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 |
| Protocol serial number | ACCORDS_V1.2_2007 |
| Sponsor | Deutsche Arthrose-Hilfe e.V. (Germany) |
| Funder | Deutsche Arthrose-Hilfe e.V. (Germany) |
- 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
| Primary study design | Observational |
|---|---|
| Study design | Prospective diagnostic accuracy (efficacy) observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| 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(s) | 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. |
| Key secondary outcome measure(s) | Cost-effectiveness. All outcomes will be assessed by the time of hospital discharge. |
| Completion date | 01/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
