Trial document




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  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

  •   DRKS00017483
  •   2019/07/26
  •   [---]*
  •   no
  •   Approved
  •   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

  •   M19.0 -  Primary arthrosis of other joints
  •   M19.1 -  Post-traumatic arthrosis of other joints
  •   M19.2 -  Other secondary arthrosis
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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.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   IV
  •   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

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2020/01/16
  •   75
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   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

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    • Mathys AG Bettlach
    • Ms.  N/A  Marlen  Egger 
    • Robert Mathys Strasse 5
    • 2544  Bettlach
    • Switzerland
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    • Otto-von-Guericke-Universität
    • Mr.  Dr.  Alexander  Berth 
    • Leipziger Strasse 44
    • 39120  Magdeburg
    • Germany
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    • Mathys Orthopädie GmbH
    • Ms.  Natividad  Zeleny 
    • Seilfahrt 99
    • 44809  Bochum
    • Germany
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Sources of Monetary or Material Support

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    • Mathys AG Bettlach
    • Ms.  Marion  Röthlisberger 
    • Robert Mathys Strasse 5
    • 2544  Bettlach
    • Switzerland
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.