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Hip Viscosupplementation: What is the Best Dosage? (Hip VS)

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ClinicalTrials.gov Identifier: NCT01810809
Recruitment Status : Unknown
Verified September 2013 by University of Sao Paulo General Hospital.
Recruitment status was:  Recruiting
First Posted : March 14, 2013
Last Update Posted : September 11, 2013
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Study Description
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Brief Summary:
Intraarticular injections have long been used to treat osteoarthritis. Viscosupplementation is a relatively new approach comprising the injection of hyaluronic acid into diarthrodial joints. The dosis regimen is well established for the knee joint, but there is still no consensus regarding the optimal dosage for hip viscosupplementation. Our objective is to determine the optimal dosis for hip viscosupplementation

Condition or disease Intervention/treatment Phase
Osteoarthritis Procedure: articular lavage with saline injection Drug: 1 ampoule of Hylan GF-20 Drug: 2 ampoules of Hylan GF-20 Drug: 3 ampoules of Hylan GF-20 Phase 4

Detailed Description:
Intraarticular injections have long been used to treat osteoarthritis. Viscosupplementation is a relatively new approach comprising the injection of hyaluronic acid into diarthrodial joints. Any osteoarthritic joint is eligible to this treatment modality, but the great majority of studies are for knee viscosupplementation. The dosis regimen is well established for the knee joint, but there is still no consensus regarding the optimal dosage for hip viscosupplementation. We will prospectively enroll 80 patients with hip osteoarthritis and will randomize them into four groups: Group zero will receive joint lavage with saline injection. Group 1 will receive joint lavage with saline injection and 2 ml of Hylan GF-20 (1 ampoule of Synvisc Classic®). Group 2 will receive joint lavage with saline injection and 4 ml of Hylan GF-20 (2 ampoules of Synvisc Classic®). Group 3 will receive joint lavage with saline injection and 6 ml of Hylan GF-20 (3 ampoules of Synvisc Classic®). The Visual Analogic Scale of Pain (VAS), the Western Ontario and McMaster Universities Index (WOMAC®), and Lequesne questionnaires were completed at baseline and at Weeks 1, 4, 12, and 24. Our objective is to determine the optimal dosis for hip viscosupplementation
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hip Viscosupplementation: What is the Best Dosage?
Study Start Date : April 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Articular Lavage
Patients from Group Zero will receive articular lavage with saline injection
 Procedure: articular lavage with saline injection
Patients will receive articular lavage with saline injection
Experimental: Group 1
Patients from Group 1 will receive articular lavage with saline injection and viscosupplementation with 2ml (1 ampoule) of Hylan GF-20
 Procedure: articular lavage with saline injection
Patients will receive articular lavage with saline injection

Drug: 1 ampoule of Hylan GF-20
Patients will receive viscosupplementation with 2ml (1 ampoule) of Hylan GF-20
Other Name: 1 ampole of Synvisc Classic
Experimental: Group 2
Patients from Group 2 will receive articular lavage with saline injection and viscosupplementation with 4ml (2 ampoules) of Hylan GF-20
 Procedure: articular lavage with saline injection
Patients will receive articular lavage with saline injection

Drug: 2 ampoules of Hylan GF-20
Patients will receive viscosupplementation with 4ml (2 ampoules) of Hylan GF-20
Other Name: 2 ampoles of Synvisc Classic
Experimental: Group 3
Patients from Group 3 will receive articular lavage with saline injection and viscosupplementation with 6ml (3 ampoules) of Hylan GF-20
 Procedure: articular lavage with saline injection
Patients will receive articular lavage with saline injection

Drug: 3 ampoules of Hylan GF-20
Patients will receive viscosupplementation with 6ml (3 ampoules) of Hylan GF-20
Other Name: 3 ampoules of Synvisc Classic


Outcome Measures
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Primary Outcome Measures :
  1. WOMAC [ Time Frame: 6 months ]
    Pain and function assessment with WOMAC questionaire

  2. VAS [ Time Frame: 6 months ]
    Pain assessment with Visual Analogic Scale (VAS)

  3. Lequesne [ Time Frame: 6 months ]
    Pain and function assessment with Lequesne questionaire


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Met the American College of Rheumatology criteria for hip osteoarthritis
  • No hip intraarticular injections in the last 6 months

Exclusion Criteria:

- Severe reaction to the procedure

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810809


Contacts
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Contact: Gustavo C de Campos, MD +551983318000 gustavoccampos@terra.com.br
Contact: Marcia U Rezende, PhD +5511981226282 murezende@uol.com.br

Locations
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Brazil
Instituto de Ortopedia e Traumatologia HC-FMUSP Recruiting
São Paulo, SP, Brazil, 05410-000
Contact: Valquiria    +551126616888      
Principal Investigator: Marcia U Rezende, Phd         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Gustavo C de Campos, MD FMUSP
More Information
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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01810809    
Other Study ID Numbers: 0255/10
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: September 11, 2013
Last Verified: September 2013
Keywords provided by University of Sao Paulo General Hospital:
Osteoarthritis
Hip
Viscosupplementation
Clinical Trial
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hylan
 Hyaluronic Acid
Viscosupplements
Protective Agents
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors