Trial document




drksid header

  DRKS00012838

Trial Description

start of 1:1-Block title

Title

Clinical and radiological results after surgically treated ankle fracture type Weber B with and without injury to syndesmosis

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

Injuries of the upper ankle are frequent and this joint is one of the most frequently injured joints in sport. Ankle fractures account for 9% of all human fractures. The upper ankle is an important joint, which is the connection between the lower leg and the foot and contributes significantly to the painless movement and maneuverability of the human being. The injury of the external ankle is a frequent injury under the fractures of the upper ankle joint, which can be isolated, but can also occur in combination with the inner ankle and ankle bone. As a result of this injury it can occur in rare cases to a wear of the cartilage surfaces, also called arthrosis in different manifestation. There are few long-term data on the development of these arthroses and the involvement of adjected joints by the mechanical overload. In addition to a personal examination of the foot affected by X-ray examinations, a photodocumentation of both feet is performed. The radiographs are standard images of the upper ankle in 2 planes and of the foot under load.

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

Brief Summary in Scientific Language

The injury to the distal fibula is a frequent injury in the fractures of the upper ankle, which can be isolated, but can also occur in combination with the distal tibia and talus. In order to avoid posttraumatic damage, the maintenance / restoration of the bony anatomy, consisting of the internal ankle with the distal tibia, distal fibula and talus, is important. Operatively it is stabilized by a plate with or without stabilization of the anterior lower syndesmosis band. The clinical results of the operation of the isolated fibular fracture are determined by the ability to roll and walk in the upper ankle joint. Late complications include osteoarthritis and healing, which greatly reduce patients' quality of life.

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

Organizational Data

  •   DRKS00012838
  •   2017/09/14
  •   [---]*
  •   yes
  •   Approved
  •   7520, 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

  •   M19.17 -  [generalization M19.1: Post-traumatic arthrosis of other joints]
  •   S82.6 -  Fracture of lateral malleolus
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients after osteosynthesis with one-third tube plate and syndesmotic stabilization: In addition to a personal examination of the foot affected by X-ray examinations, a photodocumentation of both feet is performed. The radiographs are standard images of the upper ankle in 2 planes and of the foot under load. Follow up > 24 months.
  •   Patients after osteosynthesis with one-third tube plate without syndesmotic stabilization: In addition to a personal examination of the foot affected by X-ray examinations, a photodocumentation of both feet is performed. The radiographs are standard images of the upper ankle in 2 planes and of the foot under load. Follow up > 24 months.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

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

Primary Outcome

Posttraumatic osteoarthritis. Measured in clinical examination using the Kellgren score in radiographs.
AOFAS score. Raised by questionnaire. Parameter: pain, function, shoes, walking distance, surface, walk abnormality, axis.

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

Secondary Outcome

Arthrolysis of the upper ankle, the amputation of the leg or the death of the patient

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

  •   Actual
  •   2017/12/14
  •   300
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

Patients who are eligible for consent.
Isolated fractures of the external Weber-B type ankle fractures which were treated with a plate between 2006 and 2016.
Follow-up interval at least 24 months

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

Exclusion Criteria

Age <18 years at the time of the examination.
Dementia.
Re-osteosynthesis.
Multiple injuries.
Other osteosynthesis procedures as a one-third tube plate.

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik f. Unfallchirurgie, Sektion Obere Extremität, Fuß - und Rheumachirurgie
    • Mr.  Prof. Dr. med.  Ralph  Gaulke 
    • Carl-Neuberg-Str. 1
    • 30625  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
    • Klinik f. Unfallchirurgie, Sektion Obere Extremität, Fuß - und Rheumachirurgie
    • Mr.  Prof. Dr. med.  Ralph  Gaulke 
    • Carl-Neuberg-Str. 1
    • 30625  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
    • Klinik f. Unfallchirurgie, Sektion Obere Extremität, Fuß - und Rheumachirurgie
    • Mr.  Prof. Dr. med.  Ralph  Gaulke 
    • Carl-Neuberg-Str. 1
    • 30625  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
    • Else Kröner-Fresenius-Stiftung
    • Postfach 1852
    • 61288  Bad Homburg v.d.H
    • 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
  •   2018/07/31
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   In Vivo. 2019 Jan-Feb;33(1):255-261. doi: 10.21873/invivo.11469.
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.