- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02625727
Effects of Hyaluronic Acid vs. Hyaluronic Acid on Knee Osteoarthritis
Comparison of Therapeutic Effects of Hyaluronic Acid vs. Hyaluronic Acid Combined Corticosteroid on Knee Osteoarthritis: A Double Blind, Randomized-controlled Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A total of 76 patients will be collected. The participants will be randomized into two groups, including hyaluronic acid injection group and hyaluronic acid combined corticosteroid injection group.
Physical activity will be evaluated. The hyaluronic acid group will receive three times of hyaluronic acid injection per week in three weeks; the hyaluronic acid combined corticosteroid group will receive hyaluronic acid combined corticosteroid injection in the first week, followed by hyaluronic acid injection at the second and third week.
Re-evaluation will be arranged at after one week of injection, after two weeks of injection, one week after injection, one month after injection, three months after injection, and six month after injection.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Taipei, Taiwan, 111-01
- Shin Kong Wu Ho-Su Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Osteoarthritis of knee with Kellgren/Lawrence grade II or III
Exclusion Criteria:
- Who have implant in knee
- History of neurological deficit, such as stroke
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: hyaluronic acid group
hyaluronic acid injection
|
compare the therapeutic effects of hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis
|
Active Comparator: hyaluronic acid and corticosteroid group
hyaluronic acid combined corticosteroid injection
|
compare the therapeutic effects of hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
physical activity
Time Frame: changes from baseline at after one week of injection, after two weeks of injection, one week after injection, one month after injection, three months after injection, and six month after injection
|
changes from baseline at after one week of injection, after two weeks of injection, one week after injection, one month after injection, three months after injection, and six month after injection
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
functional performance (Western Ontario and McMaster Universities Osteoarthritis index)
Time Frame: changes from baseline at after one week of injection, after two weeks of injection, one week after injection, one month after injection, three months after injection, and six month after injection
|
changes from baseline at after one week of injection, after two weeks of injection, one week after injection, one month after injection, three months after injection, and six month after injection
|
functional performance (Knee injury and Osteoarthritis Outcome Score)
Time Frame: changes from baseline at after one week of injection, after two weeks of injection, one week after injection, one month after injection, three months after injection, and six month after injection
|
changes from baseline at after one week of injection, after two weeks of injection, one week after injection, one month after injection, three months after injection, and six month after injection
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ru-Lan Hsieh, MD, Associate Professor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOST104-2314-B-341-001
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.
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