Accuracy of intra-articular injections to the ankle with 2-mm diameter arthroscopy: a pilot study

Completed

Conditions: osteoarthritis
10005944
arthritis
10023213

Registration Number: NL-OMON48310

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is injection accuracy. An injection is accurate if it<br /><br>is delivered intra-articular. Intra-artiuclar delivery is confirmed with the<br /><br>arthroscopic view.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Patient maximum discomfort during the procedure, as measured by a numeric<br /><br>rating scale of pain<br /><br>- Patient preferences if any prior injections to the ankle were delivered by<br /><br>conventional injection techniques<br /><br>- The number and nature of adverse events<br /><br>- The number and nature of serious adverse events<br /><br>- Treatment effect as measured by pre- and post-injection differences in:<br /><br>* NRS of pain during rest, walking, running and climbing stairs<br /><br>* AOFAS ankle score as measured by the physician</p><br>