Trial document




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  DRKS00005356

Trial Description

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Title

a CompArative evaluation of Image quality of Mdct and fpct in the diAgNostic of the wrist.

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Trial Acronym

CAIMAN

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URL of the Trial

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Brief Summary in Lay Language

For the evaluation of bony pathologies of the wrist conventional radiography is still used in the first line. However, a final assessment of the tubby and very differently shaped carpal bones is often not possible in this 2D technique. A sectional imaging technique is used if the x-ray does not help. Usually, a multi - detector computed tomography (MDCT) scan is performed. Our new flat-panel detector CT (digital volume tomogramm/ DVT) is as well capable of sectional wrist imaging with the described advantage of higher spatial resolution and better possibilities of shielding the patient’s radiation sensitive organs during the investigation. However, the investigation takes longer than in the MDCT, which increases the likelihood of motion artifacts. To compare the image quality of both existing methods, the testing is performed with the same radiation dose. As there is no prospective data in the literature comparing these two methods we hope to generate suchlike.

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Brief Summary in Scientific Language

Approximatly 10 % of wrist injuries lead to carpal fractures with 60 % of them affecting the scaphoid bone which hereby represents the most common carpal fracture. ( Schunk et al , 1989). With decreasing frequency carpal fractures occur in the triquetrum and as combination injuries (Schmitt / Lanz , 2004). Conventional radiography is still performed first for initial assessment of wrist pain after trauma. For cases where clinical suspicion is not supported by findings in plain radiographs or further information is needed sectional imaging techniques are required as only 3D methods can guarantee a reliable diagnostic assessment of the wrist. Thus, procrastination of diagnosis and favoring of severe complications especially of the scaphoid fracture can be avoided (Krimmer et al., 2000).
Recently a CT scanner with flat panel detector has been developed as extremity scanner and as such represents a new imaging technique for hand and wrist diagnostics which is available in our institution. For this flat - detector CT (digital Volumentomgraphie/ DVT) the advantage of higher spatial resolution compared to the normal multidetector CT is described . Additionally specific scanner design for extremity imaging may lead to the possibility of better shielding the patient’s radiosensitive organs during the examination.
Scans in the DVT take 18 seconds. CT scans are much faster with an imaging time of about 0.5 second. Thus, the DVT is more susceptible to motion artifacts.
The DVT is commonly used for scans of the facial skeleton ( Scarfe and Farman , 2008). However, there is no prospective data on the comparison of multidetector CT and DVT for imaging of the carpus. With this study we want to provide the evidence that the image quality of the DVT is similar to that of the multidetector CT in the imaging of the carpus.


Coblenz G, Christopoulos G, Frohner S, Kalb KH, Schmitt R (2006) [Scaphoid fracture and nonunion: current status of radiological diagnostics]. Radiologe 46(8): 664, 666-676

Krimmer H, Schmitt R, Herbert T (2000) [Scaphoid fractures--diagnosis, classification and therapy]. Unfallchirurg 103(10): 812-819

Scarfe WC, Farman AG (2008) [What is cone-beam CT and how does it work? ] Dent Clin North Am 52(4): 707-730

Schmitt R, Lanz U (2004) [Bildgebende Diagnostik der Hand]. Georg Thieme Verlag

Schunk K, Weber W, Strunk H, Regentrop H, Thelen R, Schild H (1989) [Traumatology and diagnosis of scaphoid fracture]. Radiologe 29(2): 61-67

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Organizational Data

  •   DRKS00005356
  •   2013/11/06
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  •   yes
  •   Approved
  •   245/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1149-8373 
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Health Condition or Problem studied

  •   bony pathologies of the wrist
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Interventions/Observational Groups

  •   Patients with indication for a CT scan of the wrist/ hand are examined in the DVT. This is followed by analysis of the anonymized image data sets.
  •   Patients with indication for a CT scan of the wrist/ hand are examined in the multidetector CT. This is followed by analysis of the anonymized image data sets.
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Characteristics

  •   Non-interventional
  •   Other
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Diagnostic
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Semi quantitative comparison of image quality with assessment of cortical bone, cancellous bone, joint surfaces, soft tissue and artifacts. Analysis is performed with anonymized data.

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Secondary Outcome

Complications resulting from the examinations and examination length are documented by the technician.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/03/03
  •   100
  •   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

Adults capable of written informed consent with indication for a CT scan of the wrist

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Exclusion Criteria

Pregnant women, minors, adults incapable of written informed consent and patients with severe associated injuries (polytraumatised)

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Addresses

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    • Universitätsklinik Freiburg
    • Hugstetterstraße 49
    • 79095  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg
    • Mr.  Dr.  Jakob  Neubauer 
    • Hugstetterstraße 49
    • 79095  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg
    • Mr.  Dr.  Sebastian  Goerke 
    • Hugstetterstraße 49
    • 79095  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinikum Freiburg Klinik für RadiologieKlinik für Plastische und Handchirurgie
    • Hugstetterstr. 49
    • 79095  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/06/12
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Trial Publications, Results and other Documents

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