Trial document
DRKS00017483
Trial Description
Title
A prospective PMCF multicentre study analysing performance and safety outcome of the Affinis Glenoid vitamys uncemented in total shoulder arthroplasty
Trial Acronym
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URL of the Trial
Brief Summary in Lay Language
The Affinis Glenoid vitamys uncemented is used in total shoulder arthroplasty to treat diseased shoulder joints.
Mid- to long-term safety and performance of the Affinis Glenoid vitamys uncemented shall be investigated
Brief Summary in Scientific Language
A prospective PMCF multicentre study analysing performance and safety outcome of the Affinis Glenoid vitamys uncemented in total shoulder arthroplasty
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00017483
- 2019/07/26
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- no
- Approved
- 68/19, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
Secondary IDs
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Health Condition or Problem studied
- M19.0 - Primary arthrosis of other joints
- M19.1 - Post-traumatic arthrosis of other joints
- M19.2 - Other secondary arthrosis
Interventions/Observational Groups
- Single-arm prospective observational multicentre study of the Affinis Glenoid vitamys. Clinical and radiological follow-ups are taking place after 6 weeks, 6, 12, 24 Months and 5, 7 and 10 years.
Characteristics
- Non-interventional
- Observational study
- Single arm study
- Open (masking not used)
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- Uncontrolled/Single arm
- Treatment
- Single (group)
- IV
- N/A
Primary Outcome
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
The secondary endpoints of the study are the clinical outcomes and complications at two years after surgery.
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
Recruitment
- Actual
- 2020/01/16
- 75
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional 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
Addresses
-
start of 1:1-Block address primary-sponsor
- Mathys AG Bettlach
- Ms. N/A Marlen Egger
- Robert Mathys Strasse 5
- 2544 Bettlach
- Switzerland
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- +41 32 644 1429
- N/A
- Marlen.Egger at mathysmedical.com
- http://www.mathysmedical.com
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Otto-von-Guericke-Universität
- Mr. Dr. Alexander Berth
- Leipziger Strasse 44
- 39120 Magdeburg
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49 391 671 4034
- N/A
- alexander.berth at med.ovgu.de
- http://N/A
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Mathys Orthopädie GmbH
- Ms. Natividad Zeleny
- Seilfahrt 99
- 44809 Bochum
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49 170 572 2702
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- natividad.zeleny at mathysmedical.com
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end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Mathys AG Bettlach
- Ms. Marion Röthlisberger
- Robert Mathys Strasse 5
- 2544 Bettlach
- Switzerland
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- +41 32 644 15 26
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- marion.roethlisberger at mathysmedical.com
- http://www.mathysmedical.com
end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
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