Intra-articular Hyaluronic Acid in Mild to Moderate Knee Osteoarthritis (Ostenil)

This study has been completed.
Sponsor:
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01239810
First received: November 9, 2010
Last updated: December 8, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Drug: Hyaluronic Acid
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Intra-articular Hyaluronic Acid on Articular Cartilage Morphology and Composition in Mild to Moderate Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • WOMAC [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Western Ontario and McMaster University Osteoarthritis Index 24 weeks after drug adminstration


Secondary Outcome Measures:
  • MRI [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    quantitative assessment of cartilage morphology using 3D T1-weighted FLASH Waterexcitation (WE) sequence following drug administration


Enrollment: 34
Study Start Date: June 2005
Study Completion Date: December 2008
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Control group
Receiving no treatment
Drug: Hyaluronic Acid
Intraarticular injection 2ml Na-Hyaluronate (HA; MW 1.2 x 106; Ostenil, TRB Chemedica) weekly for five weeks
Other Name: Ostenil
hyaluronic acid
treatment group receiving intraarticular hyaluronic acid
Drug: Hyaluronic Acid
Intraarticular injection 2ml Na-Hyaluronate (HA; MW 1.2 x 106; Ostenil, TRB Chemedica) weekly for five weeks
Other Name: Ostenil

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

referred from visiting orthopaedic surgeons to our academic outpatient clinic

Criteria

Inclusion Criteria:

  • History of mild to moderate OA
  • OA grade II

Exclusion Criteria:

  • Intraarticular injections in the affected knee
  • Oral application of glucosamine and chondroitin sulphate during the last 6 months prior to the beginning of the study
  • Clinically significant knee joint effusion
  • Neoplasm
  • Diabetes mellitus
  • Osteonecrosis
  • Rheumatoid arthritis or any other inflammatory arthritis diagnosed by American College of Rheumatology criteria.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01239810

Sponsors and Collaborators
Technische Universität München
Investigators
Principal Investigator: Rüdiger von Eisenhart-Rothe, M.D. Department of Orthopaedics and Traumatology, Technische Universität München
  More Information

No publications provided

Responsible Party: Dr. med. Dipl. Kfm. Rüdiger von Eisenhart-Rothe, Arbeitsgruppe Kinematik und Biomechanik Orthopädische Universitätsklinik Friedrichsheim Johann Wolfgang Goethe-Universität, Frankfurt
ClinicalTrials.gov Identifier: NCT01239810     History of Changes
Other Study ID Numbers: TBOSTZKM1
Study First Received: November 9, 2010
Last Updated: December 8, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität München:
hyaluronic acid
cartilage
T2 mapping
quantitative
MRI
volume

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on August 01, 2014