Compare sensitivity and specificity of both rules as well as compare the accuracy between observer groups for these rules. Also the interobserver agreement is assessed to test whether the rules are reproducible.
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sensitivity and specificity of both observer groups compared between the two
rules
Secondary outcome
Interobserver agreement of both rules
Background summary
For ankle sprains, the Ottawa ankle rules are developed, pertaining a decision
rule that accurately detects fractures, however still many x-rays need to be
made to detect these fractures. Therefore, still many patients undergo
unnecessary radiography. In Bern, a decision rule for the ankle has been
developed that has been claimed to have a much higher specificity (91%)
together with a 100% sensitivity. This would mean a large reduction in
unnecessary x-rays, with less radiation, waiting time and costs as a result.
However, this rule has not been validated by an independent researchgroup and
therefore needs to be carefully interpreted.
Study objective
Compare sensitivity and specificity of both rules as well as compare the
accuracy between observer groups for these rules. Also the interobserver
agreement is assessed to test whether the rules are reproducible.
Study design
Cross sectional, interobserver trial
Study burden and risks
Extra patients undergo radiation exposure as well as prolonged ED waiting time
due to the investigation
Koningin Julianaplein 58
Zaandam 1502DB
NL
Koningin Julianaplein 58
Zaandam 1502DB
NL
Listed location countries
Age
Inclusion criteria
Patients with ankle sprain
Age 18-65 yr
Presentation ED within 48 hr after trauma
Exclusion criteria
prior ankle fracture on ipsilateral side
open fractures
concomittant participation in other trial
mental or physical impairment prohibiting clinical judgment
ankle trauma as part of polytrauma
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL43168.094.13 |