detailed 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.
Interventions
- Device ZNN Bactiguard Retrograde Femoral Nail
Femoral fracture internal fixation.
Primary outcome measures
- Rate of fracture healing 12 months after fracture fixation [Time frame: 3, 6, and 12 months after fracture fixation]
Secondary outcome measures (4)
- Oxford Knee Score (limb function) [Time frame: 3, 6, and 12 months after fracture fixation]
- EQ-5D-5L score (patient's quality of life) [Time frame: pre-surgery (retrospectively), 3, 6, and 12 months after fracture fixation]
- Adverse events frequency [Time frame: 12 months after fracture fixation]
- Rate of fracture-related infections [Time frame: 12 months after fracture fixation]
Eligibility criteria
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 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 Retrograde 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 his instructions.
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 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, 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 course of study).
- Not expected to survive the duration of the follow-up program
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 3 centers
- Leeds General Infirmary — Leeds
- Manchester Royal Infirmary — Manchester
- Stepping Hill Hospital — Stockport
Spain · 1 center
- Hospital Universitario Ntra. Sra. de Candelaria — Santa Cruz de Tenerife
Identifiers
NCT: NCT05276674 · CME2021-40T