Trial document





This trial has been registered retrospectively.
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  DRKS00016145

Trial Description

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Title

Modified candy package technique vs cerclage technique for the refixation of the lesser trochanteric fragment in intertrochanteric femoral fractures. A biomechanical comparison of 10 specimens.

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Trial Acronym

/

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URL of the Trial

http:///

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Brief Summary in Lay Language

Proximal femoral fractures often occur in the area of the trochanteric region they are called intertrochanteric fractures in this particular case. Due to the topographic location nearby the hip joint the treath of necrosis of the femoral head is given and as a consequence the operative fixation is indicated. One of the standard fixation strategies consists of an intramedullary nailing procedure with antirotational screw. In one of the particular cases of an intertrochanteric fracture the dislocation of the lesser trochanter can be noticed caused by the action of the musculus iliopsoas. One of the standard fixation strategies consists of wiring using a steel cerclage. The aim of the study was to compare the conventional one point fixation technique versus a newly introduced two point fixation technique. An intertrochanteric fracture was set in each of 10 human femora including the separation of the lesser trochanter. In a next step the stabilization of the fracture with an intramedullary nail was performed and - depending on the allocation to one of two groups - wiring of the lesser trochanter with either an one or a two point fixation method was performed. In a final step the action of the musculus iliopsoas was simulated with a cable pulley and the particular refixation technique was tested concerning its resistance against the axial force.

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Brief Summary in Scientific Language

proximal femoral fractures which intertrochanteric fractures belong to make up a major part of osseous injuries of the elder human population. In the middle European area these injuries make up a praevalence of 1,3% in the group of persons >85 years. The common mechanism of occurrence is a fall from low height or a sudden change of movement direction in the area of the particular hip. The isolated avulsion of the lesser trochanter shows an amount of 1,8% in the group of younger persons. Depending on the morphology of the fracture the division is performed in analogy to the AO classification into 3 main entities: simple intertrochanteric, intertrochnateric including the avulsion of the lesser trochanter and reversed intertrochanteric. Beside the common refixation technique performed with a single cerclage an alternative technique named "candy package technique" is described. This newly introduced technique was performed in a modified manner, the difference to the conventional method results from the possibility of a two point fixation of the particular lesser trochanter. In the course of this project an axial traction setup was established, the two fixation methods were compared concerning the pull out resistance of the particular lesser trochanter. For this purpose two groups à 5 femora were defined. In each of the specimens an identical fracture was crafted by the use of a saw guide. Next the fixation via intramedullary nailing (PFNA, Depuy/Synthes) was performed. Depending on the allocation to the particular group wiring of the lesser trochanteric fragment with either single or candy package cerclage was performed. In further consequence the femora were tested under axial traction, the setup was designed to simulate the action force of the musculus iliopsoas in the situation of 45° flexion in the hip joint. The main parameter consisted of the traction resistance of the particular refixation method measured in Newton and the dislocation behaviour of the lesser trochanteric fragment as side parameter.

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Organizational Data

  •   DRKS00016145
  •   2019/01/10
  •   [---]*
  •   yes
  •   Approved
  •   118/18, Ethik-Kommission der Universität Ulm
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Secondary IDs

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

  •   intertrochanteric femoral fracture AO 31-A.2
  •   S72.10 -  [generalization S72.1: Pertrochanteric fracture]
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Interventions/Observational Groups

  •   candy group/5 fresh frozen human Femora, intertrochanteric 3 part fracture - The basic osteosynthesis of the femoral shaft is performed with an intramedullary nailing procedure (PFN A, DePuy/Synthes), the refixation of the lesser trochanteric fragment is performed with the 2 point cerclage technique "candy package". In the next step the stability of the particular fragment fixation is tested in the manner of an axial traction setup simulating the action of the musculus iliopsoas.
  •   cable group/5 fresh frozen human Femora, intertrochanteric 3 part fracture - The basic osteosynthesis of the femoral shaft is performed with an intramedullary nailing procedure (PFN A, DePuy/Synthes), the refixation of the lesser trochanteric fragment is performed with the 1 point cerclage technique. In the next step the stability of the particular fragment fixation is tested in the manner of an axial traction setup simulating the action of the musculus iliopsoas.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

mechanical failure of the lesser trochanter refixation in the course of the traction test

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Secondary Outcome

Reaching the maximum traction force of the loading cell

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/08/01
  •   10
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

normal anatomy in the area of the proximal femur

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Exclusion Criteria

significant aberration of the normal anatomy in the area of the proximal femur

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Addresses

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    • Universitätsklinikum Ulm, Kliniken am oberen Eselsberg
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
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    • Universitätsklinikum UlmZentrum für ChirurgieKlinik für Unfall-, Hand-, Plastische und Wiederherstellungschirurgie
    • Mr.  Dr. med. Dr. med. univ.  Clemens  Schopper 
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
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    • Universitätsklinikum UlmZentrum für ChirurgieKlinik für Unfall-, Hand-, Plastische und Wiederherstellungschirurgie
    • Mr.  Dr. med. Dr. med. univ.  Clemens  Schopper 
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
    end of 1:1-Block address scientific-contact
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    end of 1:1-Block address contact scientific-contact
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    • Universitätsklinikum UlmZentrum für ChirurgieKlinik für Unfall-, Hand-, Plastische und Wiederherstellungschirurgie
    • Mr.  Dr. med. Dr. med. univ.  Clemens  Schopper 
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
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    end of 1:1-Block address contact public-contact
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Sources of Monetary or Material Support

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    • Deutsche Arthrosestiftung e V
    • Kopernikusallee 56
    • 75175  Pforzheim
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2018/08/16
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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.