Trial document




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  DRKS00000830

Trial Description

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Title

outcome of elderly hip fracture patients

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Trial Acronym

[---]*

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URL of the Trial

http://reha.medizin.uni-ulm.de

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Brief Summary in Lay Language

The study investigates, if the recovery of independence after 4 month is influenced by orthogeriatric treatment starting before or in the first days after the operation. The study examinates patients more than 70 years with a fracture of the thight bone at the hip.

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Brief Summary in Scientific Language

BACKGROUND: In Germany 92665 hip fracture patients aged > 60 years received an operation in 2008. 1/3 are transfered to inpatient rehabilitation, although 2/3 lived at home before. ¼ of the preinjury independent patients are institutionalised four month after. Orthogeriatric units and cooperations are initiated for geriatric hip fracture patients to further independence in activities of daily living and the return to the prefracture surroundings.
NULL HYPOTHESIS: The common orthogeriatric treatment of geriatric patients has no influence at the independence at 120 days after surgery.
DESIGN: Prospective, quasi-randomized, longitudinal, multicenter study with three treatment groups: A ortho-geriatric units – B orthogeriatric cooperations – C standard (control group).
SUBJECTS: Proximal femur fracture patients ≥70 years, admitted to trauma surgery.
METHODS: Treatment protocol survey and telephone interview 120 day after surgery.
OUTCOME: Primary endpoint is the return to preinjury living environment. Secondary objectives are recovery level of mobility, time of geriatric treatment, rehabilitation period, rehospitalization rate, care, education and frailty.

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Organizational Data

  •   DRKS00000830
  •   2012/03/12
  •   [---]*
  •   yes
  •   Approved
  •   43/11, Ethik-Kommission der Universität Ulm
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Secondary IDs

  •   U1111-1120-8494 
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Health Condition or Problem studied

  •   S72.0 -  Fracture of neck of femur
  •   S72.1 -  Pertrochanteric fracture
  •   S72.2 -  Subtrochanteric fracture
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Interventions/Observational Groups

  •   Model of integrative trauma-surgeon-orthogeriatric treatment perioperatively (orthogeriatric multidisciplinary early rehabilitation at trauma ward perioperatively): patient is treated by orthogeriatric daily starting at admission or until 3 days after surgery
  •   Model of orthogeriatric cooperation: patient recieves a ward round by geriatrician at trauma ward at least one time untill day 8 after surgery
  •   Model of trauma ward without orthogeriatric cooperation: no treatment by geriatrician perioperatively untill day 8 = usual care at trauma ward = Standard
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Characteristics

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

recovery independence 120 day after surgery, messured in the clinical endpoint of the return to preinjury living environment: own score, day 0, treatment protocol and day 120, telephone interview

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Secondary Outcome

Recovery level of mobility: new mobility score, day 120, telephone interview.

Time of geriatric treatment: date, treatment protocol.

Rehabilitation period: date start-end, type, treatment protocol.

Rehospitalization rate, reason untill day 120, telephone interview.

Care: day 120, telephone interview.

Education: Score, day 8, treatment protocol.

Frailty: SHARE-Frailty Instrument, day 8, treatment protocol.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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

  •   Planned
  •   2013/01/01
  •   1500
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

PATIENTS ≥70 years AND proximal femur fracture AND trauma surgery AND informed consent. HOSPITAL: authority to education in traumalogy AND consent

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Exclusion Criteria

PATIENTS:
1. periimplant femur fracture
2. periprosthetic femur fracture
3. non-osteoporotic pathological femur fracture
4. proximal femur shaft fracture without trochanteric fracture.
HOSPITAL: ≤ 50 hip fracture patients per year

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Addresses

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    • AG Alterstraumatologie der Deutschen Gesellschaft für Orthopädie und Unfallchirurgie Diakonissenkrankenhaus Karlsruhe Klinik für Orthopädie und Unfallchirurgie
    • Mr.  Prof. Dr. med.  Erich  Hartwig 
    • Diakonissenstr. 28
    • 76199  Karlsruhe
    • Germany
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    • Forschungsinstitut für Rehabilitationsmedizin an der Universität Ulm Sitz: Therapiezentrum Federsee
    • Mr.  Dr. biol. hum. Dipl.-Inform.  Rainer  Kaluscha 
    • Wuhrstr. 1 / 2
    • 88422  Bad Buchau
    • Germany
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    • Zentrum für Alterstraumatologie Klinik für Orthopädie und Unfallchirurgie Diakonissenkrankenhaus Karlsruhe
    • Ms.  Dr. med.  Sarwiga  Riem 
    • Diakonissenstr. 28
    • 76199  Karlsruhe
    • Germany
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    •   0721-889-8208
    •   0721-889-3926
    •   riem at bdc.de
    •   [---]*
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Sources of Monetary or Material Support

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    • AG Alterstraumatologie der Deutschen Gesellschaft für Orthopädie und Unfallchirurgie Geschäftsstelle
    • Mr.  Prof. Dr. med.  Erich  Hartwig 
    • Luisenstraße 58/59
    • 10117   Berlin
    • Germany
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Status

  •   Recruiting stopped after recruiting started
  •   [---]*
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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.