Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00007548

Trial Description

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Title

Buttonfixation ot the long head of the biceps- clinical follow-up

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Trial Acronym

BIZBUTTON

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URL of the Trial

[---]*

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Brief Summary in Lay Language

clinical prospective case series after performing mini-open or arthroscopic tenodesis (fixation) of the Long head of the biceps (LHB) with suture button technique.
There are many kinds of fixation techniques for the LHB. The used technique in this study is a suture plate unicortial suprapectoral fixation. This means that a suture plate (titan) is put below the cortical bone of the groove in which the LHB usually is running. Onto the button, the before cut LHB is sutured to the groove. The technique is biomechanically tested. The study controls cosmesis, functional results, patients´ satisfaction strength and sonographic controls.

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Brief Summary in Scientific Language

clinical prospective case series of mini-open or arthroscopically done biceps tenodesis using an unicortial fixation via suture button.
Scheibels BicepsScore, Constant Score, Satisfaction and cosmesis were recorded pre- 6 and 52 weeks post-op. also ultrasound controls were performed

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Organizational Data

  •   DRKS00007548
  •   2015/01/07
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  •   yes
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Secondary IDs

  •   U1111-1164-6045 
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Health Condition or Problem studied

  •   M75.2 -  Bicipital tendinitis
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Interventions/Observational Groups

  •   prospective case series of isolated LHB-tenodesis. no controll-group.
    Scheibels LHB-Score, Constant-Score, Cosmesis, Satisfaction, force messuring using an isoforce control. Also sonographic controls were done. Examinations performed pre-OP, 6 and 52 weeks post-op.
    an xray was done after 6 weeks
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

acquiring constant score, Scheibels LHB Score (shoulder function) and patients satisfaction pre, 6 weeks and 52 weeks after operation.
Clinical controls and questionnaire based scores.
Sonographic controlls. Single xray control 6 weeks post-op

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2013/10/01
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

all kind of indication for biceps tenodesis: SLAP-Lesion, Tendonitis, partial rupture, Biceps Instabilität.

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Exclusion Criteria

addiitonal rotatorcuff repair

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Addresses

  • start of 1:1-Block address primary-sponsor
    • St. VInzenz-Klinik Pfronten
    • Mr.  Dr.  Christian  Schoch 
    • Kirchweg 15
    • 87459  Pfronten
    • Germany
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    • St. Vinzenz Klinik Pfronten
    • Mr.  Dr.med.  Christian  Schoch 
    • Kirchweg 15
    • 87459  Pfronten
    • Germany
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Sources of Monetary or Material Support

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    • St. Vinzenz Klinik Pfronten
    • Mr.  Dr.med.  Christian  Schoch 
    • Kirchweg 15
    • 87459  Pfronten
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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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.