Arthroscopic synovectomy versus intra-articular injection of corticosteroids for the management of refractory psoriatic or rheumatoid arthritis of the wrist:study protocol for a randomized controlled trial (ARCTIC trial)

• Published in: Trials
• Main Authors: d'Ailly, P N, Deugd, C, Schep, N W L, Kuijper, T M, Kok, M R, Willemze, A, Coert, J H, de Jong, P H P, Lam-Tse, W K, van der Helm-van Mil, A H M, Tchetverikov, I, Weel-Koenders, A E A M, Bisoendial, R J
• Format: Article in Journal/Newspaper
• Language: English
• Published: 2023
• Subjects: Arctic
• Online Access: https://pure.eur.nl/en/publications/a1074696-1755-44fd-b9a0-ecc26e0a9392; https://doi.org/10.1186/s13063-023-07129-y; https://pure.eur.nl/ws/files/87308173/Arthroscopic_synovectomy_versus_intra_articular_injection_of_corticosteroids_for_the_management_of_refractory_psoriatic_or_rheumatoid_arthritis_of_the_wrist_study_protocol_for_a_randomized_controlled_trial_ARCTIC_trial.pdf; http://www.scopus.com/inward/record.url?scp=85150970069&partnerID=8YFLogxK

BACKGROUND: Rheumatoid arthritis (RA) and psoriatic arthritis (PsA) are inflammatory diseases that often affect the wrist and, when affected, can lead to impaired wrist function and progressive joint destruction if inadequately treated. Standard care consists primarily of disease-modifying anti-rheumatic drugs (DMARDs), often supported by systemic corticosteroids or intra-articular corticosteroid injections (IACSI). IACSI, despite their use worldwide, show poor response in a substantial group of patients. Arthroscopic synovectomy of the wrist is the surgical removal of synovitis with the goal to relieve pain and improve wrist function. The primary objective of this study is to evaluate wrist function following arthroscopic synovectomy compared to IACSI in therapy-resistant patients with rheumatoid or psoriatic arthritis. Secondary objectives include radiologic progress, disease activity, health-related quality of life, work participation and cost-effectiveness during a 1-year follow-up. METHODS: This protocol describes a prospective, randomized controlled trial. RA and PsA patients are eligible with prominent wrist synovitis objectified by a rheumatologist, not responding to at least 3 months of conventional DMARDs and naïve to biological DMARDs. For 90% power, an expected loss to follow-up of 5%, an expected difference in mean Patient-Rated Wrist Evaluation score (PRWE, range 0-100) of 11 and α = 0.05, a total sample size of 80 patients will be sufficient to detect an effect size. Patients are randomized in a 1:1 ratio for arthroscopic synovectomy with deposition of corticosteroids or for IACSI. Removed synovial tissue will be stored for an ancillary study on disease profiling. The primary outcome is wrist function, measured with the PRWE score after 3 months. Secondary outcomes include wrist mobility and grip strength, pain scores, DAS28, EQ-5D-5L, disease progression on ultrasound and radiographs, complications and secondary treatment. Additionally, a cost-effectiveness analysis will be performed, based on ...