Clinical trial NCT01748201: Viscosupplementation in Patients With Hemophilic Arthropathy
Official title: Viscosupplementation in Patients With Hemophilic Arthropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Hemarthrosis
Hemophilia A
Hemophilia B
Keywords: Osteoarthritis
Hemarthrosis
Hemophilia A
Hemophilia B
Viscosupplementation
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2012-12-12
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: WOMAC
timeFrame: 12 months
measure: VAS
timeFrame: 12 months
measure: Lequesne
timeFrame: 12 months
Secondary outcomes:
measure: SF-36
timeFrame: 12 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto de Ortopedia e Traumatologia HC-FMUSP
state: SP
Study officials:
affiliation: FMUSP
name: Marcia U Rezende, Phd
role: PRINCIPAL_INVESTIGATOR
References: