The Impact of Hyaluronic Acid Injections on Osteoarthritic Knee Mechanics

Osteoarthritis, Knee Clinical Trial

Official title:

The Biomechanical Impact of Intra-Articular Hyaluronic Acid in Knee Osteoarthritis Patients: A Randomized, Double Blind, Placebo Controlled Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00778076
• Other study ID #: REB#: 14017
• Status: Active, not recruiting
• Phase: Phase 4
• First received: October 22, 2008
• Last updated: March 31, 2009
• Start date: July 2008
• Est. completion date: May 2009

Study information

• Verified date: March 2009
• Source: University of Western Ontario, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Hyaluronic acid
3 consecutive injections, each one week apart, of 20mg/2ml Hyaluronic acid.
• Placebo (Saline injection)
3 consecutive injections, each one week apart, of 20mg/2ml of Placebo.

Locations

Country	Name	City	State
Canada	St. Joseph's Health Care, Parkwood Hospital, Aging Rehabilitation and Geriatric Care research center	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait analysis with GAITRite software.		Baseline; after each injection; 3 and 6 months post treatment.	No
Secondary	WOMAC OA index (pain, stiffness, function); Six minute walk test (function).		Baseline; after each injection; 3 and 6 months post treatment.	No