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
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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 |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Articular Lavage
Patients from Group Zero will receive articular lavage with saline injection
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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 |
- 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

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

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
Contact: Gustavo C de Campos, MD | +551983318000 | gustavoccampos@terra.com.br | |
Contact: Marcia U Rezende, PhD | +5511981226282 | murezende@uol.com.br |
Brazil | |
Instituto de Ortopedia e Traumatologia HC-FMUSP | Recruiting |
São Paulo, SP, Brazil, 05410-000 | |
Contact: Valquiria +551126616888 | |
Principal Investigator: Marcia U Rezende, Phd |
Principal Investigator: | Gustavo C de Campos, MD | FMUSP |
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 |
Osteoarthritis Hip Viscosupplementation Clinical Trial |
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Hylan |
Hyaluronic Acid Viscosupplements Protective Agents Physiological Effects of Drugs Adjuvants, Immunologic Immunologic Factors |