Идёт набор NCT05276674

ZNN Bactiguard Retrograde Femoral Nails PMCF Study

— Наблюдательное Femoral Fracture

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: ZNN Bactiguard Retrograde Femoral Nail.
Кому может быть актуально: Состояния в реестре: Femoral Fracture. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Испания, Великобритания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Retrograde Femoral Nails (Implants and Instrumentation)

Обзор

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.

Подробное описание

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.

Вмешательства

Устройство ZNN Bactiguard Retrograde Femoral Nail
Femoral fracture internal fixation.

Первичные конечные точки

Rate of fracture healing 12 months after fracture fixation [Срок оценки: 3, 6, and 12 months after fracture fixation]

Вторичные конечные точки (4)

Oxford Knee Score (limb function) [Срок оценки: 3, 6, and 12 months after fracture fixation]
EQ-5D-5L score (patient's quality of life) [Срок оценки: pre-surgery (retrospectively), 3, 6, and 12 months after fracture fixation]
Adverse events frequency [Срок оценки: 12 months after fracture fixation]
Rate of fracture-related infections [Срок оценки: 12 months after fracture fixation]

Критерии участия

Критерии включения

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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет