M16.1 M16.7
Conditions
Interventions
Group 1: All subjects will undergo knee arthroplasty surgery using the balanSys UNI Fix knee prosthesis with vitamys Inlay (Mathys, Bettlach, CH). Radiological and clinical assessment will be performe
Sponsors
Mathys AG Bettlach
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study will be the NKSS. For assessment of the primary endpoint, the NKSS is assessed at 24 months postoperative. However, the score is additionally recorded pre-operative and several times post-operative. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following additional data shall be evaluated: i) Clinical performance: NKSS, UCLA Activity Score, EQ-5D-5L, FJS ii) Radiological outcome: Radiolucent lines, Resorption, Osteolysis, Component alignment, Anatomical axis iii) Demographic data (recorded presurgical) | — |
Countries
Germany
Contacts
Public ContactCamilla Vianello
Mathys AG Bettlach
Outcome results
None listed