The Impact of Hyaluronic Acid Injections on Osteoarthritic Knee Mechanics
Recruitment status was Active, not recruiting
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Purpose
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 |
|---|---|---|
|
Osteoarthritis, Knee |
Device: Hyaluronic acid Device: Placebo (Saline injection) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Biomechanical Impact of Intra-Articular Hyaluronic Acid in Knee Osteoarthritis Patients: A Randomized, Double Blind, Placebo Controlled Study |
- Gait analysis with GAITRite software. [ Time Frame: Baseline; after each injection; 3 and 6 months post treatment. ] [ Designated as safety issue: No ]
- WOMAC OA index (pain, stiffness, function); Six minute walk test (function). [ Time Frame: Baseline; after each injection; 3 and 6 months post treatment. ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
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.
Other Names:
|
|
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.
Other Names:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 60 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 60 - 80 years old.
- Mild to moderate knee osteoarthritis:
- Clinical diagnosis (symptoms).
- Radiographic diagnosis (Kellgren-Lawrence grade I - III).
- Must provide provide informed consent and knowledge of all possible benefits and possible adverse events.
- Available for duration of the study.
- Not taking any other knee osteoarthritis medications during the study.
Exclusion Criteria:
- Non - OA arthritides.
- Hip, ankle, or foot OA.
- End stage OA.
- Lower back/extremity pathology.
- Previous surgery on knee affected by OA (except arthroscopy within the past 12 - 18 months).
- Neurological/Cardiovascular gait impairment.
- Pregnant.
- Cognitively impaired.
- Not available for duration of study.
- Taking other knee OA medications at time of study.
- Gastro-intestinal disturbance.
- Avian allergy or any other contraindication to intra-articular injections with Hyaluronic acid.
Contacts and Locations| Canada, Ontario | |
| 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 |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. Robert Petrella, The University of Western Ontario |
| ClinicalTrials.gov Identifier: | NCT00778076 History of Changes |
| Other Study ID Numbers: | REB#: 14017 |
| Study First Received: | October 22, 2008 |
| Last Updated: | March 31, 2009 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of Western Ontario, Canada:
|
Knee OA, Hyaluronic acid, Gait, Pain, Synovial fluid |
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 |
ClinicalTrials.gov processed this record on May 23, 2013