NCT00778076

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

April 1, 2009

Status Verified

March 1, 2009

Enrollment Period

10 months

First QC Date

October 22, 2008

Last Update Submit

March 31, 2009

Conditions

Osteoarthritis, Knee

Keywords

Knee OA, Hyaluronic acid, Gait, Pain, Synovial fluid

Outcome Measures

Primary Outcomes (1)

  • Gait analysis with GAITRite software.

    Baseline; after each injection; 3 and 6 months post treatment.

Secondary Outcomes (1)

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

    Baseline; after each injection; 3 and 6 months post treatment.

Study Arms (2)

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

Hyaluronic acidDEVICE

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

Also known as: Suplasyn, Sodium Hyaluronate
HAG
Placebo (Saline injection)DEVICE

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

Also known as: Sham injection, Saline injection
PG

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

London, Ontario, N6C 5J1, Canada

Location

Related Publications (2)

  • 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.

    PMID: 15179649BACKGROUND

  • 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.

    PMID: 22169699DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneePain

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 22, 2008

First Posted

October 23, 2008

Study Start

July 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

April 1, 2009

Record last verified: 2009-03

Locations

CA(1)