Overview

This trial is active, not recruiting.

Condition osteoarthritis, knee
Treatments hyaluronic acid, placebo (saline injection)
Phase phase 4
Sponsor University of Western Ontario, Canada
Start date July 2008
End date May 2009
Trial size 30 participants
Trial identifier NCT00778076, REB#: 14017

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Patients that will receive a Hyaluronic acid treatment course consisting of 3 consecutive injections one week apart.
hyaluronic acid Suplasyn
3 consecutive injections, each one week apart, of 20mg/2ml Hyaluronic acid.
(Placebo Comparator)
Those patients that receive 3 consecutive placebo injections one week apart.
placebo (saline injection) Sham injection
3 consecutive injections, each one week apart, of 20mg/2ml of Placebo.

Primary Outcomes

Measure
Gait analysis with GAITRite software.
time frame: Baseline; after each injection; 3 and 6 months post treatment.

Secondary Outcomes

Measure
WOMAC OA index (pain, stiffness, function); Six minute walk test (function).
time frame: Baseline; after each injection; 3 and 6 months post treatment.

Eligibility Criteria

Male or female participants from 60 years up to 80 years old.

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.

Additional Information

Official title The Biomechanical Impact of Intra-Articular Hyaluronic Acid in Knee Osteoarthritis Patients: A Randomized, Double Blind, Placebo Controlled Study
Principal investigator Robert J Petrella, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2009.
Information provided to ClinicalTrials.gov by University of Western Ontario, Canada.