M19.0 M19.1 M19.2
Conditions
Interventions
Group 1: Single-arm prospective observational multicentre study of the Affinis Glenoid vitamys. Clinical and radiological follow-ups are taking place after 6 weeks, 6, 12, 24 Months and 5, 7 and 10 ye
Sponsors
Mathys AG Bettlach
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: -Informed consent form (signed by participant and investigator) - Primary implantation - Primary osteoarthritis, secondary osteoarthritis, fracture sequelae, avascular necrosis of the humeral head - Age at inclusion >18 years - Intact rotator cuff - Preoperative Constant Score >20 points - Glenoid <15° retroversion and <70% humeral head subluxation
Exclusion criteria
Exclusion criteria: -Missing consent - Rheumatoid arthritis - Known or suspected non-compliance (e.g. drug or alcohol abuse) - Revision surgery - Presence of sepsis or malignant tumours - Chemotherapy treatment within 6 months before surgery - >5mg/day of corticosteroids, excluding inhalers, within 3 months before surgery - Women who are pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the assessment of the radiolucent lines of the Affinis Glenoid vitamys uncemented at two years after surgery. Clinical and radiological examination with two radiographs (anterior-posterior and axial view) | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints of the study are the clinical outcomes and complications at two years after surgery. | — |
Countries
Germany
Contacts
Public ContactNatividad Zeleny
Mathys Orthopädie GmbH
Outcome results
None listed