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Efficacy and Safety of Repeated Intraarticular Injections of Hyaluronic Acid in Patients With OA of the Knee

NCT00669032 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 446

Last updated 2023-08-28

Study results available
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Summary

The main objective is the long-term comparison (3 years and 4 months) of the efficacy and safety of repeated intra-articular administration of hyaluronic acid in the treatment of osteoarthritis of the knee.

Conditions

  • Osteoarthritis of the Knee

Interventions

DEVICE

Hyaluronic acid

3 cycles of 5 hyaluronic acid injections, with a 6 month interval between each one. A 4th treatment cycle of five injections will be carried out at the end of one year

OTHER

Placebo

3 cycles of 5 saline solution injections, with a 6 month interval between each one. A 4th treatment cycle of five injections will be carried out at the end of one year

Sponsors & Collaborators

  • Tedec-Meiji Farma, S.A.

    lead INDUSTRY

Principal Investigators

  • Federico Navarro Sarabia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2009-07-31
Completion
2009-12-31

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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 NCT00669032 on ClinicalTrials.gov