Набор по приглашению NCT07370493

Retrospective Analysis of Patients Implanted With 2 Levels of Prodisc® C Vivo Devices

— Наблюдательное Degenerative Disc Disease Cervical Spine Degenerative Disease Symptomatic Cervical Disc Disease Cervical Spine Degenerative Disc Disease

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: Prodisc C Vivo.
Кому может быть актуально: Состояния в реестре: Degenerative Disc Disease, Cervical Spine Degenerative Disease, Symptomatic Cervical Disc Disease, Cervical Spine Degenerative Disc Disease. Базовые параметры: Без ограничений · 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: Германия
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

A Multicenter, Retrospective Analysis to Evaluate Radiographic Outcomes and Safety Profiles Along Prospective Follow-Up Periods for Patients Implanted With 2 Levels of Prodisc® C Vivo Devices.

Обзор

The objective of the study is to evaluate the safety and post-operative performance profile of the prodisc® C Vivo after implantation in comparison to the relevant clinical literature.

Подробное описание

The primary objective of the study is to evaluate (estimate) the post-operative performance of prodisc® C Vivo overall, after implantation. Post-operative device performance will be estimated using Patient Reported Outcomes (PROs) and radiographic data derived from the patient's surgical charts and medical history.

The secondary objectives of this study are to assess:

* patients with no secondary surgical interventions (SSIs), i.e. revision, removal, re-operation, supplemental fixation at the index level(s) * the rates of ADEs inclusive of intraoperative and post-operative complications * Patient Reported Outcomes (PROs) * Outcome self-assessment of Health Survey (SF 12 or 36 as available)

Вмешательства

Устройство Prodisc C Vivo
The prodisc® C Vivo device is a non-keeled cervical disc replacement prosthesis. The device is modular intervertebral disc prostheses designed to replace a diseased and/or a degenerated disc of the cervical spine in SCDD patients, thereby restoring disc height, biomechanical stability and allowing the potential for motion at the affected vertebral segment.

Первичные конечные точки

Evaluation of the Occurrence of Secondary Surgical Interventions in Patients Treated with prodisc® C Vivo at 2 Levels [Срок оценки: 10 year post-operative screening of prodisc C Vivo patients implanted from JAN 2010 to present]

Вторичные конечные точки (1)

Assessment to demonstrate the continuous clinical and radiographic status of the prodisc C Vivo implants allowing characterization of performance of the device by nominal variables (percentages) based on ADEs, SSIs, PROs, and SF 12 data collection [Срок оценки: 10 Year Post-operative 10 year post-operative screening of prodisc C Vivo patients implanted from JAN 2010 to present]

Критерии участия

Критерии включения

In order for a patient's data to be included in this study, he/she has to meet the indications and not possess any of the specific or general contraindications listed in the Instructions For Use (IFU).
They must provide written informed consent with appropriate documentation noted in source documentation (prospective cohort only).