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临床试验/NCT03329235
NCT03329235已完成早期 1 期

Intraosseous With Intra-articular Injection of Platelet Rich Plasma Versus Hyaluronic Acid in Treatment of Knee Osteoarthritis

Cangzhou Central Hospital0 个研究点目标入组 86 人开始时间: 2015年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
86
主要终点
WOMAC scores

研究概览

简要总结

The aim of this study was to compare the efficacy of treatment in three groups of patients with knee osteoarthritis (OA) given a combination of intraosseous with intra-articular injection of platelet rich plasma (PRP), intra-articular injection of PRP and a single application of hyaluronic acid (HA).

详细描述

Methods Eighty-six patients from January 2015 to June 2015 with grade II to grade III knee osteoarthritis according to the Kellgren-Lawrence classification were randomly divided into 3 groups to receive either PRP or HA. Group A received intra-articular injection of PRP 2 ml combination with medial tibial plateau and medial femoral condyle injection of PRP 2 ml (once more 2 weeks later). Group B were treated with 2 ml of PRP intra-articular injection every 14 days for a total of two injections. Group C received intra-articular injection of hyaluronic acid 2 ml every 7 days for five injections. All patients were evaluated by the Visual Analogue Scale (VAS) and the Western Ontario and McMaster Universities (WOMAC) score before the treatment and at 1st, 3rd, 6th, 12th and 18th months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
40 Years 至 73 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Unilateral symptomatic knee with pain for at least 1 month or swelling.
  • Radiographic findings of knee degeneration (Kellgren-Lawrence score of II - III).
  • Age 40-73 years.
  • Body mass index (BMI) 18-32.5).
  • Knee stability without a severe trauma history.

排除标准

  • Bilateral knee osteoarthritis indicative of treatment for both knees.
  • Kellgren-Lawrence score greater than III.
  • Age >73 years.
  • Systemic autoimmune rheumatic diseases and blood disorders.
  • Active immunosuppressive or anticoagulant therapy.
  • Intra-articular injection to the knee within the previous 1 year or previous joint infection.
  • use of corticosteroids for 3 weeks before the procedure.
  • use of nonsteroidal anti-inflammatory drugs (NSAIDs) in the 3 weeks before treatment.

研究组 & 干预措施

Intraosseous and intra-articular

Experimental

injection of PRP 2 ml

干预措施: PRP (Drug)

intra-articular PRP

Active Comparator

injection PRP 2 ml

干预措施: PRP (Drug)

Intra-articular injection of HA

Active Comparator

injection of HA 2 ml

干预措施: HA (Drug)

结局指标

主要结局

WOMAC scores

时间窗: At the 18th month

The evaluation was performed with WOMAC, which were recorded on a five-point Likert scale scoring, with a response of "none" scored as 0, "mild" as 1, "moderate" as 2, "severe" as 3 and "extreme" as 4.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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