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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

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 - ARCTIC

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56165
Enrollment
80
Registered
2020-11-30
Start date
2021-02-04
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rheumatiod and psoriatic arthritis of the wirst wrist arthritis

Interventions

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 th

Sponsors

Maasstadziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: - Male and female patients that are 18 years or older - Patients are diagnosed with rheumatoid arthritis according to the revised 2010 ACR/EULAR Rheumatoid Arthritis Classification Criteria or with psoriatic arthritis according to the CASPAR criteria - Patients are experiencing an exacerbation defined as an increase in DAS28 > 1.2 or > 0.6 if DAS28 >= 3.2 compared to last DAS28 measurement (maximum 6 months before), or an exacerbation clinically diagnosed by a rheumatologist. - Wrist arthritis, that is clinically diagnosed, is the predominant symptom - Patients with an exacerbation, either under cDMARD treatment or no treatment specified as: • Patients with an exacerbation and are stopped with cDMARD treatment in the past due to side-effects or no effect from cDMARD treatment. • Patients with an exacerbation and can*t start cDMARD treatment due to contra-indications for cDMARD treatment. • Patients with a mono- or oligoarthritis as an exacerbation and have stopped cDMARD treatment in the past due to disease in remission. First choice of treatment in case of mono- or oligoarthritis can be local treatment before restart systemic cDMARD treatment.

Exclusion criteria

Exclusion criteria: - Current treatment or treatment within the last 12 months with biological (b)DMARDs - Current inflammatory joint disease other than RA or PsA (e.g., gout, reactive arthritis, Lyme disease) - Subjects who are pregnant or intend to become pregnant during the study - Intra-articular corticosteroids injection in the wrist in the last 3 months. - Previous wrist surgery - Severe osteoarthritis with malformations of the wrist - Congenital abnormalities of wrist function or motion - Patients with arthritis in both wrists can only participate in the study with one wrist

Design outcomes

Primary

MeasureTime frame
Patient-Rated Wrist Evaluation (PRWE), 3 months after intervention

Secondary

MeasureTime frame
- DAS28 score - Resolution of synovitis measured with ultrasound (using the EULAR-OMERACT combined scoring system) - Wrist damage measured with plain wrist radiographs - Range of motion (ROM) and grip strength of the wrist - Quality of life measured with the EQ-5D - Cost-effectiveness analysis calculated with the EQ-5D, iMCQ and iPCQ

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)