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

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

Tracking Information

• First Submitted Date: March 11, 2013
• First Posted Date: March 14, 2013
• Last Update Posted Date: September 11, 2013
• Study Start Date: April 2013
• Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Hip Viscosupplementation: What is the Best Dosage?
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Osteoarthritis

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 11, 2013): 80
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2014
• Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT01810809
• Other Study ID Numbers: 0255/10
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Sao Paulo General Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Sao Paulo General Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Gustavo C de Campos, MD; FMUSP

• PRS Account: University of Sao Paulo General Hospital
• Verification Date: September 2013