Trial document




drksid header

  DRKS00004607

Trial Description

start of 1:1-Block title

Title

Prospective randomized clinical Trial analyzing the outcome of different preparation techniques of the Pronator Quadratus muscle during volar plating of distal radius fractures

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Within this trial two different preparation and recontructive techniques of the Pronator Quadratus muscle during volar plating of a distal radius fracture are compared.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Can a specific operation technique of the Pronator Quadratus Muscle during volar plating of a distal radius fracture reduce implant-associated irritations of the flexor tendons of the wrist? Are there differences between the used plates?

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004607
  •   2015/09/17
  •   [---]*
  •   yes
  •   Approved
  •   087 / 2011 BO1, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   S52.5 -  Fracture of lower end of radius
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   volar plating using transmuscular approach through the Pronator Quadratus muscle and following reconstruction with muscle suture
  •   volar plating after muscle-sparing dissection of the radial tendon of Pronator Quadratus muscle and following reconstruction
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

implant-associated irritations of the flexor tendons of the wrist
measured 6 weeks, 12 weeks, 6 month and 12 month postoperative by questionnaire (DASH-Score), measurement of mobility and sonography

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

sonographic measured thickness of Pronator Quadratus muscle
measurement 6 weeks, 12 weeks, 6 month and 12 month postoperative by ultrasound, recording of thickest point

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2015/12/31
  •   80
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   110   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Patients with a distal radius fracture (AO Classification 23 A2 - 23 C2) that are treated by volar plating using Synthes 2.4mm VA or Aptus 2.5mm plates

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

not capable of giving consent
bilateral fracture
other fracture on the same arm / shoulder / hand
refracture
neurologic desease ( radiculopathy , Plexus lesion , carpal tunnel syndrome , hemiparesis on affected side , systemic nerve or muscle disease )
Previous surgery on the wrist ( CTS )
external fixator

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • BG-Unfallklinik Tübingen
    • Mr.  PD Dr. med.  Atesch  Ateschrang 
    • Schnarrenbergstr. 95
    • 72076  Tübingen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • BG-Unfallklinik Tübingen
    • Mr.  Dr. med.  David  Wohland 
    • Schnarrenbergstr. 95
    • 72076  Tübingen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • BG-Unfallklinik Tübingen
    • Mr.  Dr. med.  David  Wohland 
    • Schnarrenbergstr. 95
    • 72076  Tübingen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • BG-Unfallklinik Tübingen
    • Mr.  PD Dr. med.  Atesch  Ateschrang 
    • Schnarrenbergstr. 95
    • 72076  Tübingen
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.