Trial document





This trial has been registered retrospectively.
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  DRKS00000524

Trial Description

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Title

Effectiveness of the hip protector Safe Hip Soft on the incidence of hip fractures in frail patients of an acute geriatric unit

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Fractures of the hip are among the most serious events in the elderly. The prevention of falls and protection from the consequences of a fall are among the preventive measures. One concept of prevention is the use of hip protectors to reduce the frequencies of fall related hip fractures. However, the effectiveness of such hip protectors has never been studied for geriatric in-hospital patients. Furthermore, the acceptance of such a device is unclear.
We therefore investigated the efficacy and the acceptance of hip protectors in patients of a geriatric acute hospital.

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Brief Summary in Scientific Language

Prospective, randomized, multicenter (3 centers) controlled and open trial to measure the effectiveness of the hip protector (HP) Safe-Soft on the incidence of hip fracture geriatric in-hospital patients.
Two-arm study with randomized allocation to an intervention group (HP) or a control group (no HP). Eligible are patients with a recent fall event in the last three months and reduced activities of daily living (measured by the Barthel-Index, BI) with a BI of less than 70 points [0-100].
The scheduled number of patients is 500 per group.
The main objective is the number of hip fractures in both groups. A secondary aim is to assess the adherence to the hip protector.

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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

  •   DRKS00000524
  •   2010/09/16
  •   [---]*
  •   yes
  •   Approved
  •   2712, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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Secondary IDs

  •   U1111-1116-7179 
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Health Condition or Problem studied

  •   patients of an acuts geriatric unit at risk of falls
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Interventions/Observational Groups

  •   Group 1 (Intervention group): application of a hip protector that should be worn for 24 hours during the hospital stay
  •   Group 2 (controls): geriatric treatment according to the rules of good medical practice, no application of a hip protector
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Prevention
  •   Parallel
  •   IV
  •   [---]*
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Primary Outcome

rate of a hip fracture

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Secondary Outcome

Acceptance of the hip measured three times daily (morning, afternoon, night) by a nurse. Patients are regarded as compliant, if the portector is worn at all three times.

Days with full compliance are summarized and divided by the time in the study.
A rate of more than 80% is indicative of good compliance.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2007/01/01
  •   1000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   65   Years
  •   100   Years
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Additional Inclusion Criteria

-geriatric in-hospital patients
-recent fall within the last 3 month
-reduced activities of daily living with a Barthel Index (BI) of lass than 70 points [0-100]
-written informed consent

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Exclusion Criteria

-subjects in the terminal phase of life,
-missing written informed consent,
-no a fall in the last 3 month
-more than 70 Points in Barthel-Index

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Kliniken Essen Mitte Zentrum für Altersmedizin
    • Mr.  Dr. med.  Helmut  Frohnhofen 
    • Am Deimelsberg 34a
    • 45276  Essen
    • Germany
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    • Kliniken Essen Mitte Zentrum für Altersmedizin
    • Mr.  Dr. med.  Helmut  Frohnhofen 
    • Am Deimelsberg 34a
    • 45276  Essen
    • Germany
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    • Kliniken Essen Mitte Zentrum für Altersmedizin
    • Mr.  Dr. med.  Helmut  Frohnhofen 
    • Am Deimelsberg 34a
    • 45276  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Verwaltungsberufsgenossenschaft Duisburg
    • Wittgensstr. 27
    • 47058  Duisburg
    • Germany
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    •   0203-34870
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2011/01/31
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Trial Publications, Results and other Documents

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