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.
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.
Study Type
OBSERVATIONAL
Enrollment
100
Femoral fracture internal fixation.
Hospital Universitario Ntra. Sra. de Candelaria
Santa Cruz de Tenerife, Tenerife, Spain
ACTIVE_NOT_RECRUITINGLeeds General Infirmary
Leeds, LEEDS, United Kingdom
RECRUITINGManchester Royal Infirmary
Manchester, United Kingdom
RECRUITINGRate of fracture healing 12 months after fracture fixation
Fracture healing is assessed with x-ray imaging and clinical examination. Radiographic Union-Scale in Tibial fractures (RUST) score adapted for the femur, A/P and lateral views. Range: 4 - 12. Fracture healing is defined as RUST scores greater than or equal to 6. Fix-IT score (clinical examination). Range 0 - 12, higher scores indicate better limb function.
Time frame: 3, 6, and 12 months after fracture fixation
Oxford Knee Score (limb function)
Range: 0 - 48, higher scores indicate better function. Patient-reported outcome to evaluate the function of the limb treated with ZNN Bactiguard Femur Retrograde.
Time frame: 3, 6, and 12 months after fracture fixation
EQ-5D-5L score (patient's quality of life)
Range: 0 - 100, higher scores indicate better quality of life. Patient-reported outcome to evaluate quality of life.
Time frame: pre-surgery (retrospectively), 3, 6, and 12 months after fracture fixation
Adverse events frequency
The incidence and frequency of adverse events occurring during the study will be reported.
Time frame: 12 months after fracture fixation
Rate of fracture-related infections
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.
Time frame: 12 months after fracture fixation
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Stepping Hill Hospital
Stockport, United Kingdom
ACTIVE_NOT_RECRUITING