Trial document




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  DRKS00004647

Trial Description

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Title

Comparison of multidetector CT and flat-panel CT for diagnosis of distal radius fractures.

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Trial Acronym

MAFRA (comparison of Multidetector ct And Flat-panel ct for diagnosis of distal RAdius fractures)

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URL of the Trial

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Brief Summary in Lay Language

The digital volume tomography (DVT) is a tomographic imaging procedure in Radiology that employs Xrays in a manner similar to that of multi-detector computed tomography (MDCT). We are interested in whether the DVT is not inferior to the CT in the diagnosis of distal radius fractures.

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Brief Summary in Scientific Language

The DVT, like the CT, is a procedure that allows superposition free tomographic images of bone structures. The DVT is already widespread as a method of craniofacial examination. Here phantom measurements have demonstrated that the radiation dose of DVT examinations can be lower than that of comparable standard CT protocols (Chau & Fung, 2009; Silva et al, 2008; Suomalainen et al, 2009). However, due to the technology, the DVT examination of 18 seconds is longer than the CT examination, which makes it more prone to motion artifacts.
We now wish to evaluate whether the DVT is not significantly worse than the CT in the diagnosis of distal radius fractures. It has been established that the CT is much better than conventional X-ray imaging in the diagnosis of distal radius fractures (Cole et al, 1997; Dahlen et al, 2004). The guidelines of the German Society of Trauma Surgery, therefore, recommend the CT as an optional diagnostic for distal radius fractures (Dresing & Stürmer, 2008).
Our study will include fully-oriented, adult patients with indication for a CT examination of a distal radius fracture. With informed consent, these patients will be randomized into two groups. The randomization will take place with numbered, sealed envelopes. Group A will receive a CT examination, as it is the standard procedure. Group B will be examined in the DVT.

Chau AC, Fung K (2009) Comparison of radiation dose for implant imaging using conventional spiral
tomography, computed tomography, and cone-beam computed tomography. Oral Surg Oral Med Oral Pathol
Oral Radiol Endod 107(4): 559-565
Cole RJ, Bindra RR, Evanoff BA, Gilula LA, Yamaguchi K, Gelberman RH (1997) Radiographic evaluation of
osseous displacement following intra-articular fractures of the distal radius: reliability of plain radiography
versus computed tomography. J Hand Surg Am 22(5): 792-800
Dahlen HC, Franck WM, Sabauri G, Amlang M, Zwipp H (2004) [Incorrect classification of extra-articular
distal radius fractures by conventional X-rays. Comparison between biplanar radiologic diagnostics and CT
assessment of fracture morphology]. Unfallchirurg 107(6): 491-498
Dresing K, Stürmer M (2008) Distale Radiusfraktur. Leitlinien der Deutschen Gesellschaft für Unfallchirurgie.
Silva MA, Wolf U, Heinicke F, Bumann A, Visser H, Hirsch E (2008) Cone-beam computed tomography for
routine orthodontic treatment planning: a radiation dose evaluation. Am J Orthod Dentofacial Orthop 133(5):
640 e641-645
Suomalainen A, Kiljunen T, Kaser Y, Peltola J, Kortesniemi M (2009) Dosimetry and image quality of four
dental cone beam computed tomography scanners compared with multislice computed tomography scanners.
Dentomaxillofac Radiol 38(6): 367-378

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Organizational Data

  •   DRKS00004647
  •   2013/02/22
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  •   yes
  •   Approved
  •   424/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1139-2340 
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Health Condition or Problem studied

  •   S52.5 -  Fracture of lower end of radius
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Interventions/Observational Groups

  •   Patients with a distal radius fracture and indication for a CT exam are examined in the DVT. Afterwards the anonymized images are evaluated.
  •   Patients with a distal radius fracture and indication for a CT exam are examined in the CT. Afterwards the anonymized images are evaluated.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Diagnostic
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Specificity and sensitivity of CT and DVT for fracture, AO type of fracture, joint involvement,
areas of bone impression, intra-articular fragments and position of the fracture. Semi-quantitative assessment of image quality concerning AO fracture classification, evaluability of fracture lines,
cortical bone, cancellous bone, joint surfaces, soft tissue and presence of artifacts. After the examination of the patients the anonymized images are evaluated.

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Secondary Outcome

Complications of the examinations. Duration of the study. This information will be recorded in a questionnaire directly after the examination.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/03/01
  •   126
  •   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

Grown-up, fully oriented patients that need a CT examination for evaluation of a fracture of the distal
radius.

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Exclusion Criteria

Minors. Not fully oriented. No CT necessary. Dependency of the study leaders.

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Addresses

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    • Universitätsklinik Freiburg
    • Hugstetterstraße 49
    • 79095  Freiburg
    • Germany
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    • Department für Orthopädie und Traumatologie Uniklinik Freiburg
    • Mr.  Doktor  Kilian  Reising 
    • Hugstetter Straße 49
    • 79095  Freiburg
    • Germany
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    • Radiologie Uniklinik Freiburg
    • Mr.  Doktor  Jakob  Neubauer 
    • Hugstetter Straße 49
    • 79095  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik Freiburg
    • Hugstetter Straße 49
    • 79095  Freiburg
    • 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.