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Post-Market Clinical Follow-up of Intra-Articular Hyaluronic Acid in Hip Osteoarthritis

2026年11月10日更新者：Meiji Pharma Spain S.A.

Clinical Follow-up Study of Patients With Hip Osteoarthritis Treated With Intra-Articular Hyaluronic Acid

The study population consists of approximately 40 adult outpatients aged 40 years or older with symptomatic hip osteoarthritis of at least 1 year of clinical evolution, treated with intra-articular hyaluronic acid in routine clinical practice within the Traumatology and Rehabilitation departments of participating hospitals in Spain.

研究概览

地位

招聘中

条件

髋骨关节炎

研究类型

观察性的

注册 (估计的)

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

西班牙
- - Madrid、西班牙
    - 招聘中
    - Hospital Universitario de La Princesa
    - 接触：
      
      Dr. J Del Río
      
      电话号码：+34 915 202 282
      
      邮箱：juliandel.rio@salud.madrid.org
    - 接触：
      
      Dr. MJ Arriaza
      
      电话号码：+34 915 20 22 00
      
      邮箱：mariajose.arriaza@salud.madrid.org
  - Madrid、西班牙
    - 招聘中
    - QuironSalud. Hospital Juan Bravo
    - 接触：
      
      Dr. J Del Río
      
      电话号码：+34 910 687 999
      
      邮箱：julian.delrio@quironsalud.es
  - Zaragoza、西班牙
    - 招聘中
    - Hospital Provincial Nuestra Señora de Gracia
    - 接触：
      
      Dr. A Santamaría
      
      电话号码：+34 976 44 00 22
      
      邮箱：asantamariato@salud.aragon.es

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Adult outpatients (>40 years) with symptomatic hip osteoarthritis (Kellgren-Lawrence II-III) receiving intra-articular hyaluronic acid.

描述

Inclusion Criteria:

Age: >40 years at the time of study inclusion
Preserved gait capability, with or without assistive devices
Symptomatic hip arthropathy with a disease evolution of at least 1 year.
Radiographic Kellgren-Lawrence grade II-III documented within the 12 months prior to study entry
Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score >15
Patient currently receiving intra-articular hyaluronic acid treatment within 3 months prior to study inclusion

Exclusion Criteria:

Refusal to provide written informed consent
Females who are pregnant, breastfeeding, or not using effective contraception
Body Mass Index (BMI) ≥ 30 kg/m²
Presence of other chronic or autoimmune diseases that could interfere with clinical evaluation
History of hypersensitivity or allergy to hyaluronic acid or its derivatives
Prior administration of intra-articular platelet-rich plasma (PRP) or intra-articular corticosteroids within 3 months, or intra-articular hyaluronic acid within 6 months prior to study entry

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：COHORT
时间观点：PROSPECTIVE

团体/队列数

队列和干预

团体/队列
Hyaluronic acid (HA) Patients with hip osteoarthritis treated with HA under real-world clinical practice conditions

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Change from Baseline in self-reported hip pain severityu as measured by Visual Analog Scale (VAS) Pain Score at 12 months 大体时间：Baseline (pre-treatment), 3 months and 12 months post-treatment	Assessment of patient-reported hip pain severity on a VAS, consisting of a 100mm horizontal line ranging from 0 mm (no pain) to 100 mm (worst imaginable pain). Higher scores indicate greater pain intensity; a negative change score reflects pain reduction.	Baseline (pre-treatment), 3 months and 12 months post-treatment

次要结果测量

结果测量	措施说明	大体时间
Change from Baseline in hip osteoarthritis symptoms as measured by WOMAC Osteoarthritis Index Total Score 大体时间：Baseline, Month 3, and Month 12	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) evaluating hip pain, stiffness, and physical function. Total score ranges from 0 to 96 points, where higher scores indicate worse symptom severity and greater physical disability.	Baseline, Month 3, and Month 12
Change from Baseline in hip joint function as measured by Modified Harris Hip Score (mHHS) 大体时间：Baseline, Month 3, and Month 12	Clinician- and patient-assessed standardized scale evaluating hip joint pain, gait, daily activities, and range of motion. Total score ranges from 0 to 100 points, where higher scores indicate superior hip joint function.	Baseline, Month 3, and Month 12
Change from Baseline in health-related quality of life as measured by the 12-Item Short Form Health Survey (SF-12) 大体时间：Baseline and Month 12	Assessment of physical and mental health-related quality of life dimensions using the 12-Item Short Form Health Survey (SF-12). Standardized scores range from 0 to 100 points, where higher scores represent better health-related quality of life.	Baseline and Month 12
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) 大体时间：From baseline up to Month 12	Percentage of participants experiencing adverse events and serious adverse events related or unrelated to intra-articular hyaluronic acid treatment throughout the follow-up period.	From baseline up to Month 12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Meiji Pharma Spain S.A.

合作者

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Quironsalud

Hospital Provincial Nuestra Señora de Gracia

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月29日

初级完成 (估计的)

2027年4月1日

研究完成 (估计的)

2027年4月1日

研究注册日期

首次提交

2026年9月25日

首先提交符合 QC 标准的

2026年10月13日

首次发布 (实际的)

2026年10月20日

研究记录更新

最后更新发布 (实际的)

2026年11月12日

上次提交的符合 QC 标准的更新

2026年11月10日

最后验证

2026年10月1日