Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00012836

Trial Description

start of 1:1-Block title

Title

Long-term results after non-operative and operative treatment of radial neck fractures in adults

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 isolated fracture of the radial neck is a rare injury in adults. Most of the available studies regarding the outcome of these fractures have combined results of radial neck and head fractures. Few studies have examined the results of isolated fractures. In our study we evaluate the clinical and radiological outcome of radial neck fractures following non-operative and operative treatment.

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

Brief Summary in Scientific Language

Fractures of the proximal radius can affect the radial head as well as the radial neck. While in children radial neck fractures are common, this is a rare entity in adults. Nonetheless, these fractures can cause severe impairments of the function of the elbow regarding range of motion and pain. In this study, several clinical outcome scores as well as radiological parameters are evaluated to compare operative vs. non-operative treatment in relation to the initial radiologic findings.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00012836
  •   2017/08/07
  •   [---]*
  •   yes
  •   Approved
  •   837.261.15 (10029), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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

  •   S52.12 -  [generalization S52.1: Fracture of upper end of radius]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Operatively treated patients - parameters consist of radiological results based on the quality of reduction postoperatively and clinical results based on the follow up examination (see above for scores), at least 2 years after the injury
  •   Non-operatively treated patients - parameters consist of radiological results based on the changes in fracture dislocation in follow-up x-rays and clinical results based on the follow-up examination (see above for scores), at least 2 years after the injury
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
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Clinical results: Scores MEPS (Mayo Elbow Performance Score) and DASH (Disabilities of the Arm, Shoulder and Hand) at the follow-up examination (at least 2 years after the injury)

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

Secondary Outcome

Radiological results: fracture dislocation in follow-up films

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
  •   2015/09/01
  •   34
  •   Monocenter 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

- fracture of the radial head without other relevant injuries of the elbow that were treated between September 2000 and August 2013
- minimal follow-up of two years
- minimum age 18 years

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

Exclusion Criteria

- illnesses with impairment of bone quality or joint movement
- refused or not able to take part in the study

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • BG Klinik Ludwigshafen
    • Ludwig-Guttmann-Str. 13
    • 67071  Ludwigshafen
    • 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 Klinik Ludwigshafen
    • Mr.  Dr.  Holger  Keil 
    • Ludwig-Guttmann-Str. 13
    • 67071  Ludwigshafen
    • 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 Klinik Ludwigshafen
    • Mr.  Dr.  Holger  Keil 
    • Ludwig-Guttmann-Str. 13
    • 67071  Ludwigshafen
    • 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 Klinik Ludwigshafen
    • Ludwig-Guttmann-Str. 13
    • 67071  Ludwigshafen
    • 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
  •   2016/04/01
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.