The Impact of Hyaluronic Acid Injections on Osteoarthritic Knee Mechanics

NCT ID: NCT00778076

Last Updated: 2009-04-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-05-31

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HAG

Patients that will receive a Hyaluronic acid treatment course consisting of 3 consecutive injections one week apart.

Group Type: ACTIVE_COMPARATOR

Hyaluronic acid

Intervention Type: DEVICE

3 consecutive injections, each one week apart, of 20mg/2ml Hyaluronic acid.

PG

Those patients that receive 3 consecutive placebo injections one week apart.

Group Type: PLACEBO_COMPARATOR

Placebo (Saline injection)

Intervention Type: DEVICE

3 consecutive injections, each one week apart, of 20mg/2ml of Placebo.

Interventions

Hyaluronic acid

3 consecutive injections, each one week apart, of 20mg/2ml Hyaluronic acid.

Intervention Type: DEVICE

Placebo (Saline injection)

3 consecutive injections, each one week apart, of 20mg/2ml of Placebo.

Intervention Type: DEVICE

Other Intervention Names

Suplasyn; Sodium Hyaluronate; Sham injection; Saline injection

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Western Ontario, Canada

OTHER

Sponsor Role: lead

Responsible Party

The University of Western Ontario

Principal Investigators

Robert J Petrella, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Western Ontario

Joseph E DeCaria, BA, MSc('09)

Role: STUDY_DIRECTOR

The University of Western Ontario

Locations

St. Joseph's Health Care, Parkwood Hospital, Aging Rehabilitation and Geriatric Care research center

London, Ontario, Canada

Countries

Canada

References

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. doi: 10.1016/j.apmr.2003.08.095.

Reference Type: BACKGROUND

PMID: 15179649 (View on PubMed)

DeCaria JE, Montero-Odasso M, Wolfe D, Chesworth BM, Petrella RJ. The effect of intra-articular hyaluronic acid treatment on gait velocity in older knee osteoarthritis patients: a randomized, controlled study. Arch Gerontol Geriatr. 2012 Sep-Oct;55(2):310-5. doi: 10.1016/j.archger.2011.11.007. Epub 2011 Dec 9.

Reference Type: DERIVED

PMID: 22169699 (View on PubMed)

Other Identifiers

REB#: 14017

Identifier Type: -

Identifier Source: org_study_id