Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000488

Trial Description

start of 1:1-Block title

Title

Functional long term results of pelvic and acetabular fractures: Comparison of treatment methods and outcome with special consideration
of fracture morphology and operative approach

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

Aim of the study is the follow-up of patients with pelvic or acetabular fracture treated at the Dep. of Orthopaedic Surgery at the University of Freiburg Medical School.
It is known that timely and anatomical fracture consolidation in case of acetabular and pelvic fractures does not always correlate with pain perception and life quality. Therefore, the question is going to be answered which factors play a possible role in influencing the clinical outcome. The following parameters will be assessed in this study:
- accompanying injuries (especially of the urinary and genital tract)
- degree of instability of pelvic fractures
- treatment strategy (operative(non-operative)
- initial dislocation and quality of reduction.

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

Brief Summary in Scientific Language

Aim of the study is the follow-up of patients with pelvic or acetabular fracture treated at the Dep. of Orthopaedic Surgery at the University of Freiburg Medical School. The data are part of a multicenter register that was introduced by the pelvic injury work group of the German Society of Traumatology (Deutsche Gesellschaft fuer Unfallchirurgie, DGU) and the German section of AO International in 1991. The 23 contributing hospitals are Level I trauma centres. The data are collected online using the services of Orthoglobe® (Institute for Evaluative Research in Orthopaedic Surgery (MEM-CED), University of Berne, Switzerland), the used online portal contains a validated standardized international documentation system for clinical, radiological, epidemiological, and implant data. About 50-70 patients are treated at our Level-I-trauma center every year. Considering a study duration of 10 years inclusion of 500-700 patients is planed for this study. The concept of the study as a follow-up of patients that are documented within a multicenter register includes the possibility for a comparison with results of other study centers based on the same study protocol. It is known that timely and anatomical fracture consolidation in case of acetabular and pelvic fractures does not always correlate with pain perception and life quality. Therefore, the question is going to be answered which factors play a possible role in influencing the clinical outcome. The following parameters will be assessed in this study:
- accompanying injuries (especially of the urinary and genital tract)
These injuries define the so call 'complex pelvic trauma', which was identified as a risk factor for a very high mortality.
- degree of instability of pelvic fractures (classification according to Tile and OTA)
- treatment strategy (operative(non-operative)
The frequency of operative treatment has risen in the last years, but the influence on clinical outcome still remains unclear.
- initial dislocation and quality of reduction.

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

  •   DRKS00000488
  •   2010/07/14
  •   [---]*
  •   yes
  •   Approved
  •   89/09, Ethik-Kommission der Albert-Ludwig-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1116-0109 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   S32.83 -  [generalization S32.8: Fracture of other and unspecified parts of lumbar spine and pelvis]
  •   S32.4 -  Fracture of acetabulum
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  • [---]*
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prognosis
  •   Other
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Evaluation of results following pelvic and acetabular fractures is meausured by the following scores:
Merle d´Aubigne (for pain perception)
SF-12 and EuroQol EQ-5D (for life quality). These scores are planed to be evaluated after 1 year in case of pelvic and after 2 years in case of acetabular fractures.

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

Secondary Outcome

Evaluation of results following pelvic and acetabular fractures is meausured by the following scores:
Harris-Hip-Score (hip function)
WOMAC Arthrosis index (development of coxarthrosis (only in case of acetabular fractures)
BFLUTS for evaluation of incontinence (only in case of pelvic fractures and women)
BSFI for evaluation of sexual function ( (only in case of pelvic fractures and men)
These scores are planed to be evaluated after 1 year in case of pelvic and after 2 years in case of acetabular fractures.

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

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2009/04/30
  •   500
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

Presence of pelvic or acetabular fracture
Necessity of in-patient treatment

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

Exclusion Criteria

denial of participation 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
    • Universitätsklinik Freiburg Dep. Orthopädie und Traumatologie
    • Mr.  Prof. Dr.   Norbert P.  Südkamp 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • 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
    • Universitätsklinik Freiburg Dep. Orthopädie und Traumatologie
    • Mr.  PD Dr. med.  Hagen  Schmal 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • 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
    • Universitätsklinik Freiburg Dep. Orthopädie und Traumatologie
    • Mr.  PD Dr. med.  Hagen  Schmal 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • 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
    • Universitätsklinik Freiburg Dep. Orthopädie und Traumatologie
    • Mr.  Prof. Dr. med.  Norbert P.  Südkamp 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • 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.