The Impact of Hyaluronic Acid Injections on Osteoarthriti... | NCT00778076

Studies
The Impact of Hyaluronic Acid Injections on Osteoarthritic Knee Mechanics

NCT00778076

Sponsor

University of Western Ontario, Canada

Status

Unknown status

Last Update Posted

Apr 1, 2009Estimated

Enrollment

30Estimated

Phase

Phase 4

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic acid
Placebo (Saline injection)

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

May 2009Estimated

Completion Date

May 2009Estimated

First Submitted Date

Oct 22, 2008

First Submission Date that Met QC Criteria

Oct 22, 2008

First Posted Date

Oct 23, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2009

Last Update Posted Date

Apr 1, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HAG	Active Comparator	Patients that will receive a Hyaluronic acid treatment course consisting of 3 consecutive injections one week apart.	Device: Hyaluronic acid
PG	Placebo Comparator	Those patients that receive 3 consecutive placebo injections one week apart.	Device: Placebo (Saline injection)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hyaluronic acid	Device	3 consecutive injections, each one week apart, of 20mg/2ml Hyaluronic acid.	HAG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gait analysis with GAITRite software.		Baseline; after each injection; 3 and 6 months post treatment.

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert J Petrella, MD, PhD	The University of Western Ontario	Principal Investigator
Joseph E DeCaria, BA, MSc('09)	The University of Western Ontario	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Joseph's Health Care, Parkwood Hospital, Aging Rehabilitation and Geriatric Care research center		London	Ontario	N6C 5J1	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15179649	Background	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.
22169699	Derived	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.

ID	Term
D020370	Osteoarthritis, Knee
D010146	Pain

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases