The Impact of Hyaluronic Acid Injections on Osteoarthritic Knee Mechanics

Phase 4

• Conditions: Osteoarthritis, Knee
• Interventions: Device: Hyaluronic acid; Device: Placebo (Saline injection)

• Registration Number: NCT00778076
• Lead Sponsor: University of Western Ontario, Canada

Brief 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.

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-10-22
• Study First Submitted QC: 2008-10-22
• Study First Posted: 2008-10-23
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-31
• Last Update Posted: 2009-04-01
• Primary Completion: 2009-05
• Study Completion: 2009-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HAG	Hyaluronic acid	Patients that will receive a Hyaluronic acid treatment course consisting of 3 consecutive injections one week apart.
PG	Placebo (Saline injection)	Those patients that receive 3 consecutive placebo injections one week apart.

Primary Outcome Measures

Name	Time	Method
Gait analysis with GAITRite software.	Baseline; after each injection; 3 and 6 months post treatment.

Secondary Outcome Measures

Name	Time	Method
WOMAC OA index (pain, stiffness, function); Six minute walk test (function).	Baseline; after each injection; 3 and 6 months post treatment.

Trial Locations

Locations (1)

St. Joseph's Health Care, Parkwood Hospital, Aging Rehabilitation and Geriatric Care research center; 🇨🇦 London, Ontario, Canada