Clinical Trial: Viscosupplementation in Patients With Hemophilic Arthropathy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Viscosupplementation in Patients With Hemophilic Arthropathy

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: University of Sao Paulo General Hospital

Current Primary Outcome:

  • WOMAC [ Time Frame: 12 months ]
    Evaluation of patient's symptoms using Western Ontario and McMaster Universities osteoarthritis index (WOMAC
  • VAS [ Time Frame: 12 months ]
    Visual analogic scale for pain assessment
  • Lequesne [ Time Frame: 12 months ]
    Evaluation of patient's symptoms using Lequesne questionaire


Original Primary Outcome: Same as current

Current Secondary Outcome: SF-36 [ Time Frame: 12 months ]

Evaluation of patient's quality of life using the quality of life's questionaire (SF-36)


Original Secondary Outcome: Same as current

Information By: University of Sao Paulo General Hospital

Dates:
Date Received: December 6, 2012
Date Started: November 2012
Date Completion:
Last Updated: September 9, 2013
Last Verified: September 2013