Arthroscopic Synovectomy of the Wrist in Inflammatory Arthritis
- Conditions
- Wrist ArthritisSurgeryPsoriatic ArthritisRheumatoid Arthritis
- Interventions
- Procedure: Arthroscopic synovectomy of the wristDrug: Intra-articular corticosteroid injection
- Registration Number
- NCT04755127
- Lead Sponsor
- Maasstad Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description arthroscopic synovectomy Arthroscopic synovectomy of the wrist Wrist arthroscopy in day surgery setting with debulking of synovitis, inspection of cartilage, ligament, tendon and bone damage, collection of synovial biopsies and deposition of intra-articular corticosteroids (40mg triamcinolone acetonide) Intra-articular corticosteroid injection Intra-articular corticosteroid injection Injection with 40mg triamcinolone acetonide (kenacort) in the wrist
- Primary Outcome Measures
Name Time Method Patient-Rated Wrist evaluation (PRWE) 3 months 15-item questionnaire scoring pain and wrist function on a scale from 0-100, with a higher score indicating worse outcome.
- Secondary Outcome Measures
Name Time Method Wrist ultrasound 3 months Resolution of ultrasound (US) arthritis as defined by grey scale (B-mode) and power Doppler after three months compared to baseline measurement. Grey scale uses a two-dimensional image to visualize structural changes like synovial hypertrophy and bone erosions. Power Doppler mode can assess joint inflammatory activity by detecting pathological synovial blood flow. The EULAR-OMERACT (Outcome Measures in Rheumatology Clinical Trials) combined scoring system includes both greyscale and power Doppler and will be used to score arthritis in this study. Ultrasound has demonstrated greater sensitivity than clinical assessment and conventional radiography for detecting synovitis in RA target joints. Also, US signs of synovitis were found predictive for flare and failure of DMARD therapy, despite clinical remission. Furthermore, ultrasound techniques are low-invasive, inexpensive and require no radiation.
NRS pain score 2, 4 and 6 weeks, 3, 6 and 12 months Numeric Rating Scale (NRS) pain score at baseline two, four and six weeks (by phone), and at three, six and twelve months (digitally). A score of 0 implies no pain and 10 the worst possible pain.
Patient-Rated Wrist evaluation (PRWE) 6 and 12 months 15-item questionnaire scoring pain and wrist function on a scale from 0-100, with a higher score indicating worse outcome.
EQ-5D 3, 6 and 12 months EuroQol 5D (EQ-5D) at baseline, three, six and twelve months. The EQ-5D is a standardized questionnaire scoring quality of life on five different levels, on a scale from 0-100.
iPCQ questionnaire 3, 6 and 12 months Institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ) at baseline, three, six and twelve months. The iPCQ is a standardized instrument for measuring and valuing health related productivity losses. This wil be used for the cost effectiveness analysis.
iMCQ questionnaire 3, 6 and 12 months Institute for Medical Technology Assessment (iMTA) Medical Consumption Questionnaire (iMCQ) at baseline, three, six and twelve months. The iMCQ is a standardized instrument for measuring medical costs. The iMCQ includes questions related to frequently occurring contacts with health care providers, medication use and home care. This wil be used for the cost effectiveness analysis.
ESR 3, 6 and 12 months Laboratory test: erythrocyte sedimentation rate (ESR) at baseline and three, six and twelve months (part of the routine clinical care).
CRP 3, 6 and 12 months Laboratory tests: C-reactive protein (CRP) at baseline and three, six and twelve months (part of the routine clinical care).
Range of motion 3, 6 and 12 months Range of motion (ROM) of the wrist at baseline, three, six and twelve months. ROM will be measured actively with a goniometer and includes pronation, supination, ulnar and radial deviation and palmar and dorsal flexion.
Grip strength 3, 6 and 12 months Grip strength of the wrist at baseline, three, six and twelve months. Grip strength will be measured using a dynamometer as the mean of three measurements.
Wrist X-ray 12 months Standard (plain) radiographs of the wrist at baseline and after twelve months. Arthritis on radiographs will be graded using the Modified Larsen grading system. This system grades wrist arthritis on a score of 0 to 5, 5 indicating the most joint abnormalities.
DAS 28 3, 6 and 12 months EULAR response rate and Disease Activity Score (DAS28) at baseline, three, six and twelve months. The DAS28 is a measure of disease activity in rheumatoid arthritis in which 28 joints are examined for swelling and tenderness, combined with global pain scores and blood markers (www.DAS28-score.nl). The EULAR response rate measures responsiveness to anti-rheumatic treatment and is derived from the DAS28 score
Adverse events One year Adverse events (AEs) (including glucocorticoid related AEs), AEs leading to withdrawal, AEs leading to discontinuation of medication, and AEs due to infusion reactions.
Trial Locations
- Locations (1)
Maasstad Hospital
🇳🇱Rotterdam, Zuid-Holland, Netherlands