NCT02063373

Brief Summary

Treatment: five intro-articular Hyaluronic Acid injection Assessment has two parts, that are as follow:

  1. 1.Postural stability and risk of fall assessment using Biodex stability index and "Timed up and Go" test
  2. 2.Gait and stair climbing assessment using Vicon motion capture system synchronized with four force plates.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at below P25 for phase_3

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
Last Updated

February 14, 2014

Status Verified

February 1, 2014

Enrollment Period

1.1 years

First QC Date

February 11, 2014

Last Update Submit

February 12, 2014

Conditions

Bilateral Knee Osteoarthritis

Outcome Measures

Primary Outcomes (3)

  • Change in Postural stability after treatment

    baseline and 6 weeks

  • Changes in Biomechanics of gait after treatment

    baseline and 6 weeks

  • Changes in biomechanics of stair climbing after treatment

    baseline and 6 weeks

Secondary Outcomes (2)

  • Change in Pain after treatment

    baseline and 6 weeks

  • Changes in WOMAC scores after treatment

    baseline and 6 weeks

Study Arms (1)

biomechanis knee OA and HA injection

EXPERIMENTAL

Weekly intra- articular Hyaluronic acid injection (20 MG/ 2 ML) into both knees for five weeks

Other: Hyaluronic acid

Interventions

Hyaluronic acidOTHER

treatment: Weekly intra-articular hyaluronic acid injection (20 MG / 2ML) into both knees for five weeks.

Also known as: Hyalgan, Manufacturer: Fidia Pharmaceutici S.p.A, Italy
biomechanis knee OA and HA injection

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mild and moderate bilateral knee osteoarthritis
  • Age between 50 and 70 years

You may not qualify if:

  • Recent Lower limb injury
  • Diabetic
  • Knee or hip replacement
  • Knees HA injection in last 6 months
  • Any neuromuscular disease such as stroke and Parkinson

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Khalaj N, Abu Osman NA, Mokhtar AH, George J, Abas WA. Effect of intra-articular hyaluronic injection on postural stability and risk of fall in patients with bilateral knee osteoarthritis. ScientificWorldJournal. 2014;2014:815184. doi: 10.1155/2014/815184. Epub 2014 Jun 19.

    PMID: 25136689DERIVED

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mrs

Study Record Dates

First Submitted

February 11, 2014

First Posted

February 14, 2014

Study Start

September 1, 2012

Primary Completion

October 1, 2013

Last Updated

February 14, 2014

Record last verified: 2014-02