Viscosupplementation in Patients With Hemophilic Arthropathy
1 other identifier
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Nov 2012
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 6, 2012
CompletedFirst Posted
Study publicly available on registry
December 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedSeptember 10, 2013
September 1, 2013
4 months
December 6, 2012
September 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
SF-36
12 months
Study Arms (1)
Joint lavage and viscosupplementation
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- patients with hemophilia A or B;
- symptomatic arthropathy;
You may not qualify if:
- inadequate follow-up;
- Bleeding elsewhere as to not allow for functional evaluation;
- complications of Arthrocentesis (infection).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto de Ortopedia e Traumatologia HC-FMUSP
São Paulo, São Paulo, 05410-000, Brazil
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcia U Rezende, Phd
FMUSP
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2012
First Posted
December 12, 2012
Study Start
November 1, 2012
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
September 10, 2013
Record last verified: 2013-09