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Активно (без набиране) NCT03423953

Comprehensive Nano - Post Market Clinical Follow-Up Study

Заболявания: Osteoarthritis Avascular Necrosis Rheumatoid Arthritis Revision Correction of Functional Deformity

Спонсор: Zimmer Biomet

Налично на: БГ
Обобщение
This data collection project is intended to provide clinical outcomes data to engineering, marketing as well as fulfill the post market surveillance requirements of various regulatory authorities. The study will be a prospective and one-arm.
Описание
The Comprehensive® Shoulder System with Nano humeral component is a humeral prosthesis system intended for use in total or hemi shoulder arthroplasty surgery. Total shoulder arthroplasty consists of replacement of the humeral head and glenoid. Hemi-arthroplasty consists of replacement of only the humeral head. This project is a prospective study including one-hundred and fifty (150) anatomic and hemi cases and 44 reverse shoulders collected from up to ten (10) sites. All potential study subjects will be required to participate in the Informed Consent process.
Кой може да участва
Inclusion Criteria: * Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. * Rheumatoid arthritis * Revision where other devices or treatments have failed * Correction of functional deformity. * Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate * Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate Exclusion Criteria: * Infection * Sepsis * osteomyelitis
Интервенции
Comprehensive Nano
DEVICE
Места на провеждане 5
Австрия (1)
Privatklinik Leech
Graz , Styria
Канада (1)
Kingston General Hospital
Kingston , Ontario
Южна Корея (2)
Chonnam National University Hospital
Gwangju , Gwangju
Samsung Medical Centre
Seoul , Seoul
Великобритания (1)
University of Liverpool
Liverpool , Merseyside
Технически детайли
Статус
Активно (без набиране)
Вид изследване
OBSERVATIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
30.10.2013
Крайна дата
31.07.2030
Регистрационен номер
NCT03423953
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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