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

Recruiting

• Conditions: rheumatiod and psoriatic arthritis of the wirst; wrist arthritis; 10023213; 10005944

• Registration Number: NL-OMON56165
• Lead Sponsor: Maasstadziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 80

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

- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Patient-Rated Wrist Evaluation (PRWE), 3 months after intervention</p><br>

Secondary Outcome Measures

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