Идёт набор NCT06354543

Arthroplasty Cements Outcomes - A Post-market Follow-up

— Наблюдательное Arthroplasty

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: Cemented joint arthroplasty.
Кому может быть актуально: Состояния в реестре: Arthroplasty. 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: Франция, Италия
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

Safety and Clinical Performance Assessment of Bone Cements and Cement Restrictor Used in Arthroplasty - A Post-market Clinical Follow-up

Обзор

A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all Teknimed Arthroplasty range of products: CEMFIX® and GENTAFIX® bone cements families and CEMSTOP® cement restrictor, and all their private labels. Teknimed bone cements and cement restrictor are legacy products, some marketed for more than 20 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a "real-life" setting. The study is a retrospective and prospective global, single arm, non-controlled, multicentric, ambispective observational study. Patients will be followed as per local standard medical care of the site.

Подробное описание

It is admitted that:

* Joint replacement is a commonly performed major surgical procedure that has considerable success in alleviating pain and disability; * These procedures may be done with the help of a bone cement (PMMA) to fix the prosthesis to the bone (cemented fixation); * Most common reasons for primary joint replacement are osteoarthritis, osteonecrosis and trauma; * Most common reasons for revision of joint replacement are dislocation, infection, fracture and prothesis loosening; * Quality of bone cement have a large influence on long-term implant stability.

TEKNIMED has developed several bone cements and a cement restrictor currently used in arthroplasty procedures.

With the increasing use of these procedures, there is a need of real-life long-term safety and efficacy data on the bone cements.

This retro- and prospective study is performed to assess the safety and performance of TEKNIMED arthroplasty products in their current clinical use.

Вмешательства

Устройство Cemented joint arthroplasty
Joint replacement with cemented prosthetic components

Первичные конечные точки

Survival rate [Срок оценки: 15 years (until the lifetime of the device)]
Superficial and/or deep postoperative infection rate. [Срок оценки: 15 years (until the lifetime of the device)]

Вторичные конечные точки (9)

Pain Level [Срок оценки: 5 years]
Patients' satisfaction [Срок оценки: 5 years]
Restoration of function [Срок оценки: 5 years]
Evaluation of function and radiological outcomes [Срок оценки: 5 years]
Complications rate [Срок оценки: 5 years]
Antalgic consumption [Срок оценки: 5 years]
Restoration of function [Срок оценки: 5 years]
Restoration of function [Срок оценки: 5 years]
Adverse events [Срок оценки: 15 years (until the lifetime of the device)]

Критерии участия

Критерии включения

Be 18 years or older.
Be willing to sign an informed consent approved by Institutional Review Board (IRB) or European Commission (EC) (when applicable) or not oppose to the use of their clinical data in the study
For prospective inclusion: be considered for an arthroplasty procedure with one of the TEKNIMED orthopaedic cement and/or cement restrictor comprised in this study (primary or revision surgery).
For retrospective inclusion: have undergone a primary or revision arthroplasty procedure with a TEKNIMED orthopaedic cement and/or cement restrictor between the 1st January 2016 and the date of the site initiation visit (SIV).
Be informed of the study and not being opposed to the use of their clinical data in the study or be willing to sign an informed consent during the first follow-up visit following the site initiation (where applicable).

Критерии исключения

Patient under trusteeship or guardianship,
Women who are pregnant
Patient unable to follow the protocol
Patient whose vital prognosis is unfavorable (according to investigator's opinion)

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

Здоровые добровольцы: Нет