Surgery to relieve wrist arthritis symptoms in patients with inflammatory arthritis
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
This study is testing a minimally invasive wrist surgery to see if it can help people with inflammatory arthritis feel better when other treatments aren't working.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maasstad Hospital Academic / other |
| Locations | 1 site (Rotterdam, Zuid-Holland) |
| Trial ID | NCT04755127 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of arthroscopic synovectomy of the wrist in patients suffering from inflammatory arthritis, specifically rheumatoid arthritis and psoriatic arthritis. The study aims to provide an alternative treatment option for patients who do not respond adequately to conventional disease-modifying anti-rheumatic drugs and corticosteroid injections. By performing this minimally invasive surgical procedure, the researchers hope to alleviate symptoms, improve wrist functionality, and slow disease progression. The trial will include patients who meet specific criteria related to their arthritis diagnosis and treatment history.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with rheumatoid arthritis or psoriatic arthritis who have not responded to conventional treatments.
Not a fit: Patients with mild arthritis or those who have not experienced exacerbations may not benefit from this surgical intervention.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients with inflammatory arthritis by reducing symptoms and preventing further joint damage.
How similar studies have performed: Previous studies have suggested that arthroscopic synovectomy can provide symptom relief in similar patient populations, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria In order to be eligible to participate in this study, a subject must meet all of the following criteria: * Male and female patients with age ≥ 18 years * Subjects able and willing to give written informed consent (or legally acceptable representative or impartial witness when applicable) and is available for entire study * Patients meet the criteria of either group below: Group 1. Inclusion criteria RA patients: * Patients that are diagnosed with RA according to the revised 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Rheumatoid Arthritis Classification Criteria (table 1) * 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 six months before) * The exacerbation is refractory to systemic cDMARDs for at least three months, defined as 'no response' according to the EULAR response criteria (table 2) * Wrist arthritis, that is diagnosed clinically, is the predominant symptom Group 2. Inclusion criteria PsA patients: * Patients that are diagnosed with PsA according to the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria (table 3) * 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 six months before) * The exacerbation is refractory to systemic cDMARDs for at least three months, defined as 'no response' according to the EULAR response criteria (table 2) * Wrist arthritis, that is diagnosed clinically, is the predominant symptom Exclusion criteria A potential subject who meets any of the following criteria will be excluded from participation in this study: * Previous or current treatment 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 6 months * Previous wrist surgery * Severe osteoarthritis with malformations of the wrist * Congenital abnormalities of wrist function or motion
Where this trial is running
Rotterdam, Zuid-Holland
- Maasstad Hospital — Rotterdam, Zuid-Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Radjesh Bisoendial, MD, PhD — Maasstad ziekenhuis
- Study coordinator: Philip d'Ailly, MD
- Email: daillyp@maastadziekenhuis.nl
- Phone: 31102912205
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.