The primary objective is to confirm the accuracy of 2-mm diameter arthroscopy guided intra-articular injections to the ankle in a patient setting.
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
- 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
Background summary
Intra-articular injections play an important role in orthopaedic surgery,
especially in the treatment of osteoarthritis. Innovative injectables promise
to further increase the importance of injections as a modality for minimally
invasive treatment. Nonetheless, injection accuracy is often limited at best,
especially for smaller joints such as the ankle. Inaccurate injection leads to
a lost treatment effect and can have a detrimental influence on extra-articular
soft tissue. A novel needle-like arthroscopic system with CE-marking was
recently released. This system uses a 2-mm diameter, disposable arthroscope and
a tablet-like video console. Despite its substantially smaller diameter, the
system obtains high quality images. In a cadaveric setting, the system provided
100% accuracy in intra-articular injections to the ankle, where injections were
delivered through the arthroscope itself. That is, injected media flowed
between the arthroscope and its cannula into the joint. We hypothesize that
with 2-mm diameter arthroscopy, intra-articular injections can likewise be
delivered with 100% accuracy in a patient setting.
Study objective
The primary objective is to confirm the accuracy of 2-mm diameter arthroscopy
guided intra-articular injections to the ankle in a patient setting.
Study design
Cross-sectional pilot study
Intervention
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.
Study burden and risks
Burden & risks:
- Arthroscope introduction causes a minimally larger (1.2 mm larger) skin
incision compared to standard practice
- Pre- and post-injection questionnaires and one additional follow-up visit to
the outpatient office
- General injection associated risks (infection, neurvascular damage, cartilage
damage)
Benefits:
- Expected increase in injection accuracy and hence an increase of the change
of a positive treatment effect
- Decreased change of injection-associated iatrogenic damage to neurovascular
structures and intra-articular cartilage
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL71185.018.19 |