Идёт набор NCT05035693

Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C

Без фазы С лечением Discopathy Herniated Cervical Disc Stenoses, Spinal Radiculopathy

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: MOVE®-C.
Кому может быть актуально: Состояния в реестре: Discopathy, Herniated Cervical Disc, Stenoses, Spinal, Radiculopathy. 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: Австрия, Германия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

"PMCF MOVE®-C" International, Prospective, Multicentre, Non-randomised Post-market Clinical Follow-up Study Clinical and Radiological Outcome After Mono- and Bisegmental Cervical Intervertebral Disc Prosthetics

Обзор

Study design: International, prospective, multicentre, non-randomised, observational study according to § 23b MPG. Objectives: Observational study to confirm the safety and performance of the cervical disc prosthesis MOVE®-C.

Подробное описание

This clinical investigation is conducted to gain post market results on the Cervical Disc Prosthesis MOVE®-C and to demonstrate the safety and performance. Besides, it is aimed to gain knowledge concerning the development of patients' quality of life (QoL) after the implantation of the Cervical Disc Prosthesis MOVE®-C and to collect data for the analysis of the range of motion (ROM), which is an essential parameter for motion-preserving implants.

Вмешательства

Устройство MOVE®-C
Momo- or bisegmental implantation of MOVE®-C cervical prothesis.

Первичные конечные точки

Improvement from baseline on Neck Disability Index (NDI) [Срок оценки: Baseline and month 24]
Improvement from baseline on Visual Analogue Scales (VAS arm/neck) [Срок оценки: Baseline and month 24]

Вторичные конечные точки (6)

Change from baseline in Core Outcome Measure Index (COMI neck) [Срок оценки: Baseline and months 24]
Change from baseline in Short Form 36 Health Survey Questionnaire (SF-36) [Срок оценки: Baseline and moths 24]
Change from baseline in EuroQoL (EQ-5D-5L) [Срок оценки: Baseline and moths 24]
Change from baseline in Japanese Orthopedic Association Score (JOA) [Срок оценки: Baseline and moths 24]
Analyse of the Range of Motion (ROM) [Срок оценки: Baseline and moths 24]
Monitoring of product related occurence of adverse events (AE-Monitoring) [Срок оценки: Baseline and moths 24]

Критерии участия

Критерии включения

Diagnosis of discopathy or disc hernia with radiculopathy or stenosis of the foramen and spinal canal,
documented individual history of neck and/or upper extremity pain and/or functional/neurological deficit associated with the cervical level to be treated,
no surgical treatment regarding the planned index surgery within the last six weeks prior implantation,
unsuccessful conservative medical care regarding the indication within the last six weeks,
age ≥18 years,
patient must agree to fully participate in the clinical trial and give informed consent in writing,
patient is capable to realise the nature, aims and possible consequences of the clinical trial (MPG §20.2.1),
patient information has been provided and all written consents of the patient are available.

Критерии исключения

Known contraindication against the use of cervical intervertebral disc prostheses in accordance with the manufacturer's instructions for use:

Bone mineral density with T-score ≤ -1.5 as determined by spine DXA if male ≥ 60 years of age or female ≥ 50 years of age,
active systemic infection or infection at the operative site,
sustained osteoporotic fracture of the spine, hip or wrist,
spinal metastases,
known allergy to titanium or polycarbonate-urethane,
confirmed pregnancy,
severe cervical myelopathy,
patients requiring a treatment that destabilises the spine (e.g. posterior element decompression),
advanced cervical anatomical deformity at the operative site (e.g. ankylosing spondylitis, scoliosis),
advanced degenerative changes (e.g. spondylosis) at the index vertebral level,
patient is kept in an institution under judicial or official orders (MPG §20.3).

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

Здоровые добровольцы: Да