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Trial to Assess the Structural Effect and Long-term Symptomatic Relief of Intra-articular Injections of Hyaluronic Acid in Primary Knee OA

NCT02280538 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2014-11-03

No results posted yet for this study

Summary

The present study is designed to test the hypothesis that Intra-Articular Hyaluronic Acid (IAHA) is superior to placebo in slowing structural progression and on long term symptomatic effect in primary knee Osteoarthritis (OA) patients.

The investigators will perform a multicenter double-blind, randomized, placebo-controlled, parallel group trial.

Conditions

  • Osteoarthritis Of Knee

Interventions

DEVICE

Intra-Articular Hyaluronic Acid

DEVICE

Placebo

Sponsors & Collaborators

  • NOVA Medical School

    collaborator OTHER

  • Centro de Estudos de Doenças Crónicas

    collaborator OTHER

  • Hospital de Santa Maria, Portugal

    collaborator OTHER

  • Hospital de Egas Moniz

    collaborator OTHER

  • Instituto de Medicina Molecular João Lobo Antunes

    collaborator OTHER

  • Universidade Nova de Lisboa

    lead OTHER

Principal Investigators

  • Jaime C Branco, MD, PhD · CEDOC

  • Alexandre Sepriano, MD · Centro Hospitalar de Lisboa Ocidental

  • João Gomes, MD · Centro Hospitalar de Lisboa Ocidental

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • Portugal

Study Locations

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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 NCT02280538 on ClinicalTrials.gov