Hip Viscosupplementation: What is the Best Dosage?

Osteoarthritis Clinical Trial

— Hip VS  

Official title:

Hip Viscosupplementation: What is the Best Dosage?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01810809
• Other study ID #: 0255/10
• Status: Recruiting
• Phase: Phase 4
• First received: March 11, 2013
• Last updated: September 10, 2013
• Start date: April 2013
• Est. completion date: November 2014

Study information

• Verified date: September 2013
• Source: University of Sao Paulo General Hospital
• Contact: Gustavo C de Campos, MD
• Phone: +551983318000
• Email: gustavoccampos[@]terra.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• 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
• 2 ampoules of Hylan GF-20
Patients will receive viscosupplementation with 4ml (2 ampoules) of Hylan GF-20
• 3 ampoules of Hylan GF-20
Patients will receive viscosupplementation with 6ml (3 ampoules) of Hylan GF-20

Locations

Country	Name	City	State
Brazil	Instituto de Ortopedia e Traumatologia HC-FMUSP	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC	Pain and function assessment with WOMAC questionaire	6 months	No
Primary	VAS	Pain assessment with Visual Analogic Scale (VAS)	6 months	No
Primary	Lequesne	Pain and function assessment with Lequesne questionaire	6 months	No