Arthroscopic Synovectomy versus Intra-articular Injection of Corticosteroids for the Management of Therapy Refractory Psoriatic or Rheumatoid Arthritis of the Wrist: a Randomized Controlled Trial

Psoriatic (PsA) and rheumatoid arthritis (RA) are inflammatory joint diseases
that often involve the wrist and may result in progressive joint destruction
followed by impaired wrist function and reduced quality of life. The first line
treatment consists of conventional Disease-Modifying Anti-Rheumatic Drugs
(cDMARDs) along with bridging therapy using systemic corticosteroids or
intra-articular corticosteroids. After initiation of therapy, intra-articular
corticosteroid injections are often utilized as they provide rapid dampening of
joint inflammation in case of a localized flare of disease activity (mono- or
oligoarthritis). However a substantial part of these patients clinically
respond poorly or not at all. Alternatively, arthroscopic synovectomy is a low
risk intervention that may provide substantial relieve of symptoms, improve
functionality, slow down disease progression and prevent joint destruction, as
earlier studies have suggested. Prospective randomized studies are needed to
confirm these findings. Moreover, arthroscopic synovectomy may prevent the need
for expensive biological (b)DMARDs and assist in guiding therapeutic strategies
in the long run, through collecting and analyzing valuable synovial biopsies.

The objective of this study is to demonstrate that arthroscopic synovectomy of
the wrist comined with deposition of intra-articular corticosteroids (DIACS)
will lead to better functional outcomes compared to intra-articular
corticosteroid injection (IACSI) in cDMARD resistant RA and PsA patients.

The ARCTIC-trial is a multicenter randomized controlled trial in the Maastad
hospital in Rotterdam, Spijkenisse Medisch Centrum (SMC) in Spijkenisse,
Erasmus Medical Center (EMC) in Rotterdam, Franciscus Gasthuis & Vlietland
(FGV) in Rotterdam, Leiden University Medical Center (LUMC) in Leiden, Albert
Schweitzer hospital in Dordrecht (ASZ), Amphia hospital in Breda (AZ), van Weel
Bethesda Hospital (vWB) in Dirksland, IJsselland Hospital (YSZ) in Rotterdam
and Haaglanden Medical Center (HMC) in Den Haag. Study inclusion and follow-up
will take place in the Maasstad hospital. The EMC, FGV, LUMC, ASZ, AZ, vWB, YSZ
and HMC will only prescreen patients and not perform any study procedures.
Wrist arthroscopies will be performed in the Maasstad hospital and in the SMC.
Because the intervention involves surgery, the study will not be blinded.

This study will randomize between arthroscopic synovectomy of the wrist
combined with deposition of intra-articular corticosteroids (DIACS) and
intra-articular corticosteroid injection (IACSI) of the wrist.

Risks:
The intervention group will receive wrist arthroscopy, which is often
implemented for intra-articular wrist pathology. The risks include those
related to anaesthesia, infection, neurovascular damage and articular surface
damage. Nevertheless, wrist arthroscopy is a well-established and safe
technique. Close follow up and a protocol of treatment, identical to the
standard one, will be applied in every subject. Reduction of risks will be done
according to inclusion and exclusion criteria. If complications arise, the
treating physician will proportionate the adequate treatment according to the
current protocols of treatment based on the published literature.
IACSI is standard treatment of care. Risks are very low and include hemorrhage,
infection and pain at the injection site.

Burden:
Patients will be asked to return at 3, 6 and 12 months. These visits are
standard of care following the rheumatic arthritis protocol. During these
visits, patients will be asked to complete 3 questionnaires. This will take 40
minutes for each visit (including baseline measurements, this will be 160
minutes in total). The arthroscopy group will return between 10-14 days for
wound inspection, which is standard. All patient will be contacted by telephone
at 2, 4 and 6 weeks for VAS pain scores, which will take no longer than 5
minutes.
Anti-rheumatic therapy will be temporarily stoppen before intervention and
cannot be changed in the first three months after intervention.