Trial document




This trial has been registered retrospectively.
drksid header

  DRKS00014337

Trial Description

start of 1:1-Block title

Title

Clinical evaluation of semi-automatic open-source algorithmic software segmentation of the mandibular bone

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

enFaced

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

https://www.tugraz.at/index.php?id=26448

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Computer-assisted technologies such as image-based segmentation play an important in the diagnosis and treatment support in oral- and maxillofacial surgery. However, although many image-based segmentation approaches exist, their clinical in-house use is often strongly limited due to technical, human or financial resources. Especially in open-source based segmentation, systematic evaluations of segmentation approaches are lacking. Therefore, the aim of this study is to assess the real segmentation quality of a commonly available and license-free segmentation method in the mandible. The assessment is done in a comparison between segmented CT-image data of the mandible. Segmented patient-specific clinical image data performed by an automatic segmentation algorithm are compared with the manual ground truth segmentations performed by clinical experts. Assessment parameters are amongst others the Dice Score Coefficient (DSC, %) and the Hausdorff Distance (HD, voxel).
This study is a systematic comparison that evaluates a license-free, open-source segmentation approach in the mandible based on clinical CT-data for the improvement of segmentation algorithms and a potential clinical use in patient-individualized medicine in the field of oral and maxillofacial surgery. Further, the results presented are reproducible by others and can be used for both clinical and research purposes.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Computer-assisted technologies such as image-based segmentation play an important in the diagnosis and treatment support in oral- and maxillofacial surgery. However, although many image-based segmentation approaches exist, their clinical in-house use is often strongly limited due to technical, human or financial resources. Especially in open-source based segmentation, systematic evaluations of segmentation approaches are lacking. Therefore, the aim of this study is to assess the real segmentation quality of a commonly available and license-free segmentation method in the mandible. The assessment is done in a comparison between segmented CT-image data of the mandible. Segmented patient-specific clinical image data performed by an automatic segmentation algorithm are compared with the manual ground truth segmentations performed by clinical experts. Assessment parameters are amongst others the Dice Score Coefficient (DSC, %) and the Hausdorff Distance (HD, voxel).
This study is a systematic comparison that evaluates a license-free, open-source segmentation approach in the mandible based on clinical CT-data for the improvement of segmentation algorithms and a potential clinical use in patient-individualized medicine in the field of oral and maxillofacial surgery. Further, the results presented are reproducible by others and can be used for both clinical and research purposes.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00014337
  •   2018/05/04
  •   [---]*
  •   yes
  •   Approved
  •   EK-29-143 ex 16/17, Ethikkommission der Medizinischen Universität Graz
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   bone fracture, bone defect
  •   S02 -  Fracture of skull and facial bones
  •   K10 -  Other diseases of jaws
  •   K07 -  Dentofacial anomalies [including malocclusion]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Establishment of a CT database of the mandible with datasets from the clinical routine for the evaluation of an image-based computer program.
  •   Automatic lower jawbone segmentation with an open-source algorithm on CT data basis: 1 time of measurement (T) with Hausdorff Distance (HD, voxel)/ Dice Similarity Score (DSC, %)/ Volume (V, mm3)/ Voxel (Vx, Number)/ Time (t, min., sec.)
  •   Manual lower jawbone segmentation by clinical experts (Ground Truth) on CT data basis: 1 time of measurement (T) with Hausdorff Distance (HD, voxel)/ Dice Similarity Score (DSC, %)/ Volume (V, mm3)/ Voxel (Vx, Number)/ Time (t, min., sec.)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Comparison image based segmentation of lower jaw CT-data between automatic (algorithm) vs. manual (clinical experts) at measurement point T by Hausdorff Distance (HD, voxel) and Dice Similarity Score (DSC, %).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Comparison image based segmentation of lower jaw CT-data between automatic (algorithm) vs. manual (clinical experts) at measurement point T by Volume (V, mm3), Voxel (Vx, Number), time (t, min., sec.).

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Austria
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2017/04/01
  •   10
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

• Physiologically functional, complete lower jawbones
• Age ≥18 Years
• Age <99 Years
• Data due to the medical indication in the clinical diagnostic at the department of Oral and maxillofacial surgery

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

• Implants or osteosynthesis material
• Age <18 Years
• Lower jawbone necrosis or pathologic-cystic changes of the bones

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Medizinische Universität Graz
    • Mr.  DDDr.  Jürgen  Wallner 
    • Auenbrugger Platz 1
    • 8036  Graz
    • Austria
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • TU Graz
    • Mr.  Dr. Dr. habil.  Jan  Egger 
    • Inffeldgasse 16c/2
    • 8010  Graz
    • Austria
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Medizinische Universität Graz
    • Mr.  DDDr.  Jürgen  Wallner 
    • Auenbruggerplatz 5/1
    • 8036  Graz
    • Austria
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Medizinische Universität Graz
    • Mr.  DDDr.  Jürgen  Wallner 
    • Auenbruggerplatz 5/1
    • 8036  Graz
    • Austria
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Fonds zur Förderung der wissenschaftlichen Forschung (FWF)
    • Sensengasse 1
    • 1090  Wien
    • Austria
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Austrian Science Fund (FWF) KLI 678-B31: “enFaced: Virtual and Augmented Reality Training and Navigation Module for 3D-Printed Facial Defect Reconstructions” (PIs: Jürgen Wallner and Jan Egger)
    • 1090  Wien
    • Austria
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   [---]*
  •   [---]*
  •   2019/05/06
  •   0
  •   10
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.