Post-market clinical follow-up with the balanSys UNI vitamys Fix

Mathys AG Bettlach0 个研究点目标入组 105 人开始时间: 2020年1月14日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•The patient…
•- has given his/her written consent to participate after having been fully informed (informed consent of the patient)
•- is a candidate for a primary unicondylar knee endoprosthesis (medial)
•- suffers from a painful and / or disabling unicompartmental joint disease in the medial femorotibial compartment resulting from osteoarthritis, avascular necrosis, or post-traumatic arthritis
•- is willing to participate in the follow-up examinations mentioned

•The patient meets at least one of the following criteria:
•- Local or general infection
•- Any soft tissue, ligament, nerve or vessel insufficiency that might lead to an unacceptable risk of prosthesis instability, prosthesis fixation failure and/or complications in post-operative care
•- Insufficiency of the extensor mechanism
•- Compromised bone stock due to bone loss or bone defects and/or insufficient bone substance, which cannot provide adequate support and/or fixation for the prosthesis
•- Hypersensitivity to materials used
•- Insufficiency of the ACL and/or PCL
•- Earlier valgus-producing osteotomy resulting in valgus >5°
•- Extension deficiency of >10°
•- Varus or valgus deformity of >10°
•- Genu recurvatum
•- Degenerative disease of other compartments
•- Systemic inflammatory arthritis
•- Progressive neoplastic disease
•- Is pregnant, desires to have children or is in the breast-feeding period during the study period
•- Skeletal immaturity
•- Patient age < 18 years
•- Has known or suspected non-compliance (e.g. drug alcohol abuse or non-compliance of secondary treatment or medical advice)
•- Simultaneous participation in another clinical study or documentation with medical devices or drugs which could have an influence on the current study
•- Enrolment of the investigator, his/her family, employees (MAB/ investigational site) and other dependent persons
•- Does not speak German

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