Diagnostic accuracy of common imaging methods to recognise internal derangement and ligamental tears of the carpus

Completed

• Conditions: Traumatic scapholunar (SL) dissociation; Injury, Occupational Diseases, Poisoning; Dislocation, sprain and strain of joints and ligaments at wrist and hand level

• Registration Number: ISRCTN57744239
• Lead Sponsor: Deutsche Arthrose-Hilfe e.V. (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-08
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 230

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Cost-effectiveness. All outcomes will be assessed by the time of hospital discharge.