The Impact of Hyaluronic Acid Injections on Osteoarthritic Knee Mechanics
|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. ]
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|