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临床试验/NCT03761472
NCT03761472已完成不适用

Comparison of Hyaluronic Acid and Platelet-rich Plasma Injection on Pain, Physical Function and Femoral Cartilage Thickness in Patients With Osteoarthritis

Bezmialem Vakif University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Change of numeric rating scale (rest, movement)

研究概览

简要总结

This study aims to compare the effects of hyaluronic acid injection and platelet rich plasma injection in terms of pain, physical function and femoral cartilage thickness in short term treatment in patients with knee osteoarthritis.

详细描述

Platelet-rich plasma and hyaluronic acid injections are both popular treatments and commonly used for treatment of knee osteoarthritis. Even though there are many studies investigating the effectiveness of these treatments, the results are mostly qualitative. Also there are a few studies comparing these two treatment modalities. In this study the investigators aim to compare these modalities both for self-reported data (pain, physical function) and objective measurement data (femoral cartilage thickness via ultrasonography). Patients with unilateral osteoarthritis/unilateral complaint will be included in the study. Unaffected side will be controls for each group.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject is able to consent
  • Subject meets Osteoarthritis Research Society International (OARSI) criteria for knee osteoarthritis
  • Subject has radiographic Kellgren-Lawrence grade 2-3 osteoarthritis
  • Unilateral osteoarthritis/complaint

排除标准

  • Past or actual knee infection
  • History of surgery, fracture on knee
  • Collagen tissue disease
  • Systemic inflammatory disease (rheumatoid arthritis, spondyloarthritis etc.)
  • Systemic diseases (diabetes, hematologic diseases, endocrinopathies, renal failure, liver failure)
  • Knee injection in past 6 months
  • Immunodeficiency
  • Pregnant/breastfeeding
  • Malignancy

结局指标

主要结局

Change of numeric rating scale (rest, movement)

时间窗: 0, 1st, 6th, months

Self reported pain scored between 0 (minimum)-10 (maximum). Higher scores represent a worse outcome.

Change of Western Ontario and McMaster Universities Osteoarthritis Index score(WOMAC)

时间窗: 0, 1st, 6th months

Self reported questionnaire investigating 24 daily living activities. Each item is scored 0-5 (0:none 5:worst). Yielding a total between 0-100. Higher scores represent a worse outcome.

Change of femoral cartilage thickness via ultrasonography.

时间窗: 0, 1st, 6th months

Transverse plane femoral cartilage thickness from three landmarks (from articular cartilage pothole,from midpoint of medial border and pothole of cartilage, from midpoint of lateral border and pothole of cartilage). Measured in millimeters. The sum of three points indicate a total thickness. A higher measurement indicates a thicker cartilage representing a better outcome.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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