shoulder arthoplasty total shoulder replacement
Conditions
Interventions
None listed
Sponsors
Amphia Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Primary TSA implantation Primary osteoarthritis, secondary osteoarthritis, fracture sequelae, avascular necrosis of the humeral head Age at inclusion >18 years Intact rotator cuff Glenoid retroversion <15% and <70% humeral head subluxation (Walch type A1, A2, B1, B2 glenoid)
Exclusion criteria
Exclusion criteria: Missing consent Rheumatoid athritis 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 Glenoid retroversion >15% (Walch type C glenoid)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the survival RLL score according to Molé at five years of the Uncemented uncemented Glenoid Affinis Vitamysvitamys. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints of the study are the clinical outcomes and performance of the Uncemented Glenoid Affinis Vitamys, complication rate after surgery, and patients reported outcome measures (PROMS) pre-operative as well as post-surgery. The final endpoint is the product survival rate of the Uncemented Glenoid Affinis Vitamys at ten years. | — |
Countries
Netherlands
Outcome results
None listed