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

Primary Purpose

Osteoarthritis

Status

Unknown status

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

articular lavage with saline injection

1 ampoule of Hylan GF-20

2 ampoules of Hylan GF-20

3 ampoules of Hylan GF-20

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Hip, Viscosupplementation, Clinical Trial

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Instituto de Ortopedia e Traumatologia HC-FMUSPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Arm Label

Articular Lavage

Group 1

Group 2

Group 3

Arm Description

Patients from Group Zero will receive 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

Patients from Group 2 will receive articular lavage with saline injection and viscosupplementation with 4ml (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

Outcomes

Primary Outcome Measures

WOMAC

Pain and function assessment with WOMAC questionaire

VAS

Pain assessment with Visual Analogic Scale (VAS)

Lequesne

Pain and function assessment with Lequesne questionaire

Secondary Outcome Measures

Full Information

NCT ID

NCT01810809

First Posted

March 11, 2013

Last Updated

September 10, 2013

Sponsor

University of Sao Paulo General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01810809

Brief Title

Hip Viscosupplementation: What is the Best Dosage?

Acronym

Hip VS

Official Title

Hip Viscosupplementation: What is the Best Dosage?

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Unknown status

Study Start Date

April 2013 (undefined)

Primary Completion Date

June 2014 (Anticipated)

Study Completion Date

November 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

Keywords

Osteoarthritis, Hip, Viscosupplementation, Clinical Trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Articular Lavage

Arm Type

Active Comparator

Arm Description

Patients from Group Zero will receive articular lavage with saline injection

Arm Title

Group 1

Arm Type

Experimental

Arm Description

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

Arm Title

Group 2

Arm Type

Experimental

Arm Description

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

Arm Title

Group 3

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

articular lavage with saline injection

Intervention Description

Patients will receive articular lavage with saline injection

Intervention Type

Drug

Intervention Name(s)

1 ampoule of Hylan GF-20

Other Intervention Name(s)

1 ampole of Synvisc Classic

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

2 ampoules of Hylan GF-20

Other Intervention Name(s)

2 ampoles of Synvisc Classic

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

3 ampoules of Hylan GF-20

Other Intervention Name(s)

3 ampoules of Synvisc Classic

Intervention Description

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

Primary Outcome Measure Information:

Title

WOMAC

Description

Pain and function assessment with WOMAC questionaire

Time Frame

6 months

Title

VAS

Description

Pain assessment with Visual Analogic Scale (VAS)

Time Frame

6 months

Title

Lequesne

Description

Pain and function assessment with Lequesne questionaire

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gustavo C de Campos, MD

Phone

+551983318000

gustavoccampos@terra.com.br

First Name & Middle Initial & Last Name or Official Title & Degree

Marcia U Rezende, PhD

Phone

+5511981226282

murezende@uol.com.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gustavo C de Campos, MD

Organizational Affiliation

FMUSP

Official's Role

Principal Investigator

Facility Information:

Facility Name

Instituto de Ortopedia e Traumatologia HC-FMUSP

City

São Paulo

State/Province

ZIP/Postal Code

05410-000

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Valquiria

Phone

+551126616888

First Name & Middle Initial & Last Name & Degree

Marcia U Rezende, Phd

12. IPD Sharing Statement

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Hip Viscosupplementation: What is the Best Dosage?

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