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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02063373
Other study ID # UM/MOHE/HIR D000010-16001
Secondary ID
Status Completed
Phase Phase 3
First received February 11, 2014
Last updated February 12, 2014
Start date September 2012

Study information

Verified date February 2014
Source University of Malaya
Contact n/a
Is FDA regulated No
Health authority Malaysia: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Treatment: five intro-articular Hyaluronic Acid injection

Assessment has two parts, that are as follow:

1. Postural stability and risk of fall assessment using Biodex stability index and "Timed up and Go" test

2. Gait and stair climbing assessment using Vicon motion capture system synchronized with four force plates.

For knee OA subjects, assessment was done in week one or before injection; and for healthy controls one assessment was performed.


Description:

This study aimed to assess the effect of hyaluronic acid injection on Postural stability, biomechanics of gait and stair climbing in individuals with bilateral knee osteoarthritis (OA).

Participants were individuals with knee OA (control and treatment) and healthy people.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date
Est. primary completion date October 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 50 Years to 70 Years
Eligibility Inclusion Criteria:

- Mild and moderate bilateral knee osteoarthritis

- Age between 50 and 70 years

Exclusion Criteria:

- Recent Lower limb injury

- Diabetic

- Knee or hip replacement

- Knees HA injection in last 6 months

- Any neuromuscular disease such as stroke and Parkinson

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Malaya

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Postural stability after treatment baseline and 6 weeks No
Primary Changes in Biomechanics of gait after treatment baseline and 6 weeks No
Primary Changes in biomechanics of stair climbing after treatment baseline and 6 weeks No
Secondary Change in Pain after treatment baseline and 6 weeks No
Secondary Changes in WOMAC scores after treatment baseline and 6 weeks No
See also
  Status Clinical Trial Phase
Recruiting NCT04975165 - Comparison of Gait Pattern Between Simultaneous and Staged Knee Arthroplasties N/A
Recruiting NCT04567732 - Bilateral Knee Osteoarthritis: Intra-articular Injection of Filtered Autologous Adipose Tissue Versus Placebo N/A
Completed NCT03378076 - Study to Compare Exposure of TA Following Administration of Either FX006 or TAcs in Patients With Bilateral Knee OA Phase 2