Trial document





This trial has been registered retrospectively.
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  DRKS00012833

Trial Description

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Title

Advanced Microperfusion Assessed Non-union Diagnostics with Ultrasound

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Trial Acronym

AMANDUS

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URL of the Trial

https://www.klinikum.uni-heidelberg.de/Muskuloskelettale-Bildgebung.139919.0.html

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Brief Summary in Lay Language

Delayed healing or non-union is a significant complication in the treatment of long-bone fractures. Reasons for an absence of healing include a lack of biomechanical stability, impaired vitality and perfusion of the fracture and bacterial infection. The cause for a non-union defines its treatment, e.g. bone cement containing antibiotic is implanted temporarily in case of infection.
To date, infected non-unions can not safely be identified preoperatively, but only on the basis of microbiological testing of tissue samples acquired during surgery.
In this study, contrast-enhanced ultrasound (CEUS) and magnetic resonance imaging (DCE-MRI) are evaluated to determine their quality to predict infection preoperatively. A contrast agent is applied intravenously while the non-union region of the study participant is examined by ultrasound or MRI respectively. The contrast agent allows for the assessment of the local blood flow. In case of an infection, the inflammation process leads to an enhanced perfusion compared to non-unions without infection.
This difference in perfusion shall be used to distinguish between possible reasons for impaired bone healing and allow adaptation of therapeutic concepts.
Possible study participants are patients with a non-union before operation.

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Brief Summary in Scientific Language

Infected non-unions can often not be identified safely before surgery, but need specific therapeutic strategies. A previous pilot study revealed, that infection leads to enhanced perfusion at the fracture gap. Contrast-enhanced ultrasound (CEUS), as well as DCE-MRI allow for the visualization and quantification of the non-union tissue perfusion. Especially in combination, these methods have the potential to reveal a local infection preoperatively.
The aim of this study is to evaluate perfusion in CEUS and DCE-MRI as a preoperative marker for infected non-unions. As a reference, the results of microbiological testing of non-union tissue samples acquired during surgery will be used. The results of the previous pilot study can be verified on the basis of a larger patient collective. Furthermore, cut-off values can be determined for perfusion parameters, at which infection of a non-union is likely.

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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

  •   DRKS00012833
  •   2018/01/10
  •   [---]*
  •   yes
  •   Approved
  •   S-033/2014, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   U1111-1199-8989 
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Health Condition or Problem studied

  •   M84.1 -  Nonunion of fracture [pseudarthrosis]
  •   M96.0 -  Pseudarthrosis after fusion or arthrodesis
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Interventions/Observational Groups

  •   CEUS (Contrast-enhanced ultrasound) and DCE MRI (dynamic contrast-enhanced MRI) in patients with a non-union and positive result of microbiological testing of non-union tissue samples acquired intraoperatively
  •   CEUS and DCE MRI in patients with a non-union and negative result of microbiological testing of non-union tissue samples acquired intraoperatively
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

Diagnostic quality of preoperative hyperperfusion in CEUS (Contrast-enhanced ultrasound) / DCE-MRI (dynamic contrast-enhanced MRI) for the detection of infected non-unions.

A prospective study-design including preoperative and 12-week-followup CEUS examinations as well as preoperative and 12-week, 6-months, and 12 months-followup DCE-MRI examinations.

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Secondary Outcome

- Psychosocial evaluation: SF-12, preoperatively as well as 12 weeks, 6 months and 12 months postoperatively
- Pain: Visual analog scale, preoperatively as well as 12 weeks, 6 months and 12 months postoperatively

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/09/19
  •   200
  •   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

- Patient with non-union and indication for surgical treatment

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Exclusion Criteria

- congenital pseudarthrosis
- severe heart failure (NYHA III/IV)
- myocardial infarction within the last 14 days
- severe respiratory diseases
- pregnancy and breastfeeding
- known intolerance for SonoVue
- Missing informed consent form
- contraindication for DCE-MRI



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Addresses

  • start of 1:1-Block address primary-sponsor
    • Deutsche Gesellschaft für Ultraschall in der Medizin (DEGUM) e.V.
    • Ms.  Sabrina  Reuter 
    • Schiffbauerdamm 40
    • 10117  Berlin
    • Germany
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    • Universität Heidelberg, Zentrum für Orthopädie, Unfallchirurgie und Paraplegiologie
    • Mr.  PD Dr. med.  Christian Alexander  Fischer 
    • Schlierbacher Landstraße 200a
    • 69118  Heidelberg
    • Germany
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    • Universität Heidelberg, Zentrum für Orthopädie, Unfallchirurgie und Paraplegiologie
    • Mr.  PD Dr. med.  Christian Alexander  Fischer 
    • Schlierbacher Landstraße 200a
    • 69118  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Universität Heidelberg, Zentrum für Orthopädie, Unfallchirurgie und Paraplegiologie
    • Mr.  PD Dr. med.  Christian Alexander  Fischer 
    • Schlierbacher Landstraße 200a
    • 69118  Heidelberg
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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