Trial document




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  DRKS00013166

Trial Description

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Title

Functional midterm follow-up (2-11 years) comparison of stemless total shoulder prostheses versus conventional stemmed anatomic shoulder prostheses using a 3D-motion-analysis

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The aim of this study is to compare the functional midterm outcome of stemless shoulder prostheses with standard anatomical stemmed shoulder prostheses.

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Brief Summary in Scientific Language

The aim of this study is to compare the functional midterm outcome of stemless shoulder prostheses with standard anatomical stemmed shoulder prostheses and to show that the STEMLESS results are comparable to the STEMMED with respect to active maximum range of shoulder motion (ROM) and Constant score (CS).

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Organizational Data

  •   DRKS00013166
  •   2017/10/23
  •   [---]*
  •   yes
  •   Approved
  •   S-657/2015, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   M19.91 -  [generalization M19.9: Arthrosis, unspecified]
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Interventions/Observational Groups

  •   Group of stemless prostheses, 3-D-motion Analysis at one Point of time, clinical examination, ascertainment of the constant score
  •   group of Standard anatomical shoulder protheses, the same Investigation like Arm 1
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

Functional midterm follow-up (2-11 years) comparison of stemless total shoulder prostheses versus conventional stemmed anatomic shoulder prostheses using a 3D-motion-analysis at one Point of time and survey of the constant score at one Point of time

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/10/17
  •   17
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Inclusion criteria were diagnosis with primary glenohumeral osteoarthritis with an intact rotator cuff. A stemless shoulder prosthesis or a conventionel shoulder prosthesis must be implanted

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Exclusion Criteria

Exclusion criteria were previous operations at the shoulder (except the implantation of a conventionell/ stemlsess shoulder prosthesis) and rotator cuff tears.

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Addresses

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    • Orthopädische Universitätsklinik Heidelberg
    • Schlierbacher Landstraße 200a
    • 69118  Heidelberg
    • Germany
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    •   062215634802
    •   0622156000
    •   [---]*
    •   [---]*
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    • Orthopädische Universitätsklinik Heidelberg
    • Mr.  Dr.med.  David  Spranz 
    • Schlierbacher Landstraße 200a
    • 69118  Heidelberg
    • Germany
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    • Orthopädische Universitätsklinik Heidelberg
    • Mr.  Dr.med.  David  Spranz 
    • Schlierbacher Landstraße 200a
    • 69118  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Orthopädische Universitätsklinik Heidelberg
    • Schlierbacher Landstraße 200a
    • 69118  Heidelberg
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2017/10/19
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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.