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临床试验/NCT01748201
NCT01748201已完成4 期

Viscosupplementation in Patients With Hemophilic Arthropathy

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
13
试验地点
2
主要终点
WOMAC

研究概览

简要总结

Hemophilia is a recessive X chromosome linked genetic disorder of blood coagulation that affects about one in every ten thousand people. Hemarthrosis, which you can begin in childhood, promptly leads to degenerative changes of the articular cartilage which culminate in deformity and degenerative changes early, known as hemophilic arthropathy, which is the most common complication of hemophilia. Aside administration of clotting factor, treatment should address the degenerative changes already present in patients joints. Our objective is to evaluate the effectiveness of articular washing followed by infiltration with corticosteroids and hylan G-F 20, followed by a program of home exercises and/or academy as the previous level of hemophilia patients, in relation to pain relief, and improved function and quality of life.

详细描述

Hemophilia is a recessive X chromosome linked genetic disorder of blood coagulation that affects about one in every ten thousand people. There are two main types of hemophilia. Hemophilia A or classical hemophilia corresponds to 80% of the cases, and is caused by a deficiency or change of factor VIII. Hemophilia B is caused by deficiency or amendment of factor IX, and represents about 20%. Patients with hemophilia type A or B have the same clinical presentation. Cases with moderate or severe hemophilia exhibit a tendency to spontaneous bleeding or after minimal trauma, being the joints the most frequent sites of hemorrhage. The joints most commonly affected are the knees, followed by the elbows, ankles, shoulders and hips. Hemarthrosis, which you can begin in childhood, promptly leads to degenerative changes of the articular cartilage which culminate in deformity and degenerative changes early, known as hemophilic arthropathy, which is the most common complication of hemophilia. The hemophilic arthropathy is highly debilitating and consumes a large amount of resources for the treatment of hemophilic patients. Currently, by the adequate administration of the clotting factor, the hemophilic patient has a life expectancy of next to normal. Therefore other forms of treatment must be researched; they can be palliative or modifiers of the natural history of disease, to try to postpone the need for arthroplasty . Our objective is to evaluate the effectiveness of treatment, consisting of articular washing followed by infiltration with corticosteroids and hylan G-F 20, followed by a program of home exercises and/or academy as the previous level of hemophilia patients, in relation to pain relief, and improved function and quality of life.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • patients with hemophilia A or B;
  • symptomatic arthropathy;

排除标准

  • inadequate follow-up;
  • Bleeding elsewhere as to not allow for functional evaluation;
  • complications of Arthrocentesis (infection).

结局指标

主要结局

WOMAC

时间窗: 12 months

Evaluation of patient's symptoms using Western Ontario and McMaster Universities osteoarthritis index (WOMAC

VAS

时间窗: 12 months

Visual analogic scale for pain assessment

Lequesne

时间窗: 12 months

Evaluation of patient's symptoms using Lequesne questionaire

次要结局

  • SF-36(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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