Viscosupplementation in Patients With Hemophilic Arthropathy

Phase 4

Completed

• Conditions: Osteoarthritis; Hemarthrosis; Hemophilia A; Hemophilia B
• Interventions: Procedure: Joint lavage and viscosupplementation

• Registration Number: NCT01748201
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-12-06
• Study First Submitted QC: 2012-12-10
• Study First Posted: 2012-12-12
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-09
• Last Update Posted: 2013-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Joint lavage and viscosupplementation	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
SF-36	12 months	Evaluation of patient's quality of life using the quality of life's questionaire (SF-36)

Trial Locations

Locations (1)

Instituto de Ortopedia e Traumatologia HC-FMUSP; 🇧🇷 São Paulo, SP, Brazil