Femur Fracture, Osteotomy
Conditions
Keywords
Intramedullary antegrade femoral nail, Bactiguard
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.
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.
Interventions
PROCEDUREFemoral fixation with intramedullary nails
Femoral fracture fixation Femoral Osteotomy
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance of the study device | 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
| Measure | Time frame | Description |
|---|---|---|
| Safety assesment | 6 weeks and 3, 6, and 12 months after fracture fixation | Recording and analyzing incidence and frequency of adverse events. |
| Oxford Hip Score | 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. |
| EQ-5D Health Questionnaire | 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. |
| Rate of fracture-related infections | 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. |
Countries
Spain, United Kingdom
Contacts
Primary ContactGemma de Ramon Francàs
Backup ContactLisa To
Outcome results
None listed