DRKS00017483CompletedNot Applicable
A prospective PMCF multicentre study analysing performance and safety outcome of the Affinis Glenoid vitamys uncemented in total shoulder arthroplasty
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mathys AG Bettlach
- Enrollment
- 75
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 Years to one (—)
- Sex
- All
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
- •-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
Investigators
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