A study with the Affinis Inverse shoulder prosthesis with a ceramic inlay and a highly cross-linked polyethylene glenosphere
Organizational Data
- DRKS-ID:
- DRKS00025376
- Recruitment Status:
- Recruiting withdrawn (before recruiting started)
- Date of registration in DRKS:
- 2021-10-20
- Last update in DRKS:
- 2023-02-03
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
The Affinis Inverse shoulder prosthesis is used for total reversed shoulder arthroplasty to treat diseased shoulder joints.
Brief summary in scientific language
Total reversed shoulder arthroplasty (RTSA) is a surgical procedure undertaken to relieve pain and restore function of the shoulder joint. In this study, radiological outcome, clinical scores, complication and revision rates of a RTSA are assessed. All implant components bear the CE mark.
Health condition or problem studied
- ICD10:
- M19.0 - Primary arthrosis of other joints
- ICD10:
- M19.1 - Post-traumatic arthrosis of other joints
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 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.
Endpoints
- Primary outcome:
- Clinical and radiological follow-up 5-7 and 10 years after implantation, with documentation of any implant related complication or revision.
- Secondary outcome:
- none
Study Design
- Purpose:
- Treatment
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting withdrawn (before recruiting started)
- Reason if recruiting stopped or withdrawn:
- Change of Hospital Prinicipal Investigator
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Medical center Klinikum Marienstift Arnstadt Arnstadt
Recruitment period and number of participants
- Planned study start date:
- 2022-05-01
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 56
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional 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
Addresses
Primary Sponsor
- Address:
- Mathys AG BettlachRobert Mathys Strasse 52544 BettlachSwitzerland
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Mathys AG BettlachMarlen EggerRobert Mathys Strasse 52544 BettlachSwitzerland
- Telephone:
- +41 32 644 16 44
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Mathys AG BettlachMarlen EggerRobert Mathys Strasse 52544 BettlachSwitzerland
- Telephone:
- +41 32 644 16 44
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Mathys AG BettlachMarlen EggerRobert Mathys Strasse 52544 BettlachSwitzerland
- Telephone:
- +41 32 644 16 44
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Robert Mathys Strasse 52544 BettlachSwitzerland
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Landesärztekammer ThüringenIm Semmicht 3307751 JenaGermany
- Telephone:
- +49-3641-614201
- Fax:
- +49-3641-614209
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-08-18
- Ethics committee number:
- 72376
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-09-21
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry