ANKLE TRIA
Recruiting
- Conditions
- Acute ankle sprainEnkelbandletsel
- Registration Number
- NL-OMON21996
- Lead Sponsor
- fund=initiator=sponsor
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 165
Inclusion Criteria
1. ‘Healthy’ adult patients (age above 18 years), who are able to give Informed Consent;
2. Acute (less than 24 hours), single sided and first inversion ankle trauma, whereby sprain of the lateral ankle ligaments has been occurred;
Exclusion Criteria
1. Drugs- or alcohol addiction or otherwise factors that will influence compliance in a negative way;
2. Fracture, syndesmosis or medial ligament rupture, arthritis;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Foot and Ankle Outcome Score (FAOS);<br /><br>2. Karlsson scoring scale.
- Secondary Outcome Measures
Name Time Method 1. FAOS subscales: pain, other symptoms, ADL, sport en recreation, quality of life;<br /><br>2. Number of recurrent ankle injuries;<br /><br>3. VAS satisfaction;<br /><br>4. Side effects.