Trial document




drksid header

  DRKS00017064

Trial Description

start of 1:1-Block title

Title

Minimally invasive spinopelvic stabilization in pelvic fractures type C to AO / OTA and type IV to FFP by internal fixator

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

Pelvic fractures are a rare injury, but show a significant increase over the last two decades. This is mainly due to the demographic development and the increased occurrence of pelvic fractures in the elderly. A look at the data of the German Pelvic Register (DGU®) shows that 68% of pelvic fractures are in patients older than 65 years.
One form of pelvic ring injury occurs mainly between the age of 20 and 30 years. These are mainly caused by high-displacement traumas (often traffic accidents and especially motorcycle accidents) and falls from high altitudes. These are often accompanied by serious accompanying injuries. A second age peak is found in the seventh decade of life and is mainly associated with osteoporosis and thus occurs even in low-energy trauma.
Due to the rare injury of the severe instal pelvic injury the experience in dealing with this inhomogeneous type of injury is also limited in large TraumaCentres®. Various surgical procedures are described, but ultimately no favored procedure can be highlighted.
After minimal invasiveness in stabilizing spine and pelvic surgery has become standard, we believe that spinopelvic support should also be used.
It is unclear whether a uniform osteosynthesis procedure can be used for both the traumatic pelvic fracture and osteoporotic pelvic fractures, thus making the decision to the treating surgeon

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

Brief Summary in Scientific Language

The incidence of pelvic fractures is low (0.3-8%) but has increased significantly over the last two decades. This is mainly due to the demographic development and the increased occurrence of pelvic fractures in the elderly. A look at the data of the German Pelvic Register (DGU®) shows that 68% of pelvic fractures are in patients older than 65 years.
One form of pelvic ring injury occurs mainly between the age of 20 and 30 years. These are mainly caused by high-displacement traumas (often traffic accidents and especially motorcycle accidents) and falls from high altitudes. These are often accompanied by serious accompanying injuries. A second age peak is found in the seventh decade of life and is mainly associated with osteoporosis and thus occurs even in low-energy trauma.
The classification is based, among other things, on the AO classification in type A (stable pelvic fracture, therefore often no surgical intervention needed), type B (rotationally unstable pelvic fractures) and type C (rotational and vertical unstable pelvic fractures). On the other hand, the classification according to Rommen's FFP (fragility fractures of the pelvis) types I to IV is suitable as a classification for the above-mentioned insufficiency fractures
Due to the absolutely low incidence, however, experience in dealing with this inhomogeneous type of injury is also limited in large TraumaCentres®. The pelvic fractures type C according to AO / OTA and the fragility fractures of the pelvic ring (FFP) of type IV according to Rommens and Hoffmann represent a special challenge, as they represent a high degree of instability. Definitive care of the unstable situation is important for pain control, early mobilization and the prevention of chronic instability or deformity.
The selection regarding the osteosynthesis in pelvic fractures type C or FFP type IV are described in many ways, but ultimately no favored method can be highlighted. After minimal invasiveness in stabilizing spine and pelvic surgery has become standard, we believe that spinopelvic support should also be used.
It is unclear whether a uniform osteosynthesis procedure can be used for both the Type C pelvic fracture and Type IV FFP, thus giving the treating surgeon the choice

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

  •   DRKS00017064
  •   2019/04/02
  •   [---]*
  •   yes
  •   Approved
  •   58/19, Ethik-Kommission der Universität Ulm
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

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

Interventions/Observational Groups

  •   Pelvic fractures type C, operative care, outcome
  •   osteoporotic Pelvic fractures type IV, operative care, outcome
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   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

The aim of our study is to present a uniform minimally invasive spinopelvic osteosynthesis method in pelvic fractures of type C or FFP type IV of a total of 19 patients and to compare them with the results of the literature.
Postoperatively applied imaging techniques (X-ray / CT)

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

Secondary Outcome

- Therapy method: spinopelvic support, minimally invasive
a) surgery time
b) Blood loss
c) postoperative infection
d) Screw misplacement and postoperative loosening
e) Reposition result according to Matta

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
  •   2019/04/01
  •   19
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

Pelvic fractures type C to AO / OTA and type IV to FFP

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

Exclusion Criteria

lack of imaging

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Bundeswehrkrankenhaus UlmAbteilung Orthopädie und Unfallchirurgie
    • Mr.  Prof.  Benedikt  Friemert 
    • Oberer Eselsberg 40
    • 89081  Ulm
    • 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
    • Bundeswehrkrankenhaus Ulm
    • Ms.  Dr  Patricia  Lang 
    • Oberer Eselsberg 40
    • 89081  Ulm
    • 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
    • Bundeswehrkrankenhaus Ulm
    • Mr.  Dr.  Hans-Joachim  Riesner 
    • Oberer Eselsberg 40
    • 89081  Ulm
    • 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
    • Bundeswehrkrankenhaus UlmAbteilung Orthopädie und Unfallchirurgie
    • Mr.  Prof.  Benedikt  Friemert 
    • Oberer Eselsberg 40
    • 89081  Ulm
    • 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.