The Impact of Hyaluronic Acid Injections on Osteoarthritic Knee Mechanics

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by University of Western Ontario, Canada.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Western Ontario, Canada
ClinicalTrials.gov Identifier:
NCT00778076
First received: October 22, 2008
Last updated: March 31, 2009
Last verified: March 2009
  Purpose

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 Intervention Phase
Osteoarthritis, Knee
Device: Hyaluronic acid
Device: Placebo (Saline injection)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Western Ontario, Canada:

Primary Outcome Measures:
  • Gait analysis with GAITRite software. [ Time Frame: Baseline; after each injection; 3 and 6 months post treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • WOMAC OA index (pain, stiffness, function); Six minute walk test (function). [ Time Frame: Baseline; after each injection; 3 and 6 months post treatment. ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2008
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Additional 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
Study First Received: October 22, 2008
Last Updated: March 31, 2009
Health Authority: Canada: Health Canada

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014