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Intra-articular Hyaluronic Acid in Mild to Moderate Knee Osteoarthritis

NCT01239810 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 34

Last updated 2010-12-09

No results posted yet for this study

Summary

Objective:

To assess the impact of intraarticular hyaluronic acid (HA) on clinical outcome and on volumetric and T2 relaxation based changes of articular cartilage in mild to moderate osteoarthritis (OA) of the knee joint.

Methods:

Patients with moderate OA of the knee \[Kellgren-Lawrence II\] were recruited for a 6-months prospective, randomized clinical trial evaluating the effect of HA on articular cartilage morphology and composition. Clinical examinations and MRI were performed at baseline, and after 6, 12 and 24 weeks. Cartilage volume, thickness and surface area were determined in cartilage plates and subregions were defined using proprietary software. MRI was performed on a 1.5 Tesla scanner; morphological evaluation was performed using 3D T1-w FLASH Waterexcitation (WE) sequences and T2 maps were calculated from a multiecho, spin-echo sequence.

Conditions

Interventions

DRUG

Hyaluronic Acid

Intraarticular injection 2ml Na-Hyaluronate (HA; MW 1.2 x 106; Ostenil, TRB Chemedica) weekly for five weeks

Sponsors & Collaborators

  • Technical University of Munich

    lead OTHER

Principal Investigators

  • Rüdiger von Eisenhart-Rothe, M.D. · Department of Orthopaedics and Traumatology, Technische Universität München

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2006-11-30
Completion
2008-12-31

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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 NCT01239810 on ClinicalTrials.gov