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CompletedNCT01748201Updated Sep 10, 2013

Viscosupplementation in Patients With Hemophilic Arthropathy

A Phase 4 interventional study of Joint lavage and viscosupplementation in Osteoarthritis, Hemarthrosis and Hemophilia A, sponsored by University of Sao Paulo General Hospital. Completed at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2013-09-10.

Sponsored by University of Sao Paulo General Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Osteoarthritis
  • Hemarthrosis
  • Hemophilia A
  • Hemophilia B

Keywords

  • Osteoarthritis
  • Hemarthrosis
  • Hemophilia A
  • Hemophilia B
  • Viscosupplementation
03

In context

Osteoarthritis

2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.

This study's enrollment of 13 is below the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

University of Sao Paulo General Hospital is the lead sponsor of 611 studies on the registry; 98 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients with hemophilia A or B;
  • symptomatic arthropathy;

Exclusion criteria

Exclusion Criteria:

  • inadequate follow-up;
  • Bleeding elsewhere as to not allow for functional evaluation;
  • complications of Arthrocentesis (infection).
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureJoint 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.

    Also known as: intra-articular injection

06

What researchers measure

Primary outcomes

  1. WOMAC

    Evaluation of patient's symptoms using Western Ontario and McMaster Universities osteoarthritis index (WOMAC

    Time frame: 12 months

  2. VAS

    Visual analogic scale for pain assessment

    Time frame: 12 months

  3. Lequesne

    Evaluation of patient's symptoms using Lequesne questionaire

    Time frame: 12 months

Secondary outcomes

  1. SF-36

    Evaluation of patient's quality of life using the quality of life's questionaire (SF-36)

    Time frame: 12 months

07

Study locations

1 site
  • Instituto de Ortopedia e Traumatologia HC-FMUSP
    São Paulo, SP 05410-000, Brazil
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01748201
Responsible party
Sponsor
First posted
Dec 12, 2012
Start date
Nov 2012
Primary completion
Mar 2013
Completion
Mar 2013
Last update
Sep 10, 2013

Study contacts

Marcia U Rezende, Phd
principal investigator · FMUSP

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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