The Comparison of Two Crosslinked Hyaluronate for the Treatment of Osteoarthritis Pain

Osteoarthritis, Knee Clinical Trial

Official title:

The Comparison of Safety and Effectiveness Between HYAJOINT Plus and Bioventus Durolane for the Treatment of Knee Osteoarthritis Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04000204
• Other study ID #: RDCT-CKHP
• Status: Completed
• Phase: N/A
• Start date: June 20, 2017
• Est. completion date: July 12, 2019

Study information

• Verified date: May 2020
• Source: SciVision Biotech Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: July 12, 2019
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• HYAJOINT Plus
60 mg / 3 ml cross-linked hyaluronan, SciVision Biotech Inc.
• Durolane
60 mg / 3 ml cross-linked hyaluronan, Bioventus LLC.

Locations

Country	Name	City	State
Taiwan	National Cheng-Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
SciVision Biotech Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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'	Baseline, 1, 3, 9 and 12 months post-injection
Secondary	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.	1, 3, 6, 9 and 12 months post-injection
Secondary	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.	Baseline, 1, 3, 6, 9 and 12 months post-injection
Secondary	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'.	Baseline, 1, 3, 6, 9 and 12 months post-injection
Secondary	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'.	1, 3, 6, 9 and 12 months post-injection
Secondary	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.	Baseline, 1, 3, 6, 9 and 12 months post-injection
Secondary	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.	Baseline, 1, 3, 6, 9 and 12 months post-injection
Secondary	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.	Baseline, 1, 3, 6, 9 and 12 months post-injection