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Sponsored by: |
University of Western Ontario, Canada |
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Information provided by: | University of Western Ontario, Canada |
ClinicalTrials.gov Identifier: | NCT00778076 |
The purpose of this study is to determine the impact of a regular course of treatment with Hyaluronic acid (HA) injections on gait in knee osteoarthritis (OA) patients. Three consecutive HA injections will be compared to three consecutive placebo injections to determine whether HA's analgesic effect is greater than that of a placebo injection, and to observe whether HA's viscoelastic properties are manifested in a human knee OA population. We hypothesize that HA injections will relieve pain to a greater extent than placebo injections in knee OA patients, and will afford them with improved walking characteristics, such as increased walking speed, and step length.
Condition | Intervention | Phase |
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Osteoarthritis, Knee |
Device: Hyaluronic acid Device: Placebo (Saline injection) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | The Biomechanical Impact of Intra-Articular Hyaluronic Acid in Knee Osteoarthritis Patients: A Randomized, Double Blind, Placebo Controlled Study |
Estimated Enrollment: | 30 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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HAG: Active Comparator
Patients that will receive a Hyaluronic acid treatment course consisting of 3 consecutive injections one week apart.
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Device: Hyaluronic acid
3 consecutive injections, each one week apart, of 20mg/2ml Hyaluronic acid.
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PG: Placebo Comparator
Those patients that receive 3 consecutive placebo injections one week apart.
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Device: Placebo (Saline injection)
3 consecutive injections, each one week apart, of 20mg/2ml of Placebo.
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Knee osteoarthritis (OA) is a severely debilitating disease associated with stiffness and pain in the knee joint, and with a loss of function. Hyaluronic acid (HA) injections are incorporated into non-surgical standard of care for knee OA patients and have been proven to relieve pain in patients who have not received symptomatic relief with other knee OA interventions. HA allows synovial fluid to act as a lubricant and shock absorber for joints, and although this is encouraging ground to advocate for the use of HA treatment in knee OA patients, these properties have yet to be proven in a controlled clinical trial setting. Therefore, we are undertaking this study to observe whether the physiological adaptation in the OA knee joint, initiated by HA injection, will result in biomechanical improvements in human knee OA patients, specifically walking mechanics.
Ages Eligible for Study: | 60 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Joseph DeCaria E DeCaria, BA, MSc('09) | (519) 639 - 6055 | jdecaria@uwo.ca |
Canada, Ontario | |
St. Joseph's Health Care, Parkwood Hospital, Aging Rehabilitation and Geriatric Care research center | Recruiting |
London, Ontario, Canada, N6C 5J1 | |
Contact: Bonita Stevenson (519) 685 - 4000 ext 42983 Bonita.Stevenson@sjhc.london.on.ca | |
Principal Investigator: Robert J Petrella, MD, PhD. |
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 |
Responsible Party: | The University of Western Ontario ( Dr. Robert Petrella ) |
Study ID Numbers: | REB#: 14017 |
Study First Received: | October 22, 2008 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00778076 |
Health Authority: | Canada: Health Canada |
Knee OA, Hyaluronic acid, Gait, Pain, Synovial fluid |
Osteoarthritis, Knee Musculoskeletal Diseases Hyaluronic Acid Osteoarthritis |
Joint Diseases Arthritis Pain Rheumatic Diseases |
Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic Pharmacologic Actions |