Trial document





This trial has been registered retrospectively.
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  DRKS00012800

Trial Description

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Title

Gait analysis in elderly trauma patients undergoing surgery

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Postoperative weight-bearing restrictions following hip fracture surgery in the elderly are frequently prescribed and were considered as a treatment option that “may be appropriate” for the aftercare of hip fracture patients in the OrthoGuidelines 2015 of the AAOS (American Academy of Orthopaedic Surgeons). Yet, especially elderly hip fracture patients with reduced activity would benefit from early mobilization as weight bearing restrictions may lead to immobilization, which triggers various postoperative complications such as venous thromboembolism, pneumonia, urinary tract infections, pressure ulcers and others. It has already been shown that femoral fracture patients, permitted immediate postoperative full weight-bearing, had a significantly decreased total mortality, compared to patients treated with postoperative weight-bearing restrictions.
Weight bearing restrictions in patients with lower extremity fractures are attributed to a long believed fear of fracture fixation failure, if the osteosynthesis construct is loaded early. This fear might be associated with experimental results, which showed i.e. that a reduction of load transfer by delaying full weight-bearing is advantageous for the healing of fractures, stabilized with flexible fixation systems. Reduced bone quality in osteoporotic hip fracture patients is another surgical fixation challenge, which is likely to influence the surgeons’ instructions of aftercare.
Due to the demographic changes of our ageing population with a worldwide incidence of hip fractures increasing from 1.7 million per year in 1990 to 6.3 million per year in 2050, a better understanding of the postoperative mobilization in aged hip fracture patients is highly relevant. Secondly, the 1-year mortality in elderly hip fracture patients is still up to 30% whereas reduced mobility is associated with various declines in the quality of life and poor functional long term results.
Thus, the main goal of treatment in proximal femoral fracture patients is to preserve function and independency in activities of daily living.
Therefore, the comparative study is aiming to detect the true load in the early postoperative period of younger ankle fracture patients compared to elderly hip fracture patients. Further attempts of the study are to rule out weight-bearing differences depending on different operative strategies and the impact of fractures of the upper extremity. As the limited strength of elderly hip fracture patients is associated with conditions such as sarcopenia and other comorbidities, we hypothesized, that elderly hip fracture patients are not able to adequately follow weight-bearing restrictions.

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Organizational Data

  •   DRKS00012800
  •   2017/08/25
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  •   yes
  •   Approved
  •   214-16, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   S72 -  Fracture of femur
  •   S42 -  Fracture of shoulder and upper arm
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Interventions/Observational Groups

  •   Elederly trauma patients with postoperative weight bearing restrictions (<20kg) of the affected extremity. Therefore, patients are treated with 5 days of postoperative physiotherapy in which partial weight bearing is trained. Thereafter, gait analysis will be performed in which the real force applied to the extremity will be detected using an insole force sensor.
  •   Young trauma patients at the age of <40 years with postoperative partial weight bearing (<20kg) of the affected extremity. As in the elderly control group, patients are treated with 5 times of postoperative physiotherapy in which partial weight bearing is trained. Thereafter, gait analysis will be performed in which the real force applied to the extremity will be detected using an insole force sensor.
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Characteristics

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

During gait analysis the real force applied to the extremity will be detected using an insole force sensor (pedoped® load monitoring device), following 5 times of physiotherapy training.

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/07/15
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   100   Years
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Additional Inclusion Criteria

Patients undergoing treatment in the department of general, trauma and reconstruction surgery at the LMU with individually recommended postoperative weight-bearing

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Exclusion Criteria

Patients with poor cognition, dementia and other comorbidities

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Addresses

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    • Klinik für Allgemeine, Unfall- und Wiederherstellungschirurgie,Klinikum Großhadern,LMU München
    • Mr.  PD Dr.  Carl  Neuerburg 
    • Marchioninistr. 15
    • 81377  München
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    • Klinik für Allgemeine, Unfall- und Wiederherstellungschirurgie,Klinikum Großhadern,LMU München
    • Mr.  PD Dr.  Carl  Neuerburg 
    • Marchioninistr. 15
    • 81377  München
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    • Klinik für Allgemeine, Unfall- und Wiederherstellungschirurgie,Klinikum Großhadern,LMU München
    • Mr.  PD Dr.  Carl  Neuerburg 
    • Marchioninistr. 15
    • 81377  München
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Sources of Monetary or Material Support

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    • Friedrich-Baur-Stiftung
    • Theodor-Heuss-Str. 67
    • 96264  Altenkunstadt
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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