- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04165902
Additional Effects of Steroid and Dextrose to Hyaluronic Acid on Knee Osteoarthritis
November 17, 2019 updated by: Ru-Lan Hsieh, Taipei Medical University
Additional Therapeutic Effects of Triamcinolone to Hyaluronic Acid on Knee Osteoarthritis: a Double-blind, Randomized-controlled Clinical Trial
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ru-Lan Hsieh, MD
- Phone Number: 886-2984161201
- Email: M001052@ms.skh.org.tw
Study Locations
-
-
-
Taipei, Taiwan, 111-01
- Shin Kong Wu Ho-Su Memorial Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: steroid plus hyaluronic acid
steroid plus hyaluronic acid injection, one time per week, for 3 weeks
|
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).
|
Active Comparator: dextrose plus hyaluronic acid
dextrose plus hyaluronic acid injection, one time per week, for 3 weeks
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Western Ontario and McMaster Universities Osteoarthritis index
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
|
assess knee osteoarthritis related performance
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Balance
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
|
Berg Balance scale
|
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
|
physical functional performance-walking
Time Frame: change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
|
10 meters normal and fast walking speed
|
change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
|
physical functional performance-stairs climbing
Time Frame: change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
|
time for up and down stairs
|
change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
|
physical functional performance-chair raising
Time Frame: change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
|
5 repeated chair-rising time
|
change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
|
physical functional performance-balance
Time Frame: change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
|
timed up and go test
|
change from baseline to at one week, one month, 3 months and 6 months after 3 times of injections
|
Knee Injury and Osteoarthritis Outcome Score
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
|
assess osteoarthritis of knee related function
|
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
|
Doppler resistance index
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
|
assess knee blood vessel resistance
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Ru-Lan Hsieh, MD, Shin Kong Wu Ho-Su Memorial Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 11, 2019
Primary Completion (Anticipated)
July 31, 2020
Study Completion (Anticipated)
July 31, 2020
Study Registration Dates
First Submitted
November 10, 2019
First Submitted That Met QC Criteria
November 13, 2019
First Posted (Actual)
November 18, 2019
Study Record Updates
Last Update Posted (Actual)
November 19, 2019
Last Update Submitted That Met QC Criteria
November 17, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOST 108-2314-B-341-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Knee Osteoarthritis
-
LifeBridge HealthMicroPort Orthopedics Inc.; Rubin Institute for Advanced OrthopedicsRecruitingKnee Osteoarthritis | Osteoarthritis, Knee | Knee Pain Chronic | Arthropathy of Knee Joint | Knee Disease | Osteoarthritis Knees Both | Osteoarthritis Knee Left | Osteoarthritis Knee RightUnited States
-
University Hospital, Clermont-FerrandSanofiCompletedKnee Osteoarthritis (Knee OA)France
-
Joseph E. BroylesCompletedDegenerative Lesion of Articular Cartilage of Knee | Degeneration; Articular Cartilage, Knee | Unilateral Primary Osteoarthritis of Knee | Osteoarthritis Knee
-
Jiangsu XinChen-Techfields Pharma Co., LTD.Completed
-
The Hong Kong Polytechnic UniversityCompleted
-
Federal University of São PauloCompletedKNEE OSTEOARTHRITISBrazil
-
Novartis PharmaceuticalsRecruitingSymptomatic Knee OsteoarthritisUnited States, Spain, Hungary, Argentina, Germany, Slovakia, Czechia, Belgium, Romania
-
University of BathUniversity of Oxford; 3D Metal Printing Ltd; Versus ArthritisRecruitingMedial Knee OsteoarthritisUnited Kingdom
-
Max Biocare Pty. Ltd.Completed
Clinical Trials on compare the effects of steroid plus hyaluronic acid and destrose plus hyaluronic acid on knee osteroarthritis
-
Taipei Medical UniversityShin Kong Wu Ho-Su Memorial HospitalEnrolling by invitationKnee Osteoarthritis | Injection | Effect of DrugTaiwan
-
Pius-Hospital OldenburgUnknown
-
Kaohsiung Veterans General Hospital.Completed
-
EmoledRecruitingPressure Ulcer | Pressure Ulcers Stage II | Pressure Ulcers Stage III | Pressure SoreItaly
-
Maimónides Biomedical Research Institute of CórdobaCompletedOsteo Arthritis Knee
-
Taiwan Bio Therapeutics Co., Ltd.A2 Healthcare Taiwan CorporationActive, not recruiting
-
SciVision Biotech Inc.Completed
-
Medical University of WarsawRecruiting
-
SOFAR S.p.A.Completed
-
Brazilan Center for Studies in DermatologyCompleted