Trial document




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  DRKS00013562

Trial Description

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Title

A prospective randomized moncenter trial comparing the clinical, functional and psychosocial outcome after treatment of syndesmosis ruptures with a static syndesmotic screw fixation or TightRope.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

The accuracy of syndesmosis reduction is essential when treating acute ankle fracture accompanied by syndesomis ruptures. Malreduction leads to an earlier osteoarthrosis in the ankle.
The aim of this study was to compare the long term clinical outcome of patients with syndesmosis ruptures, who were treated with static screw fixation or dynamic TightRope fixation.

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Organizational Data

  •   DRKS00013562
  •   2017/12/07
  •   [---]*
  •   yes
  •   Approved
  •   S-454/2017, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   S82.4 -  Fracture of fibula alone
  •   S82.8 -  Fractures of other parts of lower leg
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Interventions/Observational Groups

  •   Patients with syndesmosis rupture and implantation of static syndesmotic screw fiaxtion
  •   Patients with syndesmosis rupture and implantation of "Tight Rope"
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

postoperative outcome measurement with several questionnaires and x-rays after 6 weeks, 3, 6 and 12 months:

"Fragebogen zum Vergleich Stellschraube vs TightRope"
"SF-12"
"Score of Olerud and Molander"
"VAS visual pain scale"
"Foot and ankle outcome score"

Outcome measurement with MRI only 3 months postoperatively

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Secondary Outcome

postoperative measurement and comparison of the long term outcome in x-ray 6 weeks, 3, 6 and 12 months after implantation of screws or TightRope
additionally with an MRI 3 months postoperatively and as appropriate with gait analysis

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2017/12/07
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients of full age with a syndesmosis rupture

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Exclusion Criteria

younger than 18, approval disability, congenital deformity, missing approval, contraindication for MRI

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Addresses

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    • Zentrum für Orthopädie, Unfallchirurgie und Paraplegiologie
    • Mr.  Dr. med.  Julian  Doll 
    • Schlierbacher Landstrasse 200a
    • 69118  Heidelberg
    • Germany
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    • Universität Heidelberg, Zentrum für Orthopädie, Unfallchirurgie und Paraplegiologie
    • Mr.  PD Dr. med.  Christian Alexander  Fischer 
    • Schlierbacher Landstrasse 200a
    • 69118  Heidelberg
    • Germany
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    • Zentrum für Orthopädie, Unfallchirurgie und Paraplegiologie
    • Mr.  Dr. med.  Julian  Doll 
    • Schlierbacher Landstrasse 200a
    • 69118  Heidelberg
    • Germany
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    • Zentrum für Orthopädie, Unfallchirurgie und Paraplegiologie
    • Mr.  Dr. med.  Julian  Doll 
    • Schlierbacher Landstrasse 200a
    • 69118  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Zentrum für Orthopädie, Unfallchirurgie und Paraplegiologie
    • Mr.  Dr. med.  Julian  Doll 
    • Schlierbacher Landstrasse 200a
    • 69118  Heidelberg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.