Trial document




drksid header

  DRKS00008870

Trial Description

start of 1:1-Block title

Title

Influence of pulsed electromagnetic fields on bone healing after high tibial osteotomy

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

To complete our information basis with clinical outcomes there are new concepts in the postoperative care available. One is the external electromagnetic therapy, which we offer as a portable device for home use to patients. It sends temporarily electromagnetic fields to support bone healing and is placed over the surgical field postopertively.
The device should be worn every day for 7 minutes. This treatment extends over a period of 30 days. Participating patients are divided randomly into two groups: control and placebo group. In the control group, an electromagnetic field is actually sent, in the placebo group not. This is not apparent to the respective user neither to the treating physician. Subsequently the results of the above mentioned treatment is controlled based on conventional radiographs and investigating various serum markers in the blood. In addition, operation bone wedges are also electromagnetically treated in vitro and compared with our clinical data.

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

Brief Summary in Scientific Language

The question is if there is a benefit by the use of PEMF therapy concerning bone fractures. The patients should apply the device for 7 minutes daily (eg in the morning ). This application extends over a period of 30 days. It should be clarified if there are differences between the experimental and the control group in terms of osseous consolidation and regarding blood serum markers such as alkaline phosphatase. These results should be compared with the results of in vitro testing of the osseous wedges from the operation. The clinical results are analyzed by conventional radiographs.

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

Organizational Data

  •   DRKS00008870
  •   2015/07/16
  •   [---]*
  •   yes
  •   Approved
  •   337/2015BO1, 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

  •   bone healing after gigh tibial osteotomy
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients after tibial osteotomy use a device for external electromagnetic therapy over the operated area for 30 days. The device will be used ofr 7 minutes daily.
    Name of device:
    Somagen Master, Sachtleben GmbH
  •   Placebo group: the same as group 1, but the device does not create an electromagnetic field
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

30 and 90 days after operation - Evaluation of osseous consolidation with the use of xray

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

Secondary Outcome

5 days after operation - increase of serous markers compared to the praeoperative control blood sample and correlation with osseous consolidation

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

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

Recruitment

  •   Planned
  •   2015/08/03
  •   75
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   45   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

open wedge osteotomy, study commitment

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

Exclusion Criteria

Diabetes, hinge fracture, constant use of medication with influence towards osseous metabolism

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Siegfried Weller Institut Tübingen
    • Mr.  Prof. Dr.  Andreas  Nüssler 
    • Schnarrenbergstraße 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.  Patrick  Ziegler 
    • Schnarrenbergstraße 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.  Patrick  Ziegler 
    • Schnarrenbergstraße 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
    • Sachtleben GmbH
    • Stratenbarg 27
    • 22393  Hamburg
    • 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 complete, follow-up complete
  •   1018/07/02
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.