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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00025376

Enrollment

Registered

2021-10-20

Start date

2022-05-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M19.0 M19.1

Interventions

Group 1: Total inverse shoulder prosthesis with a ceramic inlay and a vitamys glenosphere, clinical and radiological follow-up examinations are performed after 5, 7 and 10 years.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

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

Countries

Germany

Contacts

Public ContactMarlen Egger

Mathys AG Bettlach

clinicals@mathymedical.com+41 32 644 16 44

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026