Efficacy and safety of GLucocorticoid injections into InfrapaTellar faT pad in patients with knee ostEoarthRitiS: protocol for the GLITTERS randomized controlled trial

Trials

Study Protocol

Guangfeng Ruan¹  Changhai Ding²  Yan Zhang²  Xiaoni Zhou²  Xuelian Liu²  Qing Chang³  Sili Huang³  Wenjie Hu⁴  Li Jiang⁴  Yangyang Lin⁴  Huiting Feng⁴  Tao Fan⁵  Peng Zheng⁵  Jiangshan Zhang⁶  Xiaomei Wei⁶  Juanjuan He⁶  Zhenhai Wei⁶ 

[1] Clinical Research Centre, Guangzhou First People’s Hospital, School of Medicine, South China University of Technology, Guangzhou, Guangdong, China;Clinical Research Centre, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China;Department of Rehabilitation Medicine, Beihai People’s Hospital, Beihai, Guangxi, China;Department of Rehabilitation Medicine, The Sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China;Department of Rehabilitation Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China;Department of Rehabilitation, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China;

关键词: Osteoarthritis;    Glucocorticoid;    Infrapatellar fat pad;    Randomized controlled trials;    Protocol;    GLITTERS;   

DOI  :  10.1186/s13063-022-06993-4

 received in 2022-09-03, accepted in 2022-12-07,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundKnee osteoarthritis (OA) is a prevalent disabling disorder that involves changes in articular cartilage damage, subchondral bone remodeling, synovitis, and abnormal infrapatellar fat pad (IPFP). Due to the complicated etiology and numerous phenotypes of knee OA, limited improvement is achieved for treatments among knee OA patients with different phenotypes. Inflammatory OA phenotype is a typical knee OA phenotype, and individualized treatment targeting inflammation is a promising way to obtain an optimal therapeutic effect for people with inflammatory knee OA phenotype. Glucocorticoid is a traditional anti-inflammatory drug for knee OA, and intra-articular glucocorticoid injections are recommended clinically. However, emerging evidence has shown that repeated intra-articular glucocorticoid injections in the long term would induce cartilage loss. IPFP and its adjacent synovium are considered as the main source of inflammation in knee OA. This GLITTERS trial aims to investigate if a glucocorticoid injection into the IPFP is effective and safe over 12 weeks among knee OA patients with an inflammatory phenotype.MethodsGLITTERS is a multicenter, double-blinded, randomized, and placebo-controlled clinical trial among knee OA patients with both Hoffa-synovitis and effusion-synovitis. Sixty participants will be allocated randomly and equally to either the glucocorticoid group or the control group. Each group will receive an injection of glucocorticoid or saline into the IPFP with an intra-articular hyaluronic acid injection as a background treatment at baseline and be followed at 4, 8, and 12 weeks. The primary outcomes will be changes in knee pain on a visual analog scale and effusion-synovitis volume measured on magnetic resonance imaging (MRI). The secondary outcomes will be changes in the total score of Western Ontario and McMaster Universities Osteoarthritis Index score, MRI-detected Hoffa-synovitis score, quality of life, pain medication use, IPFP volume, and the incidence of adverse reactions. Data analyses based on the intention-to-treat principle will include mixed-effects regressions, Wilcoxon rank-sum tests, and chi-square tests (or Fisher’s exact test).DiscussionGLITTERS may provide high-quality evidence for the efficacy and safety of ultrasound-guided glucocorticoid injections into IPFP among people with inflammatory knee OA in a short term. The results of this trial are expected to provide a reliable reference for a longer-term risk–benefit profile of this treatment in the future.Trial registrationClinicalTrials.gov NCT05291650. Registered on 23 March 2022.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

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