Diagnostic accuracy of common imaging methods to recognise internal derangement and ligamental tears of the carpus
| ISRCTN | ISRCTN57744239 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57744239 |
| Secondary identifying numbers | ACCORDS_V1.2_2007 |
- Submission date
- 17/03/2009
- Registration date
- 08/04/2009
- Last edited
- 08/04/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Andreas Eisenschenk
Scientific
Scientific
Dept of Hand-, Micro-, and Replantation Surgery
Unfallkrankenhaus Berlin Trauma Centre
Berlin
12683
Germany
| andreas.eisenschenk@ukb.de |
Study information
| Study design | Prospective diagnostic accuracy (efficacy) observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet (German only) |
| Scientific title | Accuracy of common radiological methods to diagnose scapholunar dissociation: a prospective diagnostic efficacy study |
| Study acronym | ACCORDS |
| Study objectives | 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(s) | Charité University Medical Centre Ethics Committee gave approval on the 3rd September 2007 (ref: EA1/152/07) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/2009 |
| Completion date | 01/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 230 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 01/01/2011 |
Locations
Countries of recruitment
- Germany
Study participating centre
Dept of Hand-, Micro-, and Replantation Surgery
Berlin
12683
Germany
12683
Germany
Sponsor information
Deutsche Arthrose-Hilfe e.V. (Germany)
Research organisation
Research organisation
Postfach 11 05 51
Frankfurt/Main
60040
Germany
| service@arthrose.de | |
| Website | http://www.arthrose.de/ |
"ROR" |
https://ror.org/05e1k0d14 |
Funders
Funder type
Research organisation
Deutsche Arthrose-Hilfe e.V. (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
