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The Impact of Hyaluronic Acid Injections on Osteoarthritic Knee Mechanics

Primary Purpose

Osteoarthritis, Knee

Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Hyaluronic acid
Placebo (Saline injection)
Sponsored by
University of Western Ontario, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Knee OA, Hyaluronic acid, Gait, Pain, Synovial fluid

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

HAG

PG

Arm Description

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

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

Outcomes

Primary Outcome Measures

Gait analysis with GAITRite software.

Secondary Outcome Measures

WOMAC OA index (pain, stiffness, function); Six minute walk test (function).

Full Information

First Posted
October 22, 2008
Last Updated
March 31, 2009
Sponsor
University of Western Ontario, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT00778076
Brief Title
The Impact of Hyaluronic Acid Injections on Osteoarthritic Knee Mechanics
Official Title
The Biomechanical Impact of Intra-Articular Hyaluronic Acid in Knee Osteoarthritis Patients: A Randomized, Double Blind, Placebo Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
May 2009 (Anticipated)
Study Completion Date
May 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Western Ontario, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Knee OA, Hyaluronic acid, Gait, Pain, Synovial fluid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HAG
Arm Type
Active Comparator
Arm Description
Patients that will receive a Hyaluronic acid treatment course consisting of 3 consecutive injections one week apart.
Arm Title
PG
Arm Type
Placebo Comparator
Arm Description
Those patients that receive 3 consecutive placebo injections one week apart.
Intervention Type
Device
Intervention Name(s)
Hyaluronic acid
Other Intervention Name(s)
Suplasyn, Sodium Hyaluronate
Intervention Description
3 consecutive injections, each one week apart, of 20mg/2ml Hyaluronic acid.
Intervention Type
Device
Intervention Name(s)
Placebo (Saline injection)
Other Intervention Name(s)
Sham injection, Saline injection
Intervention Description
3 consecutive injections, each one week apart, of 20mg/2ml of Placebo.
Primary Outcome Measure Information:
Title
Gait analysis with GAITRite software.
Time Frame
Baseline; after each injection; 3 and 6 months post treatment.
Secondary Outcome Measure Information:
Title
WOMAC OA index (pain, stiffness, function); Six minute walk test (function).
Time Frame
Baseline; after each injection; 3 and 6 months post treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Petrella, MD, PhD
Organizational Affiliation
The University of Western Ontario
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph E DeCaria, BA, MSc('09)
Organizational Affiliation
The University of Western Ontario
Official's Role
Study Director
Facility Information:
Facility Name
St. Joseph's Health Care, Parkwood Hospital, Aging Rehabilitation and Geriatric Care research center
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 5J1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
15179649
Citation
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.
Results Reference
background
PubMed Identifier
22169699
Citation
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.
Results Reference
derived

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The Impact of Hyaluronic Acid Injections on Osteoarthritic Knee Mechanics

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