Trial document

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DRKS-ID: DRKS00017483

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

http://-

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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

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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

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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

DRKS-ID: DRKS00017483
Date of Registration in DRKS: 2019/07/26
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): no
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 68/19, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg

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Secondary IDs

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Health Condition or Problem studied

ICD10: M19.0 - Primary arthrosis of other joints
ICD10: M19.1 - Post-traumatic arthrosis of other joints
ICD10: M19.2 - Other secondary arthrosis

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Interventions/Observational Groups

Arm 1: 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.

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Characteristics

Study Type: Non-interventional
Study Type Non-Interventional: Observational study
Allocation: Single arm study
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Uncontrolled/Single arm
Purpose: Treatment
Assignment: Single (group)
Phase: IV
Off-label Drug use: N/A

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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)

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Secondary Outcome

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

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Countries of Recruitment

DE: Germany

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Locations of Recruitment

University Medical Center Otto-von-Guericke-Universität, Magdeburg
Medical Center Sporthopaedicum Straubing, Straubing
Medical Center HELIOS Park-Klinikum Leipzig, Leipzig
Medical Center OCC Tübingen, Tübingen
Medical Center Marienstift Arnstadt, Arnstadt

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2020/01/16
Target Sample Size: 75
Monocenter/Multicenter trial: Multicenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: no maximum age

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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

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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

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Addresses

Primary Sponsor
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- Mathys AG Bettlach
- Ms. N/A Marlen Egger
- Robert Mathys Strasse 5
- 2544 Bettlach
- Switzerland
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- Telephone: +41 32 644 1429
- Fax: N/A
- E-mail: Marlen.Egger at mathysmedical.com
- URL: http://www.mathysmedical.com
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Contact for Scientific Queries
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- Otto-von-Guericke-Universität
- Mr. Dr. Alexander Berth
- Leipziger Strasse 44
- 39120 Magdeburg
- Germany
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- Telephone: +49 391 671 4034
- Fax: N/A
- E-mail: alexander.berth at med.ovgu.de
- URL: http://N/A
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Contact for Public Queries
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- Mathys Orthopädie GmbH
- Ms. Natividad Zeleny
- Seilfahrt 99
- 44809 Bochum
- Germany
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- Telephone: +49 170 572 2702
- Fax: [---]*
- E-mail: natividad.zeleny at mathysmedical.com
- URL: [---]*
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Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)
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- Mathys AG Bettlach
- Ms. Marion Röthlisberger
- Robert Mathys Strasse 5
- 2544 Bettlach
- Switzerland
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- Telephone: +41 32 644 15 26
- Fax: [---]*
- E-mail: marion.roethlisberger at mathysmedical.com
- URL: http://www.mathysmedical.com
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Status

Recruitment Status: Recruiting ongoing
Study Closing (LPLV): [---]*

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Trial Publications, Results and other Documents

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