PRIMA trial
Completed
- Conditions
- Osteoarthritis of the Ankle (Ned: enkelartrose)
- Registration Number
- NL-OMON25940
- Lead Sponsor
- niversity Medical Center: Academic Medical Center Amsterdam
- Brief Summary
Chronic achilles tendinopathy by de Vos et al. JAMA 2010 (PRICT-study, registration NTR1420, ABR NL 22805.098.08). <br><br> Acute hamstring injuries by Reurink et al. NEJM 2014 (HIT-study registration NTR2771, NL34660.098.10 / 10-163; ABR / METC Zuidwest Holland).[
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1. Severity of Ankle OA pain on a visual analogue scale (VAS) (0–100 mm) ≥ 40 during daily activities
2. X-rays (AP and lateral view) indicating ≥ grade 2 on the Van Dijk classification[10]
Exclusion Criteria
1. Patient has received injection therapy for ankle OA in the previous 6 months
2. Patient does not want to receive one of the two therapies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method American Orthopaedic Foot and Ankle Society (AOFAS) score at 26 weeks follow-up,
- Secondary Outcome Measures
Name Time Method 1. Pain scores: (VAS 0-100) during activities of daily living and the pain sub-scale of AOFAS (0-40)<br /><br>2. Ankle activity score (0-10)<br /><br>3. Subjective patient satisfaction (4 categories)<br /><br>4. Health related quality of life (SF-36 scale)<br /><br>5. The Global Attainment Scaling (GAS)<br /><br>6. EQ-5D-3L utility score<br /><br>7. Ankle Osteoarthritis Score (AOS)<br /><br>8. Foot and Ankle Outcome Score (FAOS)