Department of Radiology and Nuclear Medicine, Erasmus Medical Center, Rotterdam, Zuid-Holland, Netherlands
Department of Orthopaedics and Sports Medicine, Erasmus Medical Center, Rotterdam, Zuid-Holland, Netherlands.
BMJ Open. 2024 Oct 1;14(10):e087047. doi: 10.1136/bmjopen-2024-087047.
To determine the efficacy of genicular artery embolisation (GAE) compared with sham GAE for pain reduction in patients with symptomatic mild-to-moderate knee osteoarthritis (KOA).
Double-blind randomised sham-controlled clinical trial conducted from June 2019 to December 2021. The follow-up period was 4 months.
Single-centre study conducted at a university medical centre in Rotterdam, Netherlands.
58 adults with symptomatic mild-to-moderate KOA not improving with conservative treatment.
Participants were randomised to receive either GAE treatment or a sham GAE treatment.
The primary outcome was reduction of pain measured with the Knee Injury and Osteoarthritis Outcome Score pain subscale (0-100, with 0 representing the worst pain outcome and 100 the best) after 4 months. Outcomes were assessed at baseline and 1 and 4 months.
From June 2019 to December 2021, 58 patients were included. 29 patients were randomised to the GAE group and 29 to the sham group. All participants completed the study. The mean pain reduction after 4 months was 21.4 (95% CI 13.9 to 28.8) for the GAE group and 18.4 points (95% CI 11.6 to 25.1) for the sham group. The between-group difference for the mean pain reduction was 3.0 (95% CI -7.1 to 13.0) with an estimated Cohen's d effect size of d = 0.15 (95% CI -0.37 to 0.66). Group allocation was not a significant contributor to pain reduction (p = 0.31). No serious adverse events (AEs) occurred. 23 mild AEs occurred in the GAE group and 5 in the sham group.
We did not establish a clinical effect of GAE in patients with mild-to-moderate KOA as GAE produced a similar effect on pain reduction as a sham GAE procedure.
NCT03884049.
比较内侧膝下动脉栓塞术（GAE）与假 GAE 治疗对有症状的轻中度膝骨关节炎（KOA）患者疼痛缓解的疗效。
2019 年 6 月至 2021 年 12 月进行的双盲随机假对照临床试验。随访期为 4 个月。
荷兰鹿特丹大学医学中心的单中心研究。
58 名接受保守治疗后症状仍未改善的有症状的轻中度 KOA 成人。
参与者被随机分配接受 GAE 治疗或假 GAE 治疗。
主要结局是在 4 个月后用膝关节损伤和骨关节炎结果评分疼痛子量表（0-100，0 代表最差的疼痛结果，100 代表最好的疼痛结果）衡量的疼痛减轻程度。在基线、1 个月和 4 个月时进行评估。
2019 年 6 月至 2021 年 12 月，共纳入 58 名患者。29 名患者被随机分配到 GAE 组，29 名患者被随机分配到假 GAE 组。所有参与者均完成了研究。GAE 组 4 个月后疼痛平均缓解 21.4 分（95%CI 13.9 至 28.8），假 GAE 组为 18.4 分（95%CI 11.6 至 25.1）。两组间平均疼痛缓解的差异为 3.0 分（95%CI -7.1 至 13.0），估计 Cohen's d 效应量为 d=0.15（95%CI -0.37 至 0.66）。组分配对疼痛缓解没有显著影响（p=0.31）。无严重不良事件（AE）发生。GAE 组发生 23 例轻度 AE，假 GAE 组发生 5 例。
我们没有发现 GAE 对轻中度 KOA 患者疼痛缓解有临床效果，因为 GAE 与假 GAE 手术对疼痛缓解的效果相似。
NCT03884049。
