The Impact of Hyaluronic Acid Injections on Osteoarthritic Knee Mechanics

Study Overview
=================
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.

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

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Device: Hyaluronic acid
* Device: Placebo (Saline injection)


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HAG<br>Patients that will receive a Hyaluronic acid treatment course consisting of 3 consecutive injections one week apart. | Device: Hyaluronic acid<br>* 3 consecutive injections, each one week apart, of 20mg/2ml Hyaluronic acid.<br>* Other names: Sodium Hyaluronate;|
| Placebo Comparator: PG<br>Those patients that receive 3 consecutive placebo injections one week apart. | Device: Placebo (Saline injection)<br>* 3 consecutive injections, each one week apart, of 20mg/2ml of Placebo.<br>* Other names: Saline injection;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait analysis with GAITRite software. |  | Baseline; after each injection; 3 and 6 months post treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC OA index (pain, stiffness, function); Six minute walk test (function). |  | Baseline; after each injection; 3 and 6 months post treatment. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee OA, Hyaluronic acid, Gait, Pain, Synovial fluid