Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00010294

Trial Description

start of 1:1-Block title

Title

Clinical results treating olecranon fractures with locked plating: comparing two implants

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

The Synthes 2,7/3,5mm VA-LCP-Olecranon plate is a standard locked plating implant in treating olecranon fractures with good clinical results. The Medartis olecranon double plate osteosynthesis is an alternative with an low implant profile. Due to the thin design a less number of skin irritations are expected without disadvantages in stability. Since there are no clinical results of this new implant, we compared these two implants in the clinical routine.

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

Brief Summary in Scientific Language

The treatment of olecranon fractures with the 2,7/3,5mm VA-LCP olecranon plate shows good first clinical result in small patient collectives. Clinical data about the Medartis olecranon plate are not yet available. Since the Medartis olecranon plate is much thinner than the VA-LCP olecranon plate, the comparison of those two implants is of particular interest in clinical practice. A less number of skin irritations are expected due to the thinner implant design without any disadvantages in stability.

The purpose of this study is to evaluate the clinical and functional results after the treatment of olecranon fractures with a locked plating system. Furthermore the functional results, subjective complaints as skin irritation and complications of the two implants are to be compared.

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

Organizational Data

  •   DRKS00010294
  •   2016/04/12
  •   [---]*
  •   yes
  •   Approved
  •   2612-2015, Ethikkommission der Medizinischen Hochschule Hannover
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

  •   S52.01 -  [generalization S52.0: Fracture of upper end of ulna]
  •   Fracture of the olecranon (upper edge of the ulna)
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Synthes 2,7/3,5mm VA-LCP olecranon plate
  •   Medartis olecranon double plate
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IV
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Within this retrospective study with a minimum follow-up of 1 year a clinical follow-up examination is performed. The functional result is evaluated due to the range of motion of the elbow, skin irritation due to an clinical examination and complications due to anamnesis and clinical record. Furhtermore the clinical result is objectified by the Mayo-Elbow-Performance-Score and Disabilities of the arm, shoulder and hand (DASH-Score)

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

Secondary Outcome

Within this follow-up examination a complication analyis is perfomed with an evaluation of revision surgeries. Additionally implant removals are analysed.

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

Recruitment

  •   Actual
  •   2015/08/19
  •   66
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

- Olecranon fracture treated with s locked plating implant (2,7/3,5mm VA-LCP Olekanon Plate Synthes or Medartis Olecranon double plate).
- Men and woman with an age of 18 years or older.
- Sufficient compliance for participate at this study.

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

Exclusion Criteria

- preexisting diseases or injuries, which affect the strengh of function of the elbow.
- an immunsupressive therapy, drug or alcohol consumption
- patients with an concomitant injury of the elbow (for example: Monteggia like leasion).

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Friederikenstift Hannover, Abteilung Unfall- und Wiederherstellungschirurgie
    • Mr.  Prof. Dr.  Helmut  Lill 
    • Humboldtstr. 5
    • 30169  Hannover
    • 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
    • Diakovere Friederikenstift
    • Mr.  Dr.  Alexander  Ellwein 
    • Humboldtstr. 5
    • 30169  Hannover
    • 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
    • Diakovere Friederikenstift
    • Mr.  Dr.  Alexander  Ellwein 
    • Humboldtstr. 5
    • 30169  Hannover
    • 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
    • DIAKOVERE Friederikenstift, Klinik für Orthopädie und Unfallchirurgie
    • Humboldtstr. 5
    • 30169  Hannover
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   0511-1290
    •   [---]*
    •   [---]*
    •   [---]*
    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
  •   2019/01/01
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.