A prospective PMCF multicentre study analysing performance and safety outcome of the Affinis Glenoid vitamys uncemented in total shoulder arthroplasty

• Conditions: M19.0; M19.1; M19.2; Primary arthrosis of other joints; Post-traumatic arthrosis of other joints; Other secondary arthrosis

• Registration Number: DRKS00017483
• Lead Sponsor: Mathys AG Bettlach

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The secondary endpoints of the study are the clinical outcomes and complications at two years after surgery.