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Hip Viscosupplementation: What is the Best Dosage?

NCT01810809 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2013-09-11

No results posted yet for this study

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

Conditions

Interventions

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

DRUG

2 ampoules of Hylan GF-20

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

DRUG

3 ampoules of Hylan GF-20

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

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Gustavo C de Campos, MD · FMUSP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-06-30
Completion
2014-11-30

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01810809 on ClinicalTrials.gov