The Impact of Hyaluronic Acid Injections on Osteoarthritic Knee Mechanics - Full Text View

Sponsored by:	University of Western Ontario, Canada
Information provided by:	University of Western Ontario, Canada
ClinicalTrials.gov Identifier:	NCT00778076

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 IV

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Sodium chloride Hyaluronate Sodium Hyaluronic acid

U.S. FDA Resources

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

Further study details as provided by University of Western Ontario, Canada:

Primary Outcome Measures:

Gait analysis with GAITRite software. [ Time Frame: Baseline; after each injection; 3 and 6 months post treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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
HAG: Active Comparator 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.
PG: Placebo Comparator 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.

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778076

Contacts

Contact: Joseph DeCaria E DeCaria, BA, MSc('09)

(519) 639 - 6055

jdecaria@uwo.ca

Locations

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.

Sponsors and Collaborators

University of Western Ontario, Canada

Investigators

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:

Tang SF, Chen CP, Chen MJ, Pei YC, Lau YC, Leong CP. Changes in sagittal ground reaction forces after intra-articular hyaluronate injections for knee osteoarthritis. Arch Phys Med Rehabil. 2004 Jun;85(6):951-5.

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

Keywords provided by University of Western Ontario, Canada:

Knee OA, Hyaluronic acid, Gait, Pain, Synovial fluid

Study placed in the following topic categories:

Osteoarthritis, Knee
Musculoskeletal Diseases
Hyaluronic Acid
Osteoarthritis

Joint Diseases
Arthritis
Pain
Rheumatic Diseases

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009