The Impact of Hyaluronic Acid Injections on Osteoarthritic Knee Mechanics
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|ClinicalTrials.gov Identifier: NCT00778076|
Recruitment Status : Unknown
Verified March 2009 by University of Western Ontario, Canada.
Recruitment status was: Active, not recruiting
First Posted : October 23, 2008
Last Update Posted : April 1, 2009
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Device: Hyaluronic acid Device: Placebo (Saline injection)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Biomechanical Impact of Intra-Articular Hyaluronic Acid in Knee Osteoarthritis Patients: A Randomized, Double Blind, Placebo Controlled Study|
|Study Start Date :||July 2008|
|Estimated Primary Completion Date :||May 2009|
|Estimated Study Completion Date :||May 2009|
Active Comparator: HAG
Patients that will receive a Hyaluronic acid treatment course consisting of 3 consecutive injections one week apart.
Device: Hyaluronic acid
3 consecutive injections, each one week apart, of 20mg/2ml Hyaluronic acid.
Placebo Comparator: PG
Those patients that receive 3 consecutive placebo injections one week apart.
Device: Placebo (Saline injection)
3 consecutive injections, each one week apart, of 20mg/2ml of Placebo.
- Gait analysis with GAITRite software. [ Time Frame: Baseline; after each injection; 3 and 6 months post treatment. ]
- WOMAC OA index (pain, stiffness, function); Six minute walk test (function). [ Time Frame: Baseline; after each injection; 3 and 6 months post treatment. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00778076
|St. Joseph's Health Care, Parkwood Hospital, Aging Rehabilitation and Geriatric Care research center|
|London, Ontario, Canada, N6C 5J1|
|Principal Investigator:||Robert J Petrella, MD, PhD||University of Western Ontario, Canada|
|Study Director:||Joseph E DeCaria, BA, MSc('09)||University of Western Ontario, Canada|