Viscosupplementation in Patients With Hemophilic Arthropathy

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.

Study Overview

• Status: Completed
• Conditions: Hemophilia A; Hemophilia B; Osteoarthritis; Hemarthrosis
• Intervention / Treatment: Procedure: Joint lavage and viscosupplementation

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05410-000
      • Instituto de Ortopedia e Traumatologia HC-FMUSP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: intra-articular injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-36	Evaluation of patient's quality of life using the quality of life's questionaire (SF-36)	12 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Marcia U Rezende, Phd, FMUSP

Publications and helpful links

Helpful Links

• Brazilian Orthopaedics Association
• Orthopaedics and Traumatology Institute website

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: December 6, 2012
• First Submitted That Met QC Criteria: December 10, 2012
• First Posted (Estimate): December 12, 2012

Study Record Updates

• Last Update Posted (Estimate): September 10, 2013
• Last Update Submitted That Met QC Criteria: September 9, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Osteoarthritis; Hemophilia B; Viscosupplementation; Hemophilia A; Hemarthrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Hematologic Diseases; Hemorrhage; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Blood Coagulation Disorders; Hemophilia A; Hemophilia B; Osteoarthritis; Joint Diseases; Hemarthrosis
• Other Study ID Numbers: 0199/11