Back to resultsThe Comparison of Two Crosslinked Hyaluronate for the Treatment of Osteoarthritis Pain
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
HYAJOINT Plus
Durolane
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, synovial fluid supplement, hyaluronic acid
Eligibility Criteria
Inclusion Criteria:
- 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;
- radiographic evidence of bilateral knee OA not reason for exclusion if VAS pain in contralateral knee <30mm.
Exclusion Criteria:
- 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.
Sites / Locations
- National Cheng-Kung University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HYAJOINT Plus
Durolane
Arm Description
Outcomes
Primary Outcome Measures
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'
Secondary Outcome Measures
Visual analog scale (VAS) score for pain change
The change from baseline VAS pain score at 1, 3, 9 and 12 months post-injection. The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'
Adverse events reported from the baseline and during the study period
The safety assessment was based on reports of adverse events, defined as any unwanted events whether it was thought to be related to the study drugs or not, were recorded during each follow up and at any time the patient reported an event to the investigator during the study period.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert scale score change
The change from baseline WOMAC score at 1, 3, 6, 9 and 12 months post-injection. A 24-item questionnaire with 3 subscales measuring pain, stiffness, and physical function. Total score is 96 and lower scores indicate better outcomes.
Visual analog scale (VAS) score for stiffness change
The change from baseline VAS stiffness score at 1, 3, 6, 9 and 12 months post-injection. The VAS scale uses a 100 mm line labelled at '0' with 'no stiffness' and '100' with 'worst stiffness'.
Visual analog scale (VAS) score for satisfaction change
The change from baseline VAS satisfaction score at 1, 3, 6, 9 and 12 months post-injection. Patients rate their treatment satisfaction based on a 100 mm VAS. The VAS scale uses a 100 mm line labelled at '0' with 'least satisfaction' and '100' with 'highest satisfaction'.
Timed Up-and-Go test (TUG) change
The change from baseline TUG time at 1, 3, 6, 9 and 12 months post-injection. A simple measurement of time in seconds for a subject to rise from an armchair, walk 3 meters, turn around, walk back to the chair, and sit down.
Single-leg stance test (SLS) change
The change from baseline SLS time at 1, 3, 6, 9 and 12 months post-injection. A simple measurement of time in seconds for a subject raising one foot up without touching it to the supported lower extremity with knee OA and maintain balance for as long as possible.
Knee joint inflammatory state change by ultrasonic inspection
The change from baseline of the subject knee inflammatory state at 1, 3, 6, 9 and 12 months post-injection through ultrasonic inspection.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04000204
Brief Title
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
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
June 20, 2017 (Actual)
Primary Completion Date
June 15, 2018 (Actual)
Study Completion Date
July 12, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SciVision Biotech Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Osteoarthritis, synovial fluid supplement, hyaluronic acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HYAJOINT Plus
Arm Type
Experimental
Arm Title
Durolane
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
HYAJOINT Plus
Intervention Description
60 mg / 3 ml cross-linked hyaluronan, SciVision Biotech Inc.
Intervention Type
Device
Intervention Name(s)
Durolane
Intervention Description
60 mg / 3 ml cross-linked hyaluronan, Bioventus LLC.
Primary Outcome Measure Information:
Title
The change from baseline VAS pain score at 6 months post-injection.
Description
The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'
Time Frame
6 months post-injection
Secondary Outcome Measure Information:
Title
Visual analog scale (VAS) score for pain change
Description
The change from baseline VAS pain score at 1, 3, 9 and 12 months post-injection. The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'
Time Frame
Baseline, 1, 3, 9 and 12 months post-injection
Title
Adverse events reported from the baseline and during the study period
Description
The safety assessment was based on reports of adverse events, defined as any unwanted events whether it was thought to be related to the study drugs or not, were recorded during each follow up and at any time the patient reported an event to the investigator during the study period.
Time Frame
1, 3, 6, 9 and 12 months post-injection
Title
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert scale score change
Description
The change from baseline WOMAC score at 1, 3, 6, 9 and 12 months post-injection. A 24-item questionnaire with 3 subscales measuring pain, stiffness, and physical function. Total score is 96 and lower scores indicate better outcomes.
Time Frame
Baseline, 1, 3, 6, 9 and 12 months post-injection
Title
Visual analog scale (VAS) score for stiffness change
Description
The change from baseline VAS stiffness score at 1, 3, 6, 9 and 12 months post-injection. The VAS scale uses a 100 mm line labelled at '0' with 'no stiffness' and '100' with 'worst stiffness'.
Time Frame
Baseline, 1, 3, 6, 9 and 12 months post-injection
Title
Visual analog scale (VAS) score for satisfaction change
Description
The change from baseline VAS satisfaction score at 1, 3, 6, 9 and 12 months post-injection. Patients rate their treatment satisfaction based on a 100 mm VAS. The VAS scale uses a 100 mm line labelled at '0' with 'least satisfaction' and '100' with 'highest satisfaction'.
Time Frame
1, 3, 6, 9 and 12 months post-injection
Title
Timed Up-and-Go test (TUG) change
Description
The change from baseline TUG time at 1, 3, 6, 9 and 12 months post-injection. A simple measurement of time in seconds for a subject to rise from an armchair, walk 3 meters, turn around, walk back to the chair, and sit down.
Time Frame
Baseline, 1, 3, 6, 9 and 12 months post-injection
Title
Single-leg stance test (SLS) change
Description
The change from baseline SLS time at 1, 3, 6, 9 and 12 months post-injection. A simple measurement of time in seconds for a subject raising one foot up without touching it to the supported lower extremity with knee OA and maintain balance for as long as possible.
Time Frame
Baseline, 1, 3, 6, 9 and 12 months post-injection
Title
Knee joint inflammatory state change by ultrasonic inspection
Description
The change from baseline of the subject knee inflammatory state at 1, 3, 6, 9 and 12 months post-injection through ultrasonic inspection.
Time Frame
Baseline, 1, 3, 6, 9 and 12 months post-injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
radiographic evidence of bilateral knee OA not reason for exclusion if VAS pain in contralateral knee <30mm.
Exclusion Criteria:
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.
Facility Information:
Facility Name
National Cheng-Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
The Comparison of Two Crosslinked Hyaluronate for the Treatment of Osteoarthritis Pain
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