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
1 other identifier
interventional
76
1 country
1
Brief Summary
Using double blind, randomized controlled design to study the immediate, short-term and intermediate-term therapeutic effects of ultrasound guided hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2015
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 1, 2015
CompletedFirst Posted
Study publicly available on registry
December 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedDecember 9, 2015
December 1, 2015
11 months
December 1, 2015
December 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
physical activity
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 Outcomes (2)
functional performance (Western Ontario and McMaster Universities Osteoarthritis index)
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)
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
Study Arms (2)
hyaluronic acid group
EXPERIMENTALhyaluronic acid injection
hyaluronic acid and corticosteroid group
ACTIVE COMPARATORhyaluronic acid combined corticosteroid injection
Interventions
compare the therapeutic effects of hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis
compare the therapeutic effects of hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis
Eligibility Criteria
You may qualify if:
- Osteoarthritis of knee with Kellgren/Lawrence grade II or III
You may not qualify if:
- Who have implant in knee
- History of neurological deficit, such as stroke
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Taipei Medical Universitylead
- Shin Kong Wu Ho-Su Memorial Hospitalcollaborator
Study Sites (1)
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, 111-01, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ru-Lan Hsieh, MD
associate professor
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
December 1, 2015
First Posted
December 9, 2015
Study Start
August 1, 2015
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
December 9, 2015
Record last verified: 2015-12