Trial document




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  DRKS00003485

Trial Description

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Title

Clinical study to assess long-term functional outcome and quality of life following different rehabilitation measures and the relation to anatomical reconstruction in patients with calcaneus fracture

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This study consists of two parts.

First part is the assessment of functional outcome following surgery of calcaneus fracture. The results of different types of rehabilitation are compared. Background of the study is a long healing period and many complications after calcaneus fractures. The trial question is: Does the in-patient rehabilitation after an occupational accident result in a better functional outcome compared to outpatient rehabilitation supported by compulsory health insurance. Primary outcome is the pressure distribution in the foot. Included are patients with calcaneus fracture treated at Trauma Center Murnau.

The second part is the construction of a three dimensional model of the fractured and non-fractured foot with data from the radiographics. A geometrical value for the anatomical reconstruction should be developed to assess the relationship between anatomical reconstruction and functional outcome.

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Brief Summary in Scientific Language

This study assesses the functional outcome following surgery of intraarticular calcaneus fractures. The primary objective is: Does the in-patient rehabilitation after an occupational accident result in a better functional outcome than the measures supported by compulsory health insurance. Secondary objective is: How can anatomical reconstructon be quantified and is it related to functional outcome. Primary endpoint is plantar pressure distribution measured by pedobarography. Secondary endpoint is the development of geometrical values to assess anatomical reconstruction. Included are 128 patients treated at Trauma Center Murnau. The second part is performed with CT data of 42 patients used for a 3D model of both feet.

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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

  •   DRKS00003485
  •   2012/01/26
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  •   yes
  •   Approved
  •   11041, Ethik-Kommission der Bayerischen Landesärztekammer
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Secondary IDs

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Health Condition or Problem studied

  •   S92.0 -  Fracture of calcaneus
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Interventions/Observational Groups

  •   In-patient rehabilitation (employers liability insurance covarage) for 4-6 weeks
  •   out-patient rehabilitation (compulsory health insurance) for about 3 weeks
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Pedobarography: Size of vertical component of reaction force of fractured and non-fractured foot (symmetric load) after 6 months

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Secondary Outcome

Joint adaption during anatomical reposition (CT data of fractured and non-fractured foot in mm2, angle: degrees) 3 months postop., AOFAS Score (American Orthopedic Foot and Ankle Society) to assess pain function,gait and range of motion at 3, 6,12 and 24 months
SF-36 Score to assess quality of life with the evaluation of physical and mental health and EQ-5D Score (3,6,12,24 months), complications during 24 months,
period of disability during 24 months
Muscle structure Parameters (Fascicle Angle, Fascicle Length)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2012/03/12
  •   128
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Intraarticular calcaneus fracture: fracture type joint depression or tongue-type
Surgery at Murnau Tauma Center with open reduction and osteosynthesis with screw or plate

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Exclusion Criteria

open fracture, polytrauma, pregnancy, complex regional pain syndrome, other severe medical disorder, other injury of lower extremity

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Addresses

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    • Institut für Biomechanik
    • Mr.  Professor  Peter  Augat 
    • Professor-Küntscher-Str. 8
    • 82418  Murnau
    • Germany
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    • Koordinationsstelle klinische Studien
    • Ms.  Dr. med.  Silke  Keiser 
    • Professor-Küntscher-Str. 8
    • 82418  Murnau
    • Germany
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    • Institut für Biomechanik / Ganganalyse
    • Ms.  Dr.  Isabella  Klöpfer-Krämer 
    • Professor-Küntscher-Str. 8
    • 82418  Murnau
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche gesetzliche Unfallversicherung DGUV
    • Alte Heerstr. 111
    • 53757  St. Augustin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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