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

NCT ID: NCT04000204

Last Updated: 2020-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-20

Study Completion Date

2019-07-12

Brief Summary

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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

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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HYAJOINT Plus

Group Type EXPERIMENTAL

HYAJOINT Plus

Intervention Type DEVICE

60 mg / 3 ml cross-linked hyaluronan, SciVision Biotech Inc.

Durolane

Group Type ACTIVE_COMPARATOR

Durolane

Intervention Type DEVICE

60 mg / 3 ml cross-linked hyaluronan, Bioventus LLC.

Interventions

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HYAJOINT Plus

60 mg / 3 ml cross-linked hyaluronan, SciVision Biotech Inc.

Intervention Type DEVICE

Durolane

60 mg / 3 ml cross-linked hyaluronan, Bioventus LLC.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SciVision Biotech Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Cheng-Kung University Hospital

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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RDCT-CKHP

Identifier Type: -

Identifier Source: org_study_id

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