Osteoarthritis, KneeNCT04000204
The Comparison of Two Crosslinked Hyaluronate for the Treatment of Osteoarthritis Pain
A study testing HYAJOINT Plus and Durolane in people with Osteoarthritis, Knee, run by SciVision Biotech Inc. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- HYAJOINT Plus and Durolane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Jun 2017to 12 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison of Safety and Effectiveness Between HYAJOINT Plus and Bioventus Durolane for the Treatment of Knee Osteoarthritis Pain
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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- HYAJOINT Plus, Durolane
- Keywords
- Osteoarthritis, synovial fluid supplement, hyaluronic acid
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HYAJOINT PlusDevice
60 mg / 3 ml cross-linked hyaluronan, SciVision Biotech Inc.
DurolaneDevice
60 mg / 3 ml cross-linked hyaluronan, Bioventus LLC.
| Study group | Role | What they receive |
|---|---|---|
| HYAJOINT Plus | Experimental | Not described Receives: Device: HYAJOINT Plus |
| Durolane | Active comparator | Not described Receives: Device: Durolane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'
Measured: 6 months post-injection
Secondary outcomes (8)
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'
Measured: Baseline, 1, 3, 9 and 12 months post-injection
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.
Measured: 1, 3, 6, 9 and 12 months post-injection
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.
Measured: Baseline, 1, 3, 6, 9 and 12 months post-injection
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'.
Measured: Baseline, 1, 3, 6, 9 and 12 months post-injection
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'.
Measured: 1, 3, 6, 9 and 12 months post-injection
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.
Measured: Baseline, 1, 3, 6, 9 and 12 months post-injection
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.
Measured: Baseline, 1, 3, 6, 9 and 12 months post-injection
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.
Measured: Baseline, 1, 3, 6, 9 and 12 months post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start20 Jun 2017
- Primary completion15 Jun 2018
- Study completion12 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- SciVision Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000204
- Sponsor's protocol ID
- RDCT-CKHP
- Status last verified
- May 2020
- First submitted
- 18 Jun 2019
- Last updated
- 27 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Safety and Effectiveness Between HYAJOINT Plus and Bioventus Durolane for the Treatment of Knee Osteoarthritis Pain
- ClinicalTrials.gov ID
- NCT04000204
- Acronym / sponsor ID
- RDCT-CKHP
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, synovial fluid supplement, hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- SciVision Biotech Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 12 Jul 2019 (actual)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HYAJOINT Plus | Experimental | Device: HYAJOINT Plus |
| Durolane | Active comparator | Device: Durolane |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HYAJOINT Plus60 mg / 3 ml cross-linked hyaluronan, SciVision Biotech Inc. | Device | HYAJOINT Plus |
| Durolane60 mg / 3 ml cross-linked hyaluronan, Bioventus LLC. | Device | Durolane |
Primary outcome
The change from baseline VAS pain score at 6 months post-injection.
Time frame: 6 months post-injection
The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'
8 secondary outcomes
Visual analog scale (VAS) score for pain change
Time frame: Baseline, 1, 3, 9 and 12 months post-injection
Adverse events reported from the baseline and during the study period
Time frame: 1, 3, 6, 9 and 12 months post-injection
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert scale score change
Time frame: Baseline, 1, 3, 6, 9 and 12 months post-injection
Visual analog scale (VAS) score for stiffness change
Time frame: Baseline, 1, 3, 6, 9 and 12 months post-injection
Visual analog scale (VAS) score for satisfaction change
Time frame: 1, 3, 6, 9 and 12 months post-injection
Timed Up-and-Go test (TUG) change
Time frame: Baseline, 1, 3, 6, 9 and 12 months post-injection
Single-leg stance test (SLS) change
Time frame: Baseline, 1, 3, 6, 9 and 12 months post-injection
Knee joint inflammatory state change by ultrasonic inspection
Time frame: Baseline, 1, 3, 6, 9 and 12 months post-injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HYAJOINT Plus and Durolane in people with Osteoarthritis, Knee, run by SciVision Biotech Inc. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline VAS pain score at 6 months post-injection. (time frame: 6 months post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020.