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Additional Effects of Steroid and Dextrose to Hyaluronic Acid on Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
compare the effects of steroid plus hyaluronic acid and destrose plus hyaluronic acid on knee osteroarthritis
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, hyaluronic acid, steroid, dextrose

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • clinical diagnosis of knee osteoarthritis can walk for 15 meters Kellgren-Lawerence grade 2 or greater than 2 can follow up for 6 months

Exclusion Criteria:

  • major diseases will affect balance, such as stroke, infectious diseases, rheumatoid arthritis, dizziness, or vertigo fractures malignance pregnancy or prepare to pregnant received knee injections in the past 6 months previous operation of knee joints

Sites / Locations

  • Shin Kong Wu Ho-Su Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

steroid plus hyaluronic acid

dextrose plus hyaluronic acid

Arm Description

steroid plus hyaluronic acid injection, one time per week, for 3 weeks

dextrose plus hyaluronic acid injection, one time per week, for 3 weeks

Outcomes

Primary Outcome Measures

Western Ontario and McMaster Universities Osteoarthritis index
assess knee osteoarthritis related performance

Secondary Outcome Measures

Balance
Berg Balance scale
physical functional performance-walking
10 meters normal and fast walking speed
physical functional performance-stairs climbing
time for up and down stairs
physical functional performance-chair raising
5 repeated chair-rising time
physical functional performance-balance
timed up and go test
Knee Injury and Osteoarthritis Outcome Score
assess osteoarthritis of knee related function
Doppler resistance index
assess knee blood vessel resistance

Full Information

First Posted
November 10, 2019
Last Updated
November 17, 2019
Sponsor
Taipei Medical University
Collaborators
Shin Kong Wu Ho-Su Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04165902
Brief Title
Additional Effects of Steroid and Dextrose to Hyaluronic Acid on Knee Osteoarthritis
Official Title
Additional Therapeutic Effects of Triamcinolone to Hyaluronic Acid on Knee Osteoarthritis: a Double-blind, Randomized-controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 11, 2019 (Anticipated)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
July 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University
Collaborators
Shin Kong Wu Ho-Su Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Using double-blind, randomized controlled design to compare the immediate, short-term and intermediate-term additional therapeutic effects of ultrasound-guided corticosteroid injection and dextrose injection of hyaluronic acid injection on patients with knee osteoarthritis, under the basis of International Classification of Functioning, Disability, and Health.
Detailed Description
A total of 60 patients will be collected. The participants will be randomized into two groups, including hyaluronic acid combined corticosteroid group and hyaluronic acid combined dextrose group. The balance, physical activity (10 meters normal and fast walk, up and downstairs, and 5 repeated chair-rising time, timed up and go test), functional performance and knee-related quality of life (Western Ontario and McMaster Universities Osteoarthritis index、Knee Injury and Osteoarthritis Outcome Score) will be evaluated. All the evaluations will be re-evaluated at one week after injection, one month after injection, three months after injection, and six months after injection. Subjects and evaluators will be both blinded to the group's classification during the whole course of study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee osteoarthritis, hyaluronic acid, steroid, dextrose

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
steroid plus hyaluronic acid
Arm Type
Experimental
Arm Description
steroid plus hyaluronic acid injection, one time per week, for 3 weeks
Arm Title
dextrose plus hyaluronic acid
Arm Type
Active Comparator
Arm Description
dextrose plus hyaluronic acid injection, one time per week, for 3 weeks
Intervention Type
Drug
Intervention Name(s)
compare the effects of steroid plus hyaluronic acid and destrose plus hyaluronic acid on knee osteroarthritis
Intervention Description
compare the immediate effect (one week after 3 times of injections), short-term effects (one month and three months after 3 times of injections), and midterm effect (6 months after 3 times of injections).
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis index
Description
assess knee osteoarthritis related performance
Time Frame
changes of scores from baseline to at one week, one month, 3 months and 6 months after 3 times of injections; score range: 0-100, higher scores mean a worse outcome
Secondary Outcome Measure Information:
Title
Balance
Description
Berg Balance scale
Time Frame
changes of scores from baseling to at one week, one month, 3 months and 6 months after 3 times of injections; score range 0-4, higher scores mean a better outcome
Title
physical functional performance-walking
Description
10 meters normal and fast walking speed
Time Frame
change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
Title
physical functional performance-stairs climbing
Description
time for up and down stairs
Time Frame
change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
Title
physical functional performance-chair raising
Description
5 repeated chair-rising time
Time Frame
change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
Title
physical functional performance-balance
Description
timed up and go test
Time Frame
change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
Title
Knee Injury and Osteoarthritis Outcome Score
Description
assess osteoarthritis of knee related function
Time Frame
changes of scores from baseline to at one week, one month, 3 months and 6 months after 3 times of injections; score range 0-100, higher scores mean at better outcome
Title
Doppler resistance index
Description
assess knee blood vessel resistance
Time Frame
changes of scores from baseline to at one week after 1 time of injection and two weeks after 2 times of injection; the lower values indicate a low blood vessel resistance

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: clinical diagnosis of knee osteoarthritis can walk for 15 meters Kellgren-Lawerence grade 2 or greater than 2 can follow up for 6 months Exclusion Criteria: major diseases will affect balance, such as stroke, infectious diseases, rheumatoid arthritis, dizziness, or vertigo fractures malignance pregnancy or prepare to pregnant received knee injections in the past 6 months previous operation of knee joints
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ru-Lan Hsieh, MD
Phone
886-2984161201
Email
M001052@ms.skh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ru-Lan Hsieh, MD
Organizational Affiliation
Shin Kong Wu Ho-Su Memorial Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei
ZIP/Postal Code
111-01
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Additional Effects of Steroid and Dextrose to Hyaluronic Acid on Knee Osteoarthritis

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