Viscosupplementation in Patients With Hemophilic Arthropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01748201
First received: December 6, 2012
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Hemarthrosis
Hemophilia A
Hemophilia B
Procedure: Joint lavage and viscosupplementation
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Viscosupplementation in Patients With Hemophilic Arthropathy

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • WOMAC [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Evaluation of patient's symptoms using Western Ontario and McMaster Universities osteoarthritis index (WOMAC

  • VAS [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Visual analogic scale for pain assessment

  • Lequesne [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Evaluation of patient's symptoms using Lequesne questionaire


Secondary Outcome Measures:
  • SF-36 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Evaluation of patient's quality of life using the quality of life's questionaire (SF-36)


Enrollment: 13
Study Start Date: November 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: intra-articular injection

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748201

Locations
Brazil
Instituto de Ortopedia e Traumatologia HC-FMUSP
São Paulo, SP, Brazil, 05410-000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Marcia U Rezende, Phd FMUSP
  More Information

Additional Information:
No publications provided

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01748201     History of Changes
Other Study ID Numbers: 0199/11
Study First Received: December 6, 2012
Last Updated: September 9, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo General Hospital:
Osteoarthritis
Hemarthrosis
Hemophilia A
Hemophilia B
Viscosupplementation

Additional relevant MeSH terms:
Hemophilia B
Hemarthrosis
Hemophilia A
Joint Diseases
Osteoarthritis
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Musculoskeletal Diseases
Hemorrhage
Pathologic Processes
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 23, 2014