单次补充透明质酸后的步态分析：一项前瞻性随机双盲对照试验。
Gait analysis following single-shot hyaluronic acid supplementation: a pilot randomized double-blinded controlled trial.
作者信息
Pereira Luis Carlos, Schweizer Claude, Moufarrij Sara, Krähenbühl Swenn M, Favre Julien, Gremion Gerald, Applegate Lee Ann, Jolles Brigitte M
机构信息
Centre Hospitalier Universitaire Vaudois (CHUV), Site Hôpital Orthopédique, Avenue Pierre Decker 4, CH-1011 Lausanne, Switzerland.
2Department of Musculoskeletal Medicine (DAL), University of Lausanne, Lausanne, Switzerland.
出版信息
Pilot Feasibility Stud. 2019 Apr 22;5:56. doi: 10.1186/s40814-019-0443-4. eCollection 2019.
OBJECTIVES
Viscosupplementation with new-generation, polyol-containing, cross-linked hyaluronic acid (HA) gels reduces joint inflammation in patients with knee osteoarthritis. Gait analysis is a complementary outcome measure to standard patient-reported scores and physical measures for testing the effect of HA injection. This three-arm, prospective, randomized, controlled, double-blind, feasibility pilot study investigated which gait parameters are more sensitive following a single bolus injection of polyol-containing HA for knee osteoarthritis.
METHODS
Twenty-two patients with Ahlbäck grade II-III knee osteoarthritis were randomly allocated into three groups: (1) HA + mannitol ( = 9), (2) HA + sorbitol ( = 5), and (3) saline placebo ( = 8). Patients were assessed by blinded observers prior to injection and at 4 weeks post-injection (4W). Outcome measures included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee Society score (KSS), EuroQol in five-dimensions (EQ-5D), VAS pain, and VAS stiffness. Gait was assessed over 30 m using a portable inertial-based data logger (Physilog®).
RESULTS
Differences between 4W and baseline were statistically significant for the mannitol-containing viscosupplement, with a median increase of 0.076 m/s on gait speed ( = 0.039), 0.055 m on stride length ( = 0.027), and 15 points on the KSS ( = 0.047). In contrast, the HA + sorbitol and saline groups demonstrated no significant changes from baseline to 4W in any gait parameters or self-reported outcome measures (all > 0.3). The observed increase in gait speed is approximately 13% greater than the mean difference between healthy subjects and those with knee osteoarthritis, is clinically important, and thus is a sensitive gait parameter.
CONCLUSIONS
This study demonstrated gait speed and stride length are the most relevant gait parameters to investigate when assessing the effect of polyol-containing HA viscosupplementation. This study supports the need for a larger, randomized, controlled, clinical trial to assess the effect of a single-bolus HA injection versus multiple injections in people with knee osteoarthritis using both gait performance and self-reported parameters of knee function.
TRIAL REGISTRATION
This study was retrospectively registered at clinicaltrials.gov on August 20, 2018, and assigned #NCT03636971.
LEVEL OF EVIDENCE
I.
目的
使用新一代含多元醇的交联透明质酸（HA）凝胶进行关节腔内注射补充治疗，可减轻膝骨关节炎患者的关节炎症。步态分析是一种辅助性结局指标，可补充标准的患者报告评分和物理测量方法，用于测试HA注射的效果。本三项分组、前瞻性、随机、对照、双盲可行性预试验研究，旨在探究单次大剂量注射含多元醇的HA治疗膝骨关节炎后，哪些步态参数更为敏感。
方法
22例Ahlbäck II-III级膝骨关节炎患者被随机分为三组：（1）HA+甘露醇组（n=9），（2）HA+山梨醇组（n=5），（3）生理盐水安慰剂组（n=8）。患者在注射前及注射后4周（4W）由盲法观察者进行评估。结局指标包括西安大略和麦克马斯特大学骨关节炎指数（WOMAC）、膝关节协会评分（KSS）、五维度欧洲生活质量量表（EQ-5D）、视觉模拟评分法疼痛评分（VAS疼痛）和视觉模拟评分法僵硬评分（VAS僵硬）。使用便携式惯性数据记录器（Physilog®）在30米距离内评估步态。
结果
含甘露醇的关节腔内注射补充治疗组在4W时与基线相比差异具有统计学意义，步态速度中位数增加0.076m/s（P=0.039），步幅长度增加0.055m（P=0.027），KSS增加15分（P=0.047）。相比之下，HA+山梨醇组和生理盐水组在任何步态参数或自我报告的结局指标方面，从基线到4W均未显示出显著变化（所有P>0.3）。观察到的步态速度增加比健康受试者与膝骨关节炎患者之间的平均差异大约高13%，具有临床意义，因此是一个敏感的步态参数。
结论
本研究表明在评估含多元醇的HA关节腔内注射补充治疗效果时，步态速度和步幅长度是最相关的步态参数。本研究支持开展一项更大规模的随机对照临床试验，以使用步态表现和膝关节功能的自我报告参数，评估单次大剂量HA注射与多次注射对膝骨关节炎患者的疗效。
试验注册
本研究于2018年8月20日在clinicaltrials.gov上进行回顾性注册，注册号为#NCT03636971。
证据级别
I级。
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