Olympic Park Sports Medicine Centre, 60 Olympic Blvd, Melbourne, 3004, Australia.
School of Medicine, Deakin University, Little Malop St, Geelong, Victoria, 3220, Australia.
BMC Musculoskelet Disord. 2021 Sep 16;22(1):797. doi: 10.1186/s12891-021-04672-0.
Osteoarthritis (OA) is the most prevalent form of joint disease and commonly affects the hip. Hip OA is associated with a high socioeconomic burden. Intra-articular hyaluronic acid (HA) injection may be of benefit but quality evidence for HA use in hip OA is lacking. The purpose of this study was to assess the safety and efficacy of ultrasound guided injection of a high molecular weight, non-animal derived, stabilised HA (NASHA) in patients with mild to moderate hip OA.
This single site study is an analysis of prospectively collected outcome data for 87 consecutive patients over a 2-year period who received a single HA (Durolane) injection for symptomatic hip OA. Inclusion criteria were male or female patients over 18-years of age with mild to moderate hip OA on x-ray. Patients with severe hip OA were excluded. The primary outcome measure was a modified Harris Hip Score (mHHS) questionnaire at baseline and 6-weeks with a minimal clinically important difference (MCID) of 10 points. All adverse events were recorded and assessed.
Data from 87 patients, 49 women and 38 men with mean age of 54 (SD = 10.8) were analysed. At baseline, mean mHHS was 58.47 (SD 14.31). At the 6 week follow up, mean mHHS improved to 71.30 (SD 16.46), a difference of 12.83 (p < 0.01). This was greater than the MCID of 10. No significant adverse events were encountered. Five patients reported short-lived injection site pain.
A single injection of HA (NASHA) in the setting of hip joint OA was both safe and efficacious in this 87 patient cohort. Improvement in pain and function as measured with mHHS was statistically significant and reached the MCID of 10.
The study was retrospectively registered on the 1st of February 2021 in the Australian New Zealand Clinical Trials Registry with registry number ACTRN12621000098831 . All research was performed in accordance with the Declaration of Helsinki.
骨关节炎（OA）是最常见的关节疾病，通常影响髋关节。髋 OA 与高社会经济负担有关。关节内透明质酸（HA）注射可能有益，但缺乏 HA 在髋 OA 中应用的高质量证据。本研究旨在评估超声引导下注射高分子量、非动物源性、稳定化 HA（NASHA）治疗轻度至中度髋 OA 患者的安全性和疗效。
这是一项单中心研究，对 2 年内 87 例连续接受 HA（Durolane）治疗的症状性髋 OA 患者的前瞻性收集的结果数据进行了分析。纳入标准为年龄在 18 岁以上的男性或女性 X 线轻度至中度髋 OA 患者。排除严重髋 OA 患者。主要结局测量是基线和 6 周时改良 Harris 髋关节评分（mHHS）问卷，最小临床重要差异（MCID）为 10 分。记录并评估所有不良事件。
共分析了 87 例患者的数据，其中 49 例为女性，38 例为男性，平均年龄为 54（SD=10.8）岁。基线时，平均 mHHS 为 58.47（SD 14.31）。6 周随访时，mHHS 平均提高至 71.30（SD 16.46），差异为 12.83（p<0.01）。这大于 10 的 MCID。未发现明显不良事件。5 例患者报告短暂的注射部位疼痛。
在髋关节 OA 患者中单次注射 HA（NASHA）既安全又有效。mHHS 测量的疼痛和功能改善具有统计学意义，并达到了 10 的 MCID。
该研究于 2021 年 2 月 1 日在澳大利亚和新西兰临床试验注册中心进行了回顾性注册，注册号为 ACTRN12621000098831。所有研究均符合赫尔辛基宣言。
