Condition category
Injury, Occupational Diseases, Poisoning
Date applied
17/03/2009
Date assigned
08/04/2009
Last edited
08/04/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.arthrose.de/

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

Publication citations

Additional files

Editorial Notes