Trial document




This trial has been registered retrospectively.
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  DRKS00013275

Trial Description

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Title

Retrospective analysis for treatment of proximal tibial fractures with a complete metaphyseal component in two centers with different distinct strategies: Open reduction and internal fixation (ORIF) and Ilizarov frame (Odense, Denmark) versus ORIF and locking plates (Freiburg, Germany)

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Trial Acronym

ProTibExPla

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URL of the Trial

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Brief Summary in Lay Language

The concurrent presence of a joint and a metaphyseal component is a typical biomechanical characteristic of proximal tibial fractures. Whereas the articular surface requires anatomical reduction and internal fixation providing absolute stability, the metaphysis is usually fixed with implants offering relative stability considering the local biological requirements. This can be done using external or internal fixation. The study aimes to compare both methods.

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Brief Summary in Scientific Language

The concurrent presence of a joint and a metaphyseal component is a typical biomechanical characteristic of proximal tibial fractures. Whereas the articular surface requires anatomical reduction and internal fixation providing absolute stability, the metaphysis is usually fixed with implants offering relative stability considering the local biological requirements. Locking plates, which were introduced in the 90ies [1], allow an effective treatment addressing both parts. A more traditional approach is the combination of lag screws for joint reconstruction with an Ilizarov frame stabilizing the metaphysis. Clinical results were reported for both treatment standards [2, 3], however, comparing studies are lacking. Recently, a systematic review evaluated both principals based on the published cohort studies [4]. Although the paper makes a differentiated analysis available, there are obvious difficulties e.g. report the included studies only case series and do not compare, and inclusion criteria or outcome parameter do not match each other. Overall, the current literature is limited to an expert opinion level. In conclusion, there is a need for comparative studies. A major problem in orthopedic surgery is that the procedure under investigation needs to be carried out with a specific competence. Therefore, multicenter study designs with a ‘one arm – one center’ - design experienced a growing popularity, because they allow that a specific operation is performed repeatedly and with high quality in one of the participating hospitals [5]. As a first step, a retrospective evaluation of patients treated differently in two large hospitals of comparable competence, spectrum and size facilitates a direct comparison of tibial metaphyseal stabilization methods. Efficacy of bony consolidation is a suitable primary endpoint, because it is both important and well documented. Our hypothesis is that the treatment of proximal tibial fractures with a complete metaphyseal component is equally efficient comparing stabilization using an Ilizarov frame with locking plates.

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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00013275
  •   2017/11/10
  •   [---]*
  •   yes
  •   Approved
  •   582/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1204-6367 
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Health Condition or Problem studied

  •   S82.1 -  Fracture of upper end of tibia
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Interventions/Observational Groups

  •   retrospective registration of proximal tibia fractures with complete metaphyseal component (Schatzker types V/VI, OTA/AO A2/3, C1-3) treated with Ilizarov frame
  •   retrospective registration of proximal tibia fractures with complete metaphyseal component (Schatzker types V/VI, OTA/AO A2/3, C1-3) treated with locking plates
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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
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

bony consolidation after 6 months evaluated by X-rays and clinical weight bearing

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Secondary Outcome

complications

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Countries of Recruitment

  •   Germany
  •   Denmark
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/07/18
  •   200
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

Inclusion criteria were: patients with an AO 41 A2, A3 or C1-C3 fracture, who were treated either with external fixation using the Ilizarov wire frame or open reduction and internal fixation using locking plates between the 1. January 2009 and the 31. December 2015.

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Exclusion Criteria

Exclusion criteria were: patients younger than 15 years of age at the time of the fracture or with open growth plates; patients with definitive operative fixation of the fracture more than 3 weeks after trauma; patients with pathological fractures (including osteoporotic fractures).

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Addresses

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    • Universitätsklinik Freiburg, Klinik für Orthopädie und Unfallchirurgie
    • Mr.  PD  Kaywan  Izadpanah 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • University Hospital Odense, Department of Orthopaedics and Traumatology
    • Mr.  Prof.  Hagen  Schmal 
    • Sdr. Boulevard 29
    • 5000  Odense C
    • Denmark
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    • Universitätsklinik Freiburg, Klinik für Orthopädie und Unfallchirurgie
    • Mr.  PD  Kaywan  Izadpanah 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinik Freiburg, Klinik für Orthopädie und Unfallchirurgie
    • Mr.  PD  Kaywan  Izadpanah 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/09/30
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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.