Viscosupplementation in Patients With Hemophilic Arthropathy

Osteoarthritis Clinical Trial

Official title:

Viscosupplementation in Patients With Hemophilic Arthropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748201
• Other study ID #: 0199/11
• Status: Completed
• Phase: Phase 4
• First received: December 6, 2012
• Last updated: September 9, 2013
• Start date: November 2012
• Est. completion date: March 2013

Study information

• Verified date: September 2013
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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).

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemarthrosis
• Hemophilia A
• Hemophilia B
• Osteoarthritis

Intervention

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.

Locations

Country	Name	City	State
Brazil	Instituto de Ortopedia e Traumatologia HC-FMUSP	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC	Evaluation of patient's symptoms using Western Ontario and McMaster Universities osteoarthritis index (WOMAC	12 months	No
Primary	VAS	Visual analogic scale for pain assessment	12 months	No
Primary	Lequesne	Evaluation of patient's symptoms using Lequesne questionaire	12 months	No
Secondary	SF-36	Evaluation of patient's quality of life using the quality of life's questionaire (SF-36)	12 months	No

External Links

•   Brazilian Orthopaedics Association
•   Orthopaedics and Traumatology Institute website