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Efficacy and Safety of Intraarticular Sodium Hyaluronate Single Injection in Patients With Osteoarthritis of the Knee

NCT03852914 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2019-03-01

No results posted yet for this study

Summary

A Phase III, prospective, multicentre, non-controlled, with consecutive participant enrollment in order to evaluate the efficacy, safety and duration of the effects of the viscosupplementation with a preparation of sodium hyaluronate 2% (SH2%) from Tedec-Meiji Farma S.A. over 12 months. Adult patients diagnosed with primary osteoarthritis of the knee according to American College of Rheumatology (ACR) criteria with radiological grades II and III according to Kellgren-Lawrence scale (KL) will receive a single injection of SH2% and will be followed for 1 year with follow up visits at 6 and 12 months.

At 6 months patients could be offered a second injection whenever and when they comply with the criteria established for re-treatment and will be followed for additional 6 months

Conditions

  • Osteoarthritis, Knee

Interventions

DEVICE

Sodium hyaluronate 2%

Each patient will receive a single injection of SH 2% and will be followed for 6 months. At 6 months follow up visit patients could be offered a second injection whenever and when they comply with the criteria established for re-treatment and will be followed for additional 6 months.

Sponsors & Collaborators

  • Alpha Bioresearch S.L.

    collaborator OTHER

  • Tedec-Meiji Farma, S.A.

    lead INDUSTRY

Principal Investigators

  • Mercedes Gimeno, PhD · Tedec Meiji

  • Carlos Gavin, PhD · Hospital Uiversitario Fundacion Alcorcón

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-17
Primary Completion
2019-10-31
Completion
2020-04-30

Countries

  • Spain

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 NCT03852914 on ClinicalTrials.gov