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

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Device: Durolane; Device: HYAJOINT Plus

• Registration Number: NCT04000204
• Lead Sponsor: SciVision Biotech Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-20
• Primary Completion: 2018-06-15
• Study First Submitted: 2019-06-18
• Study First Submitted QC: 2019-06-26
• Study First Posted: 2019-06-27
• Study Completion: 2019-07-12
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-26
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Durolane	Durolane	-
HYAJOINT Plus	HYAJOINT Plus	-

Primary Outcome Measures

Name	Time	Method
The change from baseline VAS pain score at 6 months post-injection.	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

Name	Time	Method
Adverse events reported from the baseline and during the study period	1, 3, 6, 9 and 12 months post-injection	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.
Knee joint inflammatory state change by ultrasonic inspection	Baseline, 1, 3, 6, 9 and 12 months post-injection	The change from baseline of the subject knee inflammatory state at 1, 3, 6, 9 and 12 months post-injection through ultrasonic inspection.
Visual analog scale (VAS) score for pain change	Baseline, 1, 3, 9 and 12 months post-injection	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'
Visual analog scale (VAS) score for satisfaction change	1, 3, 6, 9 and 12 months post-injection	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	Baseline, 1, 3, 6, 9 and 12 months post-injection	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	Baseline, 1, 3, 6, 9 and 12 months post-injection	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.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert scale score change	Baseline, 1, 3, 6, 9 and 12 months post-injection	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	Baseline, 1, 3, 6, 9 and 12 months post-injection	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'.

Trial Locations

Locations (1)

National Cheng-Kung University Hospital; 🇨🇳 Tainan, Taiwan