The Comparison of Two Crosslinked Hyaluronate for the Treatment of Osteoarthritis Pain
The Comparison of Safety and Effectiveness Between HYAJOINT Plus and Bioventus Durolane for the Treatment of Knee Osteoarthritis Pain
1 other identifier
interventional
142
1 country
1
Brief Summary
The aim of this study is to compare the safety and effectiveness between two BDDE-crosslinked hyaluronate, HYAJOINT Plus and Durolane, for the Treatment of Knee Osteoarthritis Pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2017
Typical duration for not_applicable
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
June 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2018
CompletedFirst Submitted
Initial submission to the registry
June 18, 2019
CompletedFirst Posted
Study publicly available on registry
June 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2019
CompletedMay 27, 2020
May 1, 2020
12 months
June 18, 2019
May 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change from baseline VAS pain score at 6 months post-injection.
The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'
6 months post-injection
Secondary Outcomes (8)
Visual analog scale (VAS) score for pain change
Baseline, 1, 3, 9 and 12 months post-injection
Adverse events reported from the baseline and during the study period
1, 3, 6, 9 and 12 months post-injection
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert scale score change
Baseline, 1, 3, 6, 9 and 12 months post-injection
Visual analog scale (VAS) score for stiffness change
Baseline, 1, 3, 6, 9 and 12 months post-injection
Visual analog scale (VAS) score for satisfaction change
1, 3, 6, 9 and 12 months post-injection
- +3 more secondary outcomes
Study Arms (2)
HYAJOINT Plus
EXPERIMENTALDurolane
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- age from 35 to 85 years;
- radiographic Kellgren-Lawrence grade II to III;
- symptoms ≧6 months despite conservative treatments such as analgesics, NSAID and/or physical therapy;
- average knee pain score ≧30mm on 100-mm visual analog scale (VAS) in recent one week;
You may not qualify if:
- previous orthopedic surgery in the lower extremity;
- disabling osteoarthritis of hip or ankle;
- previous IAHA within 6 months;
- IA steroid or joint puncture within 3 months;
- characters of severe acute synovitis under ultrasound (US) examination, such as Grade 3 in suprapatellar synovitis (SPS), suprapatellar effusion (SPE), medial compartment synovitis (MCS) or lateral compartment synovitis (LCS);
- Any specific medical condition, such as rheumatoid arthritis, Lupus erythematous, hemiparesis, infection, neoplasm, and etc., that would interfere with assessments;
- confirmed or suspected pregnancy or lactating;
- known allergy history to any avian protein or HA product.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cheng-Kung University Hospital
Tainan, 704, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2019
First Posted
June 27, 2019
Study Start
June 20, 2017
Primary Completion
June 15, 2018
Study Completion
July 12, 2019
Last Updated
May 27, 2020
Record last verified: 2020-05