Arthroscopic Synovectomy of the Wrist in Inflammatory Arthritis
Status:
Recruiting
Trial end date:
2023-09-01
Target enrollment:
Participant gender:
Summary
Rationale: 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 usually consists of
conventional Disease-Modifying Anti-Rheumatic Drugs (cDMARDs) along with bridging therapy
using systemic corticosteroids or intra-articular corticosteroids in case of limited joint
disease. After initiation therapy, intra-articular corticosteroids are often utilized as they
provide rapid dampening of joint inflammation in case of a flare-up of disease activity
(mono- or oligoarthritis). However, a substantial part of these patients clinically respond
poorly or not at all. Alternatively, arthroscopic synovectomy 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, they may prevent the need for expensive biological
Disease-Modifying Anti-Rheumatic Drugs (bDMARDs) and assist in guiding therapeutic strategies
in the long run, through collecting and analysing valuable synovial biopsies. Wrist
arthroscopy is a routine procedure in the participating centres with only minor complications
and fast recovery.
Objective: To compare arthroscopic synovectomy with deposition of intra-articular
corticosteroids (DIACS) versus intra-articular injection of corticosteroids (IACSI) in RA and
PsA patients with mono- or oligoarthritis of the wrist that is refractory to cDMARD therapy.
Study design: Multi-centre randomized controlled trial conducted in the Maasstad Hospital and
Spijkenisse Medisch Centrum (SMC).
Study population: Patients with active RA or PsA and bDMARD-naive, who develop a localized
flare of disease activity (mono- or oligoarthritis) that involves the wrist, defined as an
increase in DAS28 > 1.2 or > 0.6 if DAS28 ≥ 3.2 compared to the last DAS28 measurement
(maximum six months before) and that is refractory to systemic cDMARD for at least three
months, defined as no response on the European League Against Rheumatism (EULAR) response
criteria.
Intervention: This study will randomize between IACSI of the wrist (control) and arthroscopic
synovectomy of the wrist combined with DIACS (intervention). During arthroscopy synovial
biopsies will be collected and stored for later analysis of the functional and histological
characteristics of the synovium (beyond the scope of this study).
Main study parameters/endpoints: Primary outcome is the change in Patient-Rated Wrist
Evaluation (PRWE) score from randomization to three months of follow-up. The PRWE is a
validated, fifteen-item self-reported questionnaire rating wrist pain and function. Secondary
outcomes are resolution of wrist arthritis measured by ultrasound, standard wrist
radiographs, DAS28, EULAR response rate, Visual Analogue Scale (VAS), EQ-5D quality of life
questionnaire, iMTA Productivity Cost Questionnaire (iPCQ), iMTA Medical Consumption
Questionnaire (iMCQ), cost effectiveness analyses (CEA), physical examination, adverse events
(AE) and laboratory results. Follow-up visits are scheduled at three, six and twelve months
after intervention.
Nature and extent of the burden and risks associated with study participation:
Both study arms include standard treatment of care. Wrist arthroscopy is a standard treatment
for wrist arthritis and often implemented for other intra-articular wrist pathology. The
risks include infection, neurovascular damage and articular surface damage. Nevertheless,
wrist arthroscopy is a well-established and safe technique. 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 based on the
published literature. Patients will be asked to return at three, six and twelve months. These
visits are standard of care following the rheumatic arthritis protocol. Patients will be
asked to complete questionnaires at baseline and at three follow-up moments. These will take
160 minutes in total. The arthroscopy group will return between ten to fourteen days for
wound inspection. All patient will be contacted by telephone at two, four and six weeks for
VAS pain scores.
Expected results: We expect that arthroscopic synovectomy followed by DIACS will lead to
significantly more improvement in PRWE scores compared to IACSI three months after
intervention. Furthermore, we anticipate that wrist arthroscopy will result in lower pain
scores, better joint mobility, better response on EULAR score, sustained resolution of
arthritis on ultrasound, less joint damage on radiographs and is more cost-effective after
one-year analysis.