Trial document




drksid header

  DRKS00021110

Trial Description

start of 1:1-Block title

Title

Diagnostic Performance of 4D-CT in Diagnostics of SLL Ruptures/ACTION: Accuracy of 4D-CT for Diagnosing Instable ScaphOlunate DissociatioN

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

Trial Acronym

ACTION

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

URL of the Trial

[---]*

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

Brief Summary in Lay Language

Injuries of the ligaments of the wrist occur frequently after trauma. Tears of the scapholunate ligament (SLL) are most common but late diagnosis and therapy of unstable injuries can still lead to osteoarthritis. Various radiological techniques are used to detect these injuries. Some of these methods are straight forward like radiographs and MRI but cannot differentiate between stable and unstable injuries. Other methods include dynamic evaluations but these methods are often complex especially in an out-patient setting. Additionally, all diagnostic methods are prone to uncertainties, which is why surgeons still prefer intraoperative evaluation of ligaments and stability during an arthroscopy. Modern technology enables dynamic four-dimensional CT (4D-CT) during a quick and easy examination protocol. In this prospective study we want to evaluate the accuracy of this technique compared an older method (cineradiography) which was used until last year at the study site: Patients with typical symptoms of scapholunate ligament tears and a need for surgical exploration (arthroscopy) are asked to participate in this study. Irrespectively of study participation, stability of the wrist will be assessed before the operation through 4D-CT. Results of 4D-CT and operative results will be compared for all participants and correlated to the results of a historical patient cohort.

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

Brief Summary in Scientific Language

Injuries of the carpal ligaments are common causes for wrist pain and can lead to osteoarthritis and invalidity. Tears of the scapholunate ligament (SLL) are the most common cause of carpal instability. Attempts to detect these injuries at an early stage and to avoid unnecessary arthroscopies in stable SLL tears have led to new radiological approaches. Conventional radiography, MRI and CT solely detect static forms of SLL injuries. Dynamic approaches aim to illustrate carpal arrangements in motion and insufficient stabilisation of the joints. Cineradiography has been widely used to analyse carpal kinematics. Implementation of super-fast dual source CT scanners created another method of dynamic imaging. Image quality of 4-dimensional computed tomography (4D) CT of the wrist is high and recent studies have shown a good interobserver reliability for analysis of wrist kinematics. As a quick and feasible method 4D CT might be a reliable tool in hospitals and health care centres.
Up until today arthroscopy is the only reliable method do discern unstable SLL tears. This prospective study aims to compare diagnostic accuracy of 4D-CT in diagnosing unstable SLL tears. Patients with typical symptoms of an SLL tear and indication for arthroscopy are offered participation in this study. Irrespectively of study participation, stability of the wrist will be assessed before the operation through 4D-CT. The minimum/maximum SL distance, SL angle and the radiolunate angle will serve as primary markers to classify stability. Results of 4D-CT and operative results are compared for all participants and correlated to the results of a historical patient cohort which was diagnosed through cineradiography and arthroscopy before imple-mentation of 4D CT at the study site.

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?

Yes

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

Description IPD sharing plan:

Available upon request

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

Organizational Data

  •   DRKS00021110
  •   2020/05/12
  •   [---]*
  •   yes
  •   Approved
  •   BB 067/20, Ethikkommission an der Medizinischen Fakultät der Ernst-Moritz-Arndt-Universität Greifswald
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1249-7884 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   S63 -  Dislocation, sprain and strain of joints and ligaments at wrist and hand level
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   40 prospectively enrolled patient with symptoms of SLL tears and indication for arthroscopy. Stability of the SLL is assessed before the operation through 4D-CT (index test) irrespectively of study participation. Results of 4D-CT and operative results (gold-standard = reference test) are compared to discern diagnostic accuracy of 4D CT to detect instable SLL tears.
  •   Retrospective enrollment of 80 consenting patients which were diagnosed with cineradiography (index test) prior to arthroscopy (gold-standard = reference test) for suspected SLL tears before implementation of 4D CT.
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)
  •   [---]*
  •   Historical
  •   Diagnostic
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Differentiation between stable and unstable SL-ligament injury

a. by 4D-CT and cineradiography
b. by SL gap, SL angle, RL angle
c. confirmation by arthroscopy

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

Secondary Outcome

Sensitivity and specificity of
a. 4D-CT and cineradiography as index test and
b. arthroscopy as gold standard
c. by determination of ROC and AUC

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

Countries of Recruitment

  •   Germany
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

  •   Planned
  •   2020/05/17
  •   120
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Suspicion of SL ligament injury
Indication for arthroscopy
no relevant comorbidities
written consent

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

Exclusion Criteria

language barrier
4D-CT not possible
pregnancy

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Radiologie und Neuroradiologie, Unfallkrankenhaus Berlin
    • Ms.  Dr. med.  Leonie  Gölz 
    • Warener Str. 7
    • 12683  Berlin
    • Germany
    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
    • Unfallkrankenhaus Berlin, Abteilung für Hand-, Replantations- und Mikrochirurgie
    • Ms.  Dr. med.  Ariane  Asmus 
    • Warener Str. 7
    • 12683  Berlin
    • Germany
    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
    • Klinik für Radiologie und Neuroradiologie, Unfallkrankenhaus Berlin
    • Ms.  Dr. med.  Leonie  Gölz 
    • Warener Str. 7
    • 12683  Berlin
    • Germany
    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
    • Klinik für Radiologie und Neuroradiologie, Unfallkrankenhaus Berlin
    • Ms.  Dr. med.  Leonie  Gölz 
    • Warener Str. 7
    • 12683  Berlin
    • Germany
    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
    • Klinik für Radiologie und Neuroradiologie, Unfallkrankenhaus Berlin
    • Ms.  Dr. med.  Leonie  Gölz 
    • Warener Str. 7
    • 12683  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Enrolling by invitation
  •   [---]*
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.