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Effects of Knee Injections on Patients With Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis, Injection, Effect of Drug

Status

Enrolling by invitation

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

Triamcinolone plus hyruan

vitagen plus hyruan

normal saline plus hyruan

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, steroid, hyaluronic acid, 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-Lawrence grade 2 or greater
can follow up for 6 months

Exclusion Criteria:

Major diseases will affect balance, such as stroke
infectious disease,
rheumatoid arthritis,
malignancy
pregnancy or prepare to pregnant
received knee injections in the past 6 months
previous knee operation history

Sites / Locations

Shin Kong Wu Ho-Su Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Study group

Experimental

Placebo

Arm Description

triamcinolone plus hyruan injection

vitagen plus hyruan injection

normal saline plus hyruan injection

Outcomes

Primary Outcome Measures

Western Ontario and McMaster Universities Osteoarthritis index

assess knee related performance, scores: 0-100, higher score indicates a worse outcome

Secondary Outcome Measures

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 rising

time for 5 repeated chair-rising time

physical functional performance-balance

time for up and go test

Knee Injury and Osteoarthritis Outcome Score

assess knee osteoarthritis related function, scores: 0-100, higher score indicates a better outcome

Full Information

NCT ID

NCT05220527

First Posted

January 5, 2022

Last Updated

January 20, 2022

Sponsor

Taipei Medical University

Collaborators

Shin Kong Wu Ho-Su Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05220527

Brief Title

Effects of Knee Injections on Patients With Knee Osteoarthritis

Official Title

Therapeutic Effects of Knee Intra-articular Injections on Patients With Knee Osteoarthritis: a Double-blind, Randomized, Placebo-controlled Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Enrolling by invitation

Study Start Date

August 1, 2020 (Actual)

Primary Completion Date

July 31, 2022 (Anticipated)

Study Completion Date

July 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Using a double-blind, randomized, placebo-controlled design to compare the immediate, short-term, and intermediate-term additional therapeutic effects of ultrasound-guided corticosteroid injection and dextrose injection to 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 three groups, including the hyaluronic acid combined corticosteroid group, hyaluronic acid combined dextrose group, and hyaluronic acid combined normal saline group (placebo group). The functional performance and knee-related quality of life (Western Ontario and McMaster Universities Osteoarthritis index、Knee Injury and Osteoarthritis Outcome Score), pain (pressure threshold by pain pressure ergometer), and physical activity (10 meters normal and fast walk, up and downstairs, 5 repeated chair-rising time, timed up and go test) and image progression by high-resolution ultrasound will be evaluated before treatment, one week after injections, one month after injections, three months after injections, and six months after injections. Participants and evaluators will be both blinded to the group's allocation during the whole course of intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis, Injection, Effect of Drug

Keywords

knee osteoarthritis, steroid, hyaluronic acid, dextrose

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Study group

Arm Type

Experimental

Arm Description

triamcinolone plus hyruan injection

Arm Title

Experimental

Arm Type

Active Comparator

Arm Description

vitagen plus hyruan injection

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

normal saline plus hyruan injection

Intervention Type

Drug

Intervention Name(s)

Triamcinolone plus hyruan

Other Intervention Name(s)

corticosteroids plus hyaluronic acid

Intervention Description

triamcinolone plus hyruan injections, one time per week, for 3 weeks

Intervention Type

Drug

Intervention Name(s)

vitagen plus hyruan

Other Intervention Name(s)

dextrose plus hyaluronic acid

Intervention Description

vitagen plus hyruan injections, one time per week, for 3 weeks

Intervention Type

Drug

Intervention Name(s)

normal saline plus hyruan

Other Intervention Name(s)

normal saline plus hyaluronic acid

Intervention Description

normal saline plus hyruan injections, one time per week, for 3 weeks

Primary Outcome Measure Information:

Title

Western Ontario and McMaster Universities Osteoarthritis index

Description

assess knee related performance, scores: 0-100, higher score indicates a worse outcome

Time Frame

changes of scores from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections

Secondary Outcome Measure Information:

Title

physical functional performance-walking

Description

10 meters normal and fast walking speed

Time Frame

changes of time (seconds) 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

changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections

Title

physical functional performance-chair rising

Description

time for 5 repeated chair-rising time

Time Frame

changes of time (seconds) from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections

Title

physical functional performance-balance

Description

time for up and go test

Time Frame

changes of time (seconds) 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 knee osteoarthritis related function, scores: 0-100, higher score indicates a better outcome

Time Frame

changes of scores from baseline to at one week, one month, 3 months, and 6 months after 3 times of injections

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: clinical diagnosis of knee osteoarthritis can walk for 15 meters Kellgren-Lawrence grade 2 or greater can follow up for 6 months Exclusion Criteria: Major diseases will affect balance, such as stroke infectious disease, rheumatoid arthritis, malignancy pregnancy or prepare to pregnant received knee injections in the past 6 months previous knee operation history

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

Yes

IPD Sharing Plan Description

By request, the data will be shared with other researchers.

IPD Sharing Time Frame

The data will become available after publication and for one year since publication.

IPD Sharing Access Criteria

Request by mail to the investigator.

Learn more about this trial

Effects of Knee Injections on Patients With Knee Osteoarthritis

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