Contact information
Type
Scientific
Primary contact
Dr Andreas Eisenschenk
ORCID ID
Contact details
Dept of Hand-
Micro-
and Replantation Surgery
Unfallkrankenhaus Berlin Trauma Centre
Berlin
12683
Germany
andreas.eisenschenk@ukb.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ACCORDS_V1.2_2007
Study information
Scientific title
Accuracy of common radiological methods to diagnose scapholunar dissociation: a prospective diagnostic efficacy study
Acronym
ACCORDS
Study hypothesis
To determine the diagnostic accuracy of common imaging methods (i.e., conventional and functional radiography, arthrography, computed tomography, magnetic resonance imaging [MRI] and MR-arthrography) for determining traumatic tears of the scapholunar (SL) ligament compared to the diagnostic gold standard of wrist arthroscopy.
Ethics approval
Charité University Medical Centre Ethics Committee gave approval on the 3rd September 2007 (ref: EA1/152/07)
Study design
Prospective diagnostic accuracy (efficacy) observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet (German only)
Condition
Traumatic scapholunar (SL) dissociation
Intervention
Experimental tests:
Routine radiological imaging procedures (i.e., plain radiographs, cineradiography, arthrography, computed tomography, magnetic resonance arthrography).
Reference standard:
Wrist arthroscopy.
Diagnostic test accuracy will be investigated. All imaging procedures will take no longer than one hour, and wrist arthroscopy no longer than two hours (depending on intra-operative findings and the need for surgical repair). The study-specific follow-up ends at hospital discharge, since all information necessary to answer the study questions will have been collected at this time.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Diagnostic accuracy (i.e., sensitivity, specificity, areas under the receiving operating characteristics [AUC/ROC]) of all established imaging methods compared to the diagnostic reference standard (i.e., wrist arthroscopy). All outcomes will be assessed by the time of hospital discharge.
Secondary outcome measures
Cost-effectiveness. All outcomes will be assessed by the time of hospital discharge.
Overall trial start date
01/01/2009
Overall trial end date
01/01/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male and female patients aged 18 to 65 years
2. Considered to require wrist arthroscopy due to:
2.1. Exposure to an injury to the wrist (i.e., hyperextension, contusion, extra-articular radial fractures) suitable to cause SL-tears
2.2. Persistent pain and/or other symptoms for greater than 4 weeks
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
230
Participant exclusion criteria
1. Pregnancy
2. Renal insufficiency
3. Known allergy to contrast media
4. Relative or absolute contraindication to MRI scanning
5. Previous operations to the affected wrist
6. Rheumatoid arthritis
7. Open fractures or other conditions deemed to require immediate surgical intervention
Recruitment start date
01/01/2009
Recruitment end date
01/01/2011
Locations
Countries of recruitment
Germany
Trial participating centre
Dept of Hand-, Micro-, and Replantation Surgery
Berlin
12683
Germany
Sponsor information
Organisation
Deutsche Arthrose-Hilfe e.V. (Germany)
Sponsor details
Postfach 11 05 51
Frankfurt/Main
60040
Germany
service@arthrose.de
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Deutsche Arthrose-Hilfe e.V. (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary