We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Impact of Hyaluronic Acid Injections on Osteoarthritic Knee Mechanics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00778076
Recruitment Status : Unknown
Verified March 2009 by University of Western Ontario, Canada.
Recruitment status was:  Active, not recruiting
First Posted : October 23, 2008
Last Update Posted : April 1, 2009
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: Hyaluronic acid Device: Placebo (Saline injection) Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Biomechanical Impact of Intra-Articular Hyaluronic Acid in Knee Osteoarthritis Patients: A Randomized, Double Blind, Placebo Controlled Study
Study Start Date : July 2008
Estimated Primary Completion Date : May 2009
Estimated Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: HAG
Patients that will receive a Hyaluronic acid treatment course consisting of 3 consecutive injections one week apart.
Device: Hyaluronic acid
3 consecutive injections, each one week apart, of 20mg/2ml Hyaluronic acid.
Other Names:
  • Suplasyn
  • Sodium Hyaluronate
Placebo Comparator: PG
Those patients that receive 3 consecutive placebo injections one week apart.
Device: Placebo (Saline injection)
3 consecutive injections, each one week apart, of 20mg/2ml of Placebo.
Other Names:
  • Sham injection
  • Saline injection



Primary Outcome Measures :
  1. Gait analysis with GAITRite software. [ Time Frame: Baseline; after each injection; 3 and 6 months post treatment. ]

Secondary Outcome Measures :
  1. WOMAC OA index (pain, stiffness, function); Six minute walk test (function). [ Time Frame: Baseline; after each injection; 3 and 6 months post treatment. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00778076


Locations
Canada, Ontario
St. Joseph's Health Care, Parkwood Hospital, Aging Rehabilitation and Geriatric Care research center
London, Ontario, Canada, N6C 5J1
Sponsors and Collaborators
University of Western Ontario, Canada
Investigators
Principal Investigator: Robert J Petrella, MD, PhD University of Western Ontario, Canada
Study Director: Joseph E DeCaria, BA, MSc('09) University of Western Ontario, Canada

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Robert Petrella, The University of Western Ontario
ClinicalTrials.gov Identifier: NCT00778076     History of Changes
Other Study ID Numbers: REB#: 14017
First Posted: October 23, 2008    Key Record Dates
Last Update Posted: April 1, 2009
Last Verified: March 2009

Keywords provided by University of Western Ontario, Canada:
Knee OA, Hyaluronic acid, Gait, Pain, Synovial fluid

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents