Clinical trial NCT04000204: The Comparison of Two Crosslinked Hyaluronate for the Treatment of Osteoarthritis Pain
Official title: The Comparison of Safety and Effectiveness Between HYAJOINT Plus and Bioventus Durolane for the Treatment of Knee Osteoarthritis Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis
synovial fluid supplement
hyaluronic acid
Lead sponsor: SciVision Biotech Inc.
Sponsor class: INDUSTRY
First posted: 2019-06-27
Enrollment: 142
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. age from 35 to 85 years;
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:

1. previous orthopedic surgery in the lower extremity;
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.

Primary outcomes:
measure: The change from baseline VAS pain score at 6 months post-injection.
timeFrame: 6 months post-injection
Secondary outcomes:
measure: Visual analog scale (VAS) score for pain change
timeFrame: Baseline, 1, 3, 9 and 12 months post-injection
measure: Adverse events reported from the baseline and during the study period
timeFrame: 1, 3, 6, 9 and 12 months post-injection
measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert scale score change
timeFrame: Baseline, 1, 3, 6, 9 and 12 months post-injection
measure: Visual analog scale (VAS) score for stiffness change
timeFrame: Baseline, 1, 3, 6, 9 and 12 months post-injection
measure: Visual analog scale (VAS) score for satisfaction change
timeFrame: 1, 3, 6, 9 and 12 months post-injection
measure: Timed Up-and-Go test (TUG) change
timeFrame: Baseline, 1, 3, 6, 9 and 12 months post-injection
measure: Single-leg stance test (SLS) change
timeFrame: Baseline, 1, 3, 6, 9 and 12 months post-injection
measure: Knee joint inflammatory state change by ultrasonic inspection
timeFrame: Baseline, 1, 3, 6, 9 and 12 months post-injection
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
Study officials:
References: