Trial document




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  DRKS00006110

Trial Description

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Title

Clinical results using screw augmented Philos plateosteosynthesis in proximal humerus fractures.

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

A stable fixation is difficult to reach in fractures of the proximal humerus with poor bone quality or osteoporotic bone. This can result in implant failure with loss of fixation und secondary screw perforation. The injection of cement through the inserted screws (augmentation) increases the stability of the fixation in osteoporotic bone. While the increase of stability is already proved in laboratories, this study evaluates the clinical results in patients with augementated screws in proximal humerus fractures.

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Brief Summary in Scientific Language

Proximal humerus fractures can be treated with open reduction and internal fixation with plate osteosynthesis. Limited stability in poor bone quality or osteoporotic bone can result in fixation failure and secondary screw perforation. Biomechanical studies show an enhanced stability and anchorage in low density bone by injecting cement through the inserted screws. The purpose of this study is to collect and evaluate clinical results after cement augmentation in proximal humerus fractures.

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Organizational Data

  •   DRKS00006110
  •   2014/05/09
  •   [---]*
  •   yes
  •   Approved
  •   2222-2014, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   S42.20 -  [generalization S42.2: Fracture of upper end of humerus]
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Interventions/Observational Groups

  •   Philos screw augmentation in proximal humerus fractrues - clinical results.

    The Department of Traumatology of the Friederikenstift Hannover is performing a prospective
    follow-up examination on patients with proximal humerus fractures who received a philos plate osteosynthesis with screw augmentation. The follow-up examination is taking place after 3 and 12 months. The purpose of this study is to collect and evaluate clinical short- and midterm results after cement augmentation in proximal humerus fractures.


    Information about patient satisfaction und pain is collected. The active and passive range of
    motion measures the functional outcome of the shoulder. Subjective and objective shoulder
    scores (CS, SSS, SSV) are evaluated, complications analysed and revision operations
    registered. Therefore besides the patient survey a clinical examination and evaluation of the
    patient’s medical history is performed and pre- and post-operative x-rays are analysed.
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Characteristics

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

After 3 months: evaluation of short-term results based on therapy failure, complications and
clinical result. Therefore a postoperative patient history, clinical examination, Constant-Score, age
corrected Constant-Score, Simple-Shoulder-Score and Subjective Shoulder Value are required.

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Secondary Outcome

After 12 months: evaluation of mid-term results based on therapy failure, complications and
clinical result. Therefore a postoperative patient history, clinical examination, Constant-Score, age
corrected Constant-Score, Simple-Shoulder-Score and Subjective Shoulder Value are required

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2014/05/01
  •   35
  •   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

Indication for surgery of a proximal humerus fracture and internal fixation with philos plate osteosynthesis with additional screw augmentation, sufficient patient compliance, existence of a signed study consent form after oral and written education.

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Exclusion Criteria

Preexisting injuries, which affect motion or strength of the shoulder, pre-operation of the affected shoulder, a immunsuppressive therapy, drug or alcohol abuse, missing patient agreement, absence of compliance or legal incompetence.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Friederikenstift Hannover, Abteilung Unfall- und Wiederherstellungschirurgie
    • Mr.  Prof. Dr.  Helmut  Lill 
    • Humboldtstr. 5
    • 30169  Hannover
    • Germany
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    • Friederikenstift Hannover, Abteilung Unfall- und Wiederherstellungschirurgie
    • Mr.  Dr.  Christoph  Katthagen 
    • Humboldtstr. 5
    • 30169  Hannover
    • Germany
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    • Friederikenstift Hannover, Abteilung Unfall- und Wiederherstellungschirurgie
    • Mr.  Dr.  Christoph  Katthagen 
    • Humboldtstr. 5
    • 30169  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Friederikenstift Hannover, Abteilung Unfall- und Wiederherstellungschirurgie
    • Mr.  Prof. Dr.  Helmut  Lill 
    • Humboldtstr. 5
    • 30169  Hannover
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/09/30
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Trial Publications, Results and other Documents

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