Chen Yiwei, Lin Junqing, Lin Jiali, Gao Tao, Cai Qianying, Zhang Changqing, Zhu Hongyi, Shen Longxiang, Wang Qiuke
Department of Orthopaedics, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Institute of Microsurgery on Extremities, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
BMJ Open. 2025 Jan 28;15(1):e087785. doi: 10.1136/bmjopen-2024-087785.
The infrapatellar fat pad and synovium are the sites of immune cell infiltration and the origin of proinflammation. Studies have shown that Hoffa's synovitis may be a sign of early-stage osteoarthritis (OA). However, there have been no effective interventions specifically for Hoffa's synovitis.
We will conduct a multicentre, multi-blind (participant, physician, outcome assessor and data analyst blinded) randomised controlled trial to compare the effectiveness of an intra-infrapatellar fat glucocorticoid versus an intra-articular injection for Hoffa's synovitis in patients with knee OA. We will recruit 236 knee OA patients with Hoffa's synovitis at outpatient clinics in three centres. We will randomly allocate them to two groups in a 1:1 ratio. One group will receive ultrasound-guided injection of 40 mg (1 mL) triamcinolone acetonide into the infrapatellar fat pad; the other group will receive ultrasound-guided injection of 40 mg (1 mL) triamcinolone acetonide into the knee joint cavity. All patients will be followed up at 2, 4, 8, 12 and 24 weeks after the injection. Primary outcomes are (1) Hoffa's synovitis improvement rate, measured with the MRI Osteoarthritis Knee Score system (superiority outcome) at 24 weeks and (2) pain intensity, measured with the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) at 2 weeks post-injection. Secondary outcomes include Hoffa's synovitis score at 2 weeks post-injection, pain intensity with the numerical rating scale, WOMAC questionnaire score improvements (function, joint stiffness and total score), improvement rates in effusion synovitis at 2 and 24 weeks, articular cartilage thickness changes at 2 and 24 weeks, Intermittent and Constant Osteoarthritis Pain score, quality of life measured with the EuroQol-5D, OARSI-OMERACT response indicators, co-interventions and side effects at 2, 4, 8, 12 and 24 weeks.
Ethical approval has been granted by the Medical Ethics Committee of the Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (2023-178). Written informed consent will be obtained from all patients prior to data collection. The findings of this research will be shared through presentations at academic conferences and publications in peer-reviewed journals.
ChiCTR2400080474.
髌下脂肪垫和滑膜是免疫细胞浸润的部位及促炎反应的起源。研究表明，霍法滑膜炎可能是早期骨关节炎（OA）的一个迹象。然而，目前尚无专门针对霍法滑膜炎的有效干预措施。
我们将进行一项多中心、多盲（参与者、医生、结果评估者和数据分析师均 blinded）随机对照试验，以比较髌下脂肪内注射糖皮质激素与关节腔内注射治疗膝关节 OA 患者霍法滑膜炎的有效性。我们将在三个中心的门诊招募 236 例患有霍法滑膜炎的膝关节 OA 患者。我们将以 1:1 的比例将他们随机分配到两组。一组将接受超声引导下向髌下脂肪垫注射 40mg（1mL）曲安奈德；另一组将接受超声引导下向膝关节腔注射 40mg（1mL）曲安奈德。所有患者将在注射后 2、4、8、12 和 24 周进行随访。主要结局指标为：（1）24 周时采用 MRI 膝关节骨关节炎评分系统测量的霍法滑膜炎改善率（优效性结局）；（2）注射后 2 周采用西安大略和麦克马斯特大学骨关节炎指数（WOMAC）测量的疼痛强度。次要结局指标包括注射后 2 周的霍法滑膜炎评分、采用数字评定量表的疼痛强度、WOMAC 问卷评分改善情况（功能、关节僵硬和总分）、2 周和 24 周时积液性滑膜炎的改善率、2 周和 24 周时关节软骨厚度变化、间歇性和持续性骨关节炎疼痛评分、采用欧洲五维健康量表测量的生活质量、OARSI-OMERACT 反应指标、2、4、8、12 和 24 周时的联合干预措施和副作用。
本研究已获得上海交通大学医学院附属上海第六人民医院医学伦理委员会的伦理批准（2023 - 178）。在数据收集前，将从所有患者处获得书面知情同意书。本研究的结果将通过在学术会议上报告及在同行评审期刊上发表的方式进行分享。
ChiCTR2400080474。
