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

September 10, 2013 updated by: University of Sao Paulo General Hospital
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05410-000
        • Recruiting
        • Instituto de Ortopedia e Traumatologia HC-FMUSP
        • Contact:
          • Valquiria
          • Phone Number: +551126616888
        • Principal Investigator:
          • Marcia U Rezende, Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 3 ampoules of Synvisc Classic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC
Time Frame: 6 months
Pain and function assessment with WOMAC questionaire
6 months
VAS
Time Frame: 6 months
Pain assessment with Visual Analogic Scale (VAS)
6 months
Lequesne
Time Frame: 6 months
Pain and function assessment with Lequesne questionaire
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

November 1, 2014

Study Registration Dates

First Submitted

March 11, 2013

First Submitted That Met QC Criteria

March 11, 2013

First Posted (Estimate)

March 14, 2013

Study Record Updates

Last Update Posted (Estimate)

September 11, 2013

Last Update Submitted That Met QC Criteria

September 10, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0255/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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