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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: HYAJOINT Plus; Device: Durolane

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 704
    • National Cheng-Kung University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HYAJOINT Plus	Device: HYAJOINT Plus; 60 mg / 3 ml cross-linked hyaluronan, SciVision Biotech Inc.
Active Comparator: Durolane	Device: Durolane; 60 mg / 3 ml cross-linked hyaluronan, Bioventus LLC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: SciVision Biotech Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2017
• Primary Completion (Actual): June 15, 2018
• Study Completion (Actual): July 12, 2019

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: June 26, 2019
• First Posted (Actual): June 27, 2019

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 26, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Osteoarthritis; hyaluronic acid; synovial fluid supplement
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: RDCT-CKHP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No