A Phase 4 interventional study of articular lavage with saline injection and 1 ampoule of Hylan GF-20 in Osteoarthritis, sponsored by University of Sao Paulo General Hospital. Status unknown at 1 site in Brazil. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2013-09-11.
Sponsored by University of Sao Paulo General Hospital · Phase 4, Interventional, and Treatment
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
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
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 80 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Patients from Group Zero will receive articular lavage with saline injection
Procedure: articular lavage with saline injection
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 · Drug: 1 ampoule of Hylan GF-20
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 · Drug: 2 ampoules of Hylan GF-20
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 · Drug: 3 ampoules of Hylan GF-20
Patients will receive articular lavage with saline injection
Patients will receive viscosupplementation with 2ml (1 ampoule) of Hylan GF-20
Also known as: 1 ampole of Synvisc Classic
Patients will receive viscosupplementation with 4ml (2 ampoules) of Hylan GF-20
Also known as: 2 ampoles of Synvisc Classic
Patients will receive viscosupplementation with 6ml (3 ampoules) of Hylan GF-20
Also known as: 3 ampoules of Synvisc Classic
WOMAC
Pain and function assessment with WOMAC questionaire
Time frame: 6 months
VAS
Pain assessment with Visual Analogic Scale (VAS)
Time frame: 6 months
Lequesne
Pain and function assessment with Lequesne questionaire
Time frame: 6 months
This study is status unknown, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo General Hospital