The Comparison of Two Crosslinked Hyaluronate for the Treatment of Osteoarthritis Pain
NCT ID: NCT04000204
Last Updated: 2020-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
142 participants
INTERVENTIONAL
2017-06-20
2019-07-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HYAJOINT Plus
HYAJOINT Plus
60 mg / 3 ml cross-linked hyaluronan, SciVision Biotech Inc.
Durolane
Durolane
60 mg / 3 ml cross-linked hyaluronan, Bioventus LLC.
Interventions
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HYAJOINT Plus
60 mg / 3 ml cross-linked hyaluronan, SciVision Biotech Inc.
Durolane
60 mg / 3 ml cross-linked hyaluronan, Bioventus LLC.
Eligibility Criteria
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Inclusion Criteria
2. radiographic Kellgren-Lawrence grade II to III;
3. symptoms ≧6 months despite conservative treatments such as analgesics, NSAID and/or physical therapy;
4. average knee pain score ≧30mm on 100-mm visual analog scale (VAS) in recent one week;
5. radiographic evidence of bilateral knee OA not reason for exclusion if VAS pain in contralateral knee \<30mm.
Exclusion Criteria
2. disabling osteoarthritis of hip or ankle;
3. previous IAHA within 6 months;
4. IA steroid or joint puncture within 3 months;
5. 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);
6. Any specific medical condition, such as rheumatoid arthritis, Lupus erythematous, hemiparesis, infection, neoplasm, and etc., that would interfere with assessments;
7. confirmed or suspected pregnancy or lactating;
8. known allergy history to any avian protein or HA product.
35 Years
85 Years
ALL
No
Sponsors
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SciVision Biotech Inc.
INDUSTRY
Responsible Party
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Locations
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National Cheng-Kung University Hospital
Tainan City, , Taiwan
Countries
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Other Identifiers
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RDCT-CKHP
Identifier Type: -
Identifier Source: org_study_id
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