Идёт набор NCT05339360

ZNN Bactiguard Antegrade Femoral Nails PMCF Study

— Наблюдательное Femur Fracture Osteotomy

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: Femoral fixation with intramedullary nails.
Кому может быть актуально: Состояния в реестре: Femur Fracture, Osteotomy. 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 ® Antegrade Femoral Nails (Implants and Instrumentation). A Multicenter, Prospective, Consecutive Series

Обзор

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.

Подробное описание

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.

Вмешательства

Процедура Femoral fixation with intramedullary nails
Femoral fracture fixation Femoral Osteotomy

Первичные конечные точки

Performance of the study device [Срок оценки: 12 months after fracture fixation]

Вторичные конечные точки (4)

Safety assesment [Срок оценки: 6 weeks and 3, 6, and 12 months after fracture fixation]
Oxford Hip Score [Срок оценки: 3, 6, and 12 months after fracture fixation]
EQ-5D Health Questionnaire [Срок оценки: 3, 6, and 12 months after fracture fixation]
Rate of fracture-related infections [Срок оценки: 6 weeks and 3, 6, and 12 months after fracture fixation]

Критерии участия

Критерии включения

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

Критерии исключения

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

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

Здоровые добровольцы: Нет