Osteoarthritis of the Ankle (Ned: enkelartrose)
Conditions
Interventions
Intra-articular injections of the ankle:
Platelet rich plasma vs Placebo (saline)
Sponsors
University Medical Center: Academic Medical Center Amsterdam
Eligibility
Inclusion criteria
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] 3. Age ≥ 18 years
Exclusion criteria
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 3. Patient has clinical signs of concomitant OA of one or more other major joints of the lower extremities that negatively affects their daily activity level 4. Previous ankle surgery for OA or Osteochondral defects (OCD) < 1 year (not including surgery for an ankle fracture in the past)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| American Orthopaedic Foot and Ankle Society (AOFAS) score at 26 weeks follow-up, | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain scores: (VAS 0-100) during activities of daily living and the pain sub-scale of AOFAS (0-40) 2. Ankle activity score (0-10) 3. Subjective patient satisfaction (4 categories) 4. Health related quality of life (SF-36 scale) 5. The Global Attainment Scaling (GAS) 6. EQ-5D-3L utility score 7. Ankle Osteoarthritis Score (AOS) 8. Foot and Ankle Outcome Score (FAOS) | — |
Contacts
Public ContactL.D.A. Paget
Amsterdam UMC
Outcome results
None listed