Viscosupplementation in Patients With Hemophilic Arthropathy
Primary Purpose
Osteoarthritis, Hemarthrosis, Hemophilia A
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Joint lavage and viscosupplementation
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Hemarthrosis, Hemophilia A, Hemophilia B, Viscosupplementation
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).
Sites / Locations
- Instituto de Ortopedia e Traumatologia HC-FMUSP
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Joint lavage and viscosupplementation
Arm Description
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.
Outcomes
Primary Outcome Measures
WOMAC
Evaluation of patient's symptoms using Western Ontario and McMaster Universities osteoarthritis index (WOMAC
VAS
Visual analogic scale for pain assessment
Lequesne
Evaluation of patient's symptoms using Lequesne questionaire
Secondary Outcome Measures
SF-36
Evaluation of patient's quality of life using the quality of life's questionaire (SF-36)
Full Information
NCT ID
NCT01748201
First Posted
December 6, 2012
Last Updated
September 9, 2013
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01748201
Brief Title
Viscosupplementation in Patients With Hemophilic Arthropathy
Official Title
Viscosupplementation in Patients With Hemophilic Arthropathy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hemarthrosis, Hemophilia A, Hemophilia B
Keywords
Osteoarthritis, Hemarthrosis, Hemophilia A, Hemophilia B, Viscosupplementation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Joint lavage and viscosupplementation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Joint lavage and viscosupplementation
Other Intervention Name(s)
intra-articular injection
Intervention Description
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 Measure Information:
Title
WOMAC
Description
Evaluation of patient's symptoms using Western Ontario and McMaster Universities osteoarthritis index (WOMAC
Time Frame
12 months
Title
VAS
Description
Visual analogic scale for pain assessment
Time Frame
12 months
Title
Lequesne
Description
Evaluation of patient's symptoms using Lequesne questionaire
Time Frame
12 months
Secondary Outcome Measure Information:
Title
SF-36
Description
Evaluation of patient's quality of life using the quality of life's questionaire (SF-36)
Time Frame
12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcia U Rezende, Phd
Organizational Affiliation
FMUSP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Ortopedia e Traumatologia HC-FMUSP
City
São Paulo
State/Province
SP
ZIP/Postal Code
05410-000
Country
Brazil
12. IPD Sharing Statement
Links:
URL
http://sbot.org.br
Description
Brazilian Orthopaedics Association
URL
http://www.iothcfmusp.com.br
Description
Orthopaedics and Traumatology Institute website
Learn more about this trial
Viscosupplementation in Patients With Hemophilic Arthropathy
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