A Phase 4 interventional study of Joint lavage and viscosupplementation in Osteoarthritis, Hemarthrosis and Hemophilia A, sponsored by University of Sao Paulo General Hospital. Completed at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2013-09-10.
Sponsored by University of Sao Paulo General Hospital · Phase 4, Interventional, and Treatment
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.
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.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's enrollment of 13 is below the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
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Exclusion Criteria:
The joint will be washed until obtaining translucent liquid and not hemorrhagic. Then it will receive an intra-articular injection of 6ml of hyaluronic acid (Synvisc One), 1ml of triamcinolone and 2 ml of ropivacaine.
Procedure: Joint lavage and viscosupplementation
The joint will be washed until obtaining translucent liquid and not hemorrhagic. Then it will receive an intra-articular injection of 6ml of hyaluronic acid (Synvisc One), 1ml of triamcinolone and 2 ml of ropivacaine.
Also known as: intra-articular injection
WOMAC
Evaluation of patient's symptoms using Western Ontario and McMaster Universities osteoarthritis index (WOMAC
Time frame: 12 months
VAS
Visual analogic scale for pain assessment
Time frame: 12 months
Lequesne
Evaluation of patient's symptoms using Lequesne questionaire
Time frame: 12 months
SF-36
Evaluation of patient's quality of life using the quality of life's questionaire (SF-36)
Time frame: 12 months
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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