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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

Tracking Information
First Submitted Date  ICMJE March 11, 2013
First Posted Date  ICMJE March 14, 2013
Last Update Posted Date September 11, 2013
Study Start Date  ICMJE April 2013
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2013)
  • WOMAC [ Time Frame: 6 months ]
    Pain and function assessment with WOMAC questionaire
  • VAS [ Time Frame: 6 months ]
    Pain assessment with Visual Analogic Scale (VAS)
  • Lequesne [ Time Frame: 6 months ]
    Pain and function assessment with Lequesne questionaire
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hip Viscosupplementation: What is the Best Dosage?
Official Title  ICMJE Hip Viscosupplementation: What is the Best Dosage?
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Articular Lavage
    Patients from Group Zero will receive articular lavage with saline injection
    Intervention: Procedure: 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
    Interventions:
    • Procedure: articular lavage with saline injection
    • Drug: 1 ampoule of Hylan GF-20
  • Experimental: Group 2
    Patients from Group 2 will receive articular lavage with saline injection and viscosupplementation with 4ml (2 ampoules) of Hylan GF-20
    Interventions:
    • Procedure: articular lavage with saline injection
    • Drug: 2 ampoules of Hylan GF-20
  • Experimental: Group 3
    Patients from Group 3 will receive articular lavage with saline injection and viscosupplementation with 6ml (3 ampoules) of Hylan GF-20
    Interventions:
    • Procedure: articular lavage with saline injection
    • Drug: 3 ampoules of Hylan GF-20
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 11, 2013)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2014
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01810809
Other Study ID Numbers  ICMJE 0255/10
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Sao Paulo General Hospital
Study Sponsor  ICMJE University of Sao Paulo General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gustavo C de Campos, MD FMUSP
PRS Account University of Sao Paulo General Hospital
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP