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Hip Viscosupplementation: What is the Best Dosage?

NCT ID: NCT01810809

Last Updated: 2013-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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

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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

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Osteoarthritis

Keywords

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Osteoarthritis Hip Viscosupplementation Clinical Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

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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

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

Eligibility Criteria

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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

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gustavo C de Campos, MD

Role: PRINCIPAL_INVESTIGATOR

FMUSP

Locations

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Instituto de Ortopedia e Traumatologia HC-FMUSP

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Gustavo C de Campos, MD

Role: CONTACT

Phone: +551983318000

Email: [email protected]

Marcia U Rezende, PhD

Role: CONTACT

Phone: +5511981226282

Email: [email protected]

Facility Contacts

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Valquiria

Role: primary

Other Identifiers

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0255/10

Identifier Type: -

Identifier Source: org_study_id