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临床试验/NCT02601170
NCT02601170已完成不适用

Platelet-Rich Plasma Intra-Articular Injection in Treating Hemophilic Arthropathy

Tri-Service General Hospital0 个研究点目标入组 22 人开始时间: 2014年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
22
主要终点
Pain (Visual Analogue Scale) and Change From Baseline at 1, 2, 3 &6 Months

研究概览

简要总结

Severe hemophilia is characterized by frequent and lifelong bleeding, with more than 60% of bleeds occurring into joints . Repeated joint bleeding leads to chronic synovitis, cartilage damage and bony destruction. Currently available treatment of hemophilic arthropathy, such as analgesics, NSAIDs, and hyaluronic acid (HA), are predominantly directed toward the symptomatic relief of pain and inflammation, but they do little to reduce joint cartilage degeneration.

Platelet-Rich Plasma (PRP) is a simple and minimally invasive method that provides a natural concentrate of autologous growth factors from the blood. This method is now being increasingly applied in clinical practice to treat musculoskeletal disorders, such as tendon repairment and osteoarthritis. To the best of our knowledge, no study applies PRP for arthropathy of knee joint in hemophilia patients. The aim of the study is to investigate the efficacy, safety and duration of benefit of single PRP injection versus five weekly intra-articular injections of HA in patients with hemophilic arthropathy of knee.

详细描述

Severe haemophilia is characterized by frequent and lifelong bleeding, with more than 60% of bleeds occurring into joints. Repeated joint bleeding leads to chronic synovitis, cartilage damage and bony destruction, which are associated with limitation of range of motion (ROM), pain, muscle atrophy, functional impairment, and poor quality of life. The knee, elbow, and ankle are the most commonly involved joints and arthropathy could worsen in adolescence or young adulthood. Hemophilic arthropathy is a multifactorial event and there is evidence to suggest that iron may play a major role with release of cytokines such as Interleukin ( IL)-1, IL-6, and tumour necrosis factor alpha (TNF-α) leading to chronic proliferative synovitis, hypervascularity, and progressive arthropathy. These effects on cartilage and subchondral bone are inflammatory and degenerative in nature and management of chronic hemophilic arthropathy is difficult.

Currently available drugs for the treatment of hemophilic arthropathy, such as analgesics, corticosteroids, nonsteroid and steroid anti-inflammatory drugs, and hyaluronic acid (HA), are predominantly directed toward the symptomatic relief of pain and inflammation, but they do little to reduce joint cartilage degeneration.

Platelet Rich Plasma (PRP) is a simple and minimally invasive method that provides a natural concentrate of autologous growth factors from the blood. This method is now being increasingly applied in clinical practice to treat musculoskeletal disorders, such as tendon repairment and osteoarthritis. Growth factors including platelet derived growth factor (PDGF), insulin growth factor (IGF), vascular endothelial growth factor, and transforming growth factor beta-1 are believed to be key components of PRP for structural repair. Although comparing PRP with other intra-articular and soft tissue injections has led to conflicting results, it seems that PRP has useful effects on healing and functional improvement of injured tissues. To the best of our knowledge, only one study applies PRP for arthropathy in haemophilia. Teyssler et al reported PRP could reduce pain of chronic ankle synovitis in hemophilia although the small sample size (n=6), short term follow-up and absence of a control group.

Hyaluronic acid (HA) has some role in joint mechanical support and its metabolic effects, which causes endogenous HA synthesis, stimulation of chondrocyte metabolism, synthesis of cartilage matrix components, and inhibition of chondrodegenerative enzymes, as well as inflammatory process. In 1994 Fernandez-Palazzi et al firstly used intra-articular HA injection for haemophiliacs with arthropathy and reported its beneficial effects in 2002. Recently, Carulli et al reported 27 haemophilic patients with a mean seven-year follow-up who had excellent results in terms of pain relief and functional improvement in the knee following treatment with HA injection. Viscosupplementation is a safe and effective therapeutic strategy in haemophilic arthropathy of knee in order to delay of surgery.

The aim of the study was to investigate the efficacy, safety and duration of benefit of single PRP injection versus five weekly intra-articular injections of HA in patients with haemophilic arthropathy of knee.

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
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • hemophilia patients with hemophilic arthropathy of knee joints for at least 6 months
  • painful (VAS ≥ 3) hemophilic arthropathy of knee joints after medication

排除标准

  • presence of joint infections, any surgery on the joint in preceding 12 months
  • intra-articular corticosteroid or HA injection within the past 6 months
  • treatment with systemic steroids
  • history of rheumatoid arthritis, or gouty arthropathy
  • history of chicken or egg allergy
  • presence of neoplasm
  • use of non steroidal anti-inflammatory drugs in the 5 days before study
  • platelet values < 100,000/mm3
  • acute hemarthrosis
  • paresis, or recent trauma.

研究组 & 干预措施

PRP Group

Experimental

single intra-articular injection of 2mL PRP (RegentKit-THT-1, RegenLab SA, Mont-sur-Lausanne, Switzerland)

干预措施: Platelet-Rich Plasma Intra-Articular Injection (Biological)

HA Group

Active Comparator

five weekly intra-articular injections of 2.5 mL of hyaluronate sodium (ARTZDispo, Seikagaku Corporation Japan).

干预措施: Hyaluronic Acid Viscosupplementation (Drug)

结局指标

主要结局

Pain (Visual Analogue Scale) and Change From Baseline at 1, 2, 3 &6 Months

时间窗: baseline, 1 month, 2 months, 3 months, 6 months

The pain intensity will be evaluated subjectively on a visual analogue scale (0-10). Higher scores mean a worse outcome.

次要结局

  • Ultrasonographic Synovial Thickness (mm) and Change From Baseline at 1, 2, 3 &6 Months(baseline, 1 month, 2 months, 3 months, 6 months)
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) From Baseline at 1, 2, 3 &6 Months(baseline, 1 month, 2 months, 3 months, 6 months)
  • Short Form-36 (SF-36) From Baseline at 1, 2, 3 &6 Months(baseline, 1 month, 2 months, 3 months, 6 months)
  • Range of Motion (ROM, Degrees) From Baseline at 1, 2, 3 &6 Months(baseline, 1 month, 2 months, 3 months, 6 months)
  • Hemarthrosis From Baseline at 1, 2, 3 &6 Months(baseline, 1 month, 2 months, 3 months, 6 months)
  • Synovial Hyperemia (Score) and Change From Baseline at 1, 2, 3 &6 Months(baseline, 1 month, 2 months, 3 months, 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tsung-Ying Li

Attending physician

Tri-Service General Hospital

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