Hip Viscosupplementation: What is the Best Dosage?

NCT ID: NCT01810809

Last Updated: 2013-09-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-11-30

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

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Articular Lavage

Patients from Group Zero will receive articular lavage with saline injection

Group Type: ACTIVE_COMPARATOR

articular lavage with saline injection

Intervention Type: PROCEDURE

Patients will receive articular lavage with saline injection

Group 1

Patients from Group 1 will receive articular lavage with saline injection and viscosupplementation with 2ml (1 ampoule) of Hylan GF-20

Group Type: EXPERIMENTAL

articular lavage with saline injection

Intervention Type: PROCEDURE

Patients will receive articular lavage with saline injection

1 ampoule of Hylan GF-20

Intervention Type: DRUG

Patients will receive viscosupplementation with 2ml (1 ampoule) of Hylan GF-20

Group 2

Patients from Group 2 will receive articular lavage with saline injection and viscosupplementation with 4ml (2 ampoules) of Hylan GF-20

Group Type: EXPERIMENTAL

articular lavage with saline injection

Intervention Type: PROCEDURE

Patients will receive articular lavage with saline injection

2 ampoules of Hylan GF-20

Intervention Type: DRUG

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

Group 3

Patients from Group 3 will receive articular lavage with saline injection and viscosupplementation with 6ml (3 ampoules) of Hylan GF-20

Group Type: EXPERIMENTAL

articular lavage with saline injection

Intervention Type: PROCEDURE

Patients will receive articular lavage with saline injection

3 ampoules of Hylan GF-20

Intervention Type: DRUG

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

Interventions

articular lavage with saline injection

Patients will receive articular lavage with saline injection

Intervention Type: PROCEDURE

1 ampoule of Hylan GF-20

Patients will receive viscosupplementation with 2ml (1 ampoule) of Hylan GF-20

Intervention Type: DRUG

2 ampoules of Hylan GF-20

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

Intervention Type: DRUG

3 ampoules of Hylan GF-20

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

Intervention Type: DRUG

Other Intervention Names

1 ampole of Synvisc Classic; 2 ampoles of Synvisc Classic; 3 ampoules of Synvisc Classic

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gustavo C de Campos, MD

Role: PRINCIPAL_INVESTIGATOR

FMUSP

Locations

Instituto de Ortopedia e Traumatologia HC-FMUSP

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Gustavo C de Campos, MD

Role: CONTACT

gustavoccampos@terra.com.br

+551983318000

Marcia U Rezende, PhD

Role: CONTACT

murezende@uol.com.br

+5511981226282

Facility Contacts

Valquiria

Role: primary

+551126616888

Other Identifiers

0255/10

Identifier Type: -

Identifier Source: org_study_id