Trial document





This trial has been registered retrospectively.
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  DRKS00020550

Trial Description

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Title

Supplemental cerclage wiring in cephalomedullary nailing of trochanteric and subtrochanteric femoral fractures

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The operative management of thigh fractures requires, in addition to the correct selection of the suitable implant, the exact anatomical reduction. With these unstable fracture patterns, there is often an indication for the use of extra 'wires' (so called cerclage). Therefore, as part of a retrospective study of prospectively collected data over a period of five years (2014 to 2019), 260 consecutive patients with a diagnosis of thigh fracture were included and the frequency and outcome of the use of these cerclages was examined.

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Brief Summary in Scientific Language

The operative management of per- and subtrochanteric femoral fractures requires, in addition to the correct selection of the suitable implant, the exact anatomical reduction. With these unstable fracture patterns, there is often an indication for the use of auxillary cerclages to ensure reduction, increase of intrinsic stability and retention. Therefore, as part of a retrospective study of prospectively collected data over a period of five years (2014 to 2019), 260 consecutive patients with a diagnosis of a trochanteric and subtrochanteric fracture were included and the frequency of the use of auxillary cerclages as part of intramedullary nail osteosynthesis and the outcome was examined.

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

No

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00020550
  •   2020/01/30
  •   [---]*
  •   yes
  •   No approval required according to EC
  •   2019-170, Ethik-Kommission der Bayerischen Landesärztekammer
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Secondary IDs

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

  •   S72.1 -  Pertrochanteric fracture
  •   S72.2 -  Subtrochanteric fracture
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Interventions/Observational Groups

  •   Retrospektive Analysis from 2013 to 2019 Patients with cephalomedullary nailing of S72.1-S72.2 fractures without supplemental cerclage wiring
  •   Retrospektive Analysis from 2013 to 2019 Patients with cephalomedullary nailing of S72.1-S72.2 fractures with supplemental cerclage wiring
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Discharged from Hospital and complications

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Secondary Outcome

5-year-follow-up for consolidation and LEFS (Lower Extremity Functional Scale)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/07/05
  •   300
  •   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

AO/OTA A1 bis A3 fractures which were stabilized using cephalomedullary nailing with or without the use of additional cable cerclage wiring from 2013 to 2019

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Exclusion Criteria

Pathological fractures, periprosthetic fractures, and fractures treated with fracture prostheses or extramedullary fixation procedures were excluded from the study, as were patients younger than 18 years and patients who could not give their informed consent.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • BG Unfallklinik Murnau
    • Mr.  PD (PMU) Dr.med  Christian  von Rüden 
    • Prof. Küntscher-Straße 8
    • 82418  Murnau
    • Germany
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    • BG Unfallklinik Murnau
    • Mr.  PD (PMU) Dr.med  Christian  von Rüden 
    • Prof. Küntscher-Straße 8
    • 82418  Murnau
    • Germany
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    • BG Unfallklinik Murnau
    • Ms.  Dr.med  Julia  Rehme 
    • Prof.-Küntscher-Straße 8
    • 82418  Murnau
    • Germany
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Sources of Monetary or Material Support

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    • BG Unfallklinik Murnau
    • Mr.  PD (PMU) Dr.med  Christian  von Rüden 
    • Prof. Küntscher-Straße 8
    • 82418  Murnau
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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Trial Publications, Results and other Documents

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