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临床试验/NCT04852380
NCT04852380已完成不适用

Clinical Results Of Platelet Rich Plasma (PRP) Injections For Knee Osteoarthritis (KOA), Our Experience At Midterm Follow Up

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari1 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2018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
153
试验地点
1
主要终点
Change in Visual Analogic Scale

研究概览

简要总结

It was conducted a prospective study with a series of 153 patients treated with PRP injections in patient affected by knee osteoarthritis. One independent observer performed clinical and functional evaluations at T0 (recruitment), T1 (one month after the injection), T2 (three months after the last injection) and T3 (six months after the last injection).

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Knee Score Society (KSS) score and the Visual Analogue Scale (VAS) were evaluated and recorded for each patient at each follow up.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
40 Years 至 81 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 40 and 81;
  • Body mass index (BMI) between 21.5 and 29.3;
  • Chronic history (for at least 4 months) of knee joint pain;
  • Radiographically documented knee osteoarthritis of grades 1 to 3 (Kellgren-Lawrence (K-L) radiographic classification scale)

排除标准

  • Radiographically severe documented knee osteoarthritis of grade 4 (K-L radiographic classification scale);
  • Previous femur and tibia fractures;
  • Knee previous surgical treatment (e.g., arthroscopy);
  • Hyaluronic acid infiltration within the previous six months;
  • Hemoglobin levels <10 g/dL;
  • History of oncohematological disease, infections, or immunodepression

结局指标

主要结局

Change in Visual Analogic Scale

时间窗: Day 0; Month 1; Month 3; Month 6 (after the injection)

The knee pain was quantified using the Visual Analogic Scale ranging from 0 (no pain) to 10 (worst imaginable pain).

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 (1)

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