Arthroscopic Synovectomy of the Wrist in Inflammatory Arthritis

Launched by MAASSTAD HOSPITAL · Feb 11, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a surgical procedure called arthroscopic synovectomy for patients with wrist arthritis, specifically those with rheumatoid arthritis or psoriatic arthritis. The study aims to compare the effectiveness of this surgery, combined with a specific type of corticosteroid injection, to a standard injection of corticosteroids alone for patients who have not responded well to other treatments. The goal is to see if the surgery can provide better relief from pain and improve function in the wrist, ultimately enhancing the quality of life for participants.

To be eligible for this trial, participants must be adults aged 18 or older with active rheumatoid arthritis or psoriatic arthritis affecting the wrist, and they must have experienced a flare-up of their condition that has not improved with standard medication for at least three months. Participants will undergo the procedure and will have follow-up visits to monitor their progress at three, six, and twelve months. During the study, they will complete questionnaires about their wrist pain and function. It’s important to note that while wrist arthroscopy is generally safe, there are some risks involved, such as infection or damage to surrounding structures. However, the procedure is well-established, and the healthcare team will take steps to minimize risks.

Gender

ALL

Eligibility 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