Intra-articular Hyaluronic Acid in Mild to Moderate Knee Osteoarthritis
Ostenil
Effect of Intra-articular Hyaluronic Acid on Articular Cartilage Morphology and Composition in Mild to Moderate Knee Osteoarthritis
1 other identifier
observational
34
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2005
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 9, 2010
CompletedFirst Posted
Study publicly available on registry
November 11, 2010
CompletedDecember 9, 2010
December 1, 2010
1.4 years
November 9, 2010
December 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
WOMAC
Western Ontario and McMaster University Osteoarthritis Index 24 weeks after drug adminstration
24 weeks
Secondary Outcomes (1)
MRI
24 weeks
Study Arms (2)
Control group
Receiving no treatment
hyaluronic acid
treatment group receiving intraarticular hyaluronic acid
Interventions
Intraarticular injection 2ml Na-Hyaluronate (HA; MW 1.2 x 106; Ostenil, TRB Chemedica) weekly for five weeks
Eligibility Criteria
referred from visiting orthopaedic surgeons to our academic outpatient clinic
You may qualify if:
- History of mild to moderate OA
- OA grade II
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rüdiger von Eisenhart-Rothe, M.D.
Department of Orthopaedics and Traumatology, Technische Universität München
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 9, 2010
First Posted
November 11, 2010
Study Start
June 1, 2005
Primary Completion
November 1, 2006
Study Completion
December 1, 2008
Last Updated
December 9, 2010
Record last verified: 2010-12