arthritis osteoarthritis
Conditions
Interventions
A hyaluronic acid injection is administered to the ankle as planned. The
injection is performed trough 2-mm diameter arthroscopy. There is no control
group.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Consented to a injection with hyaluronic acid to the ankle as treatment for osteoarthritis - Is between 18 and 80 years of age - Is able to understand the Dutch or English language - Is capable of understanding the nature of the study - Is able to provide written informed consent - Agrees to a follow-up visit to the outpatient office
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Active infection at the time of injection or inclusion, either systemic or locally at the planned injection site - Bleeding disorders - Excessive difficulty or health risk caused by arthroscope introduction, as expected by the treating surgeon - Unavailable on the planned intervention day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is injection accuracy. An injection is accurate if it is delivered intra-articular. Intra-artiuclar delivery is confirmed with the arthroscopic view. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Patient maximum discomfort during the procedure, as measured by a numeric rating scale of pain - Patient preferences if any prior injections to the ankle were delivered by conventional injection techniques - The number and nature of adverse events - The number and nature of serious adverse events - Treatment effect as measured by pre- and post-injection differences in: * NRS of pain during rest, walking, running and climbing stairs * AOFAS ankle score as measured by the physician | — |
Countries
Netherlands
Outcome results
None listed