A study with the Affinis Inverse shoulder prosthesis with a ceramic inlay and a highly cross-linked polyethylene glenosphere

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

• Registration Number: DRKS00025376
• Lead Sponsor: Mathys AG Bettlach

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting withdrawn before recruiting started
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Informed consent form (signed by participant and investigator)
- Patients having a Affinis Inverse prosthesis with an Affinis Inverse Inlay ceramys and an Affinis inverse Glenosphere vitamys in situ for more than five years.

Exclusion Criteria

- Missing informed consent form
- Known or suspected non-compliance (e.g. drug or alcohol abuse)
- Enrolment of the investigator, his/her family, employees and other dependent persons
- Patients younger than 18 years
- Presence of sepsis or malignant tumours
- Pregnancy

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical and radiological follow-up 5-7 and 10 years after implantation, with documentation of any implant related complication or revision.