To investigate the feasibility of aspirating synovial fluid from small hand joints, such as interphalangeal and MCP joints of patients with hand OA and inflammatory diseases who are referred for an intra-articular injection of an inflamed joint.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• The percentage of study joints in which a successful aspiration is performed.
Secondary outcome
• The volume of the obtained synovial fluid collections (µl).
• To analyse the presence of cytokines (such as IL-1, IL-6, IL-8, TNF-α), of
immune cells (neutrophils, macrophages, lymphocytes) and adipokines and lipid
mediators in the synovial fluid.
• The relation between the US effusion score and volume of synovial fluid that
is aspirated from the study joint.
Other study parameters
• Association of physical and ultrasound inflammatory/structural features and
the ability to obtain synovial fluid (i.e. obesity, big structural
abnormalities, such as osteophytes or joint space narrowing)
• To investigate whether there is a difference in feasibility, amount of
synovial fluid and analyses between hand OA and inflammatory arthritis
(rheumatoid arthritis and psoriatic arthritis)
Background summary
Hand osteoarthritis (OA) is a prevalent disease of which the aetiology is
largely unknown. Synovitis can frequently be found in hand joints of OA
patients with the use of imaging modalities such as ultrasonography (US).
Although synovitis is thought to be involved in clinical features and
development of structural damage, its exact role is currently not elucidated.
Therefore, the investigation of synovial tissue would be of great interest.
However, synovial tissue can only be obtained via an invasive procedure, which
is not easy in small hand joints. Alternatively, it might be possible to
obtain synovial fluid, which is a reflection of the processes going on in the
synovial tissue, and is therefore also of interest to study.
Study objective
To investigate the feasibility of aspirating synovial fluid from small hand
joints, such as interphalangeal and MCP joints of patients with hand OA and
inflammatory diseases who are referred for an intra-articular injection of an
inflamed joint.
Study design
The study is set up as a pilot study, to investigate the feasibility of
aspirating synovial fluid from inflamed small hand joints of patients with OA,
rheumatoid arthritis and psoriatic arthritis. It is a single centre study and
patients will be recruited consecutively from the outpatient clinic of the
department of Rheumatology, Leiden University Medical Centre.
Patients suffering from OA, rheumatoid arthritis or psoriatic arthritis, that
are planned to have an intra-articular injection in usual care of one of the
small hand joints (interphalangeal joints or MCP joints), the study joint by
their treating doctor, will be asked to participate. If the patient is willing
to participate, an US examination will be performed of the study joint and
inflammatory features (effusion, synovial thickening and Doppler signal) will
be scored semi-quantitatively. A puncture will be performed of the study joint
and aspiration of synovial fluid will be tried. If synovial fluid is aspirated,
it will be collected and transferred to a glass vial.. Subsequently, a
corticosteroid injection will be given into the study joint.
Study burden and risks
Only patients that are already planned to have an injection in an inflamed MCP
or interphalangeal joint will be included. The puncture to obtain synovial
fluid will be performed before the injection with corticosteroids takes place,
and whenever possible the syringe will be changed so that the patient will be
only punctured once, instead of performing another puncture.
Benefits for the patients will be the fact that using US, the needle can be
placed under vision exactly within the inflamed joint allowing the medication
to be placed exactly where it is intended to be, while the chance of having a
complication is diminished (for instance due to the visualisation under US
guidance of the bone or blood vessels, the chance of damaging these tissues is
diminished.) It is thought that the US guided procedure is therefore less
painful and more effective.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
1. Diagnoses of hand OA, rheumatoid arthritis, or psoriatic arthritis according
to recognised classification criteria sets
2. Presence of an inflamed interphalangeal or MCP joint for which the treating
rheumatologist has proposed treatment with an intra-articular injection with
corticosteroids.
3. Patients should be 40 years of age or older.
Exclusion criteria
1. Patients that had an intra-articular injection with corticosteroids, an
operation or an important trauma in the same joint less than 12 weeks before
the intended injection
2. The presence of a chronic inflammatory disease (other than OA, rheumatoid
arthritis or psoriatic arthritis), such as poly-articular gout
3. Contra-indication for an intra-articular injection such as anti-coagulant
(vitamin K antagonist) use that can*t be discontinued.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL61359.058.17 |
| OMON | NL-OMON26127 |