Observational Study of Synovian® Inj. in Patients With Osteoarthritis in the Knee

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

Total Enrollment

1949 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-09

Study Completion Date

2019-08-08

Brief Summary

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This is an observational study to evaluate the injection site reactions of Synovian® Inj. in patients with osteoarthritis in the knee

Detailed Description

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Conditions

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Osteoarthritis in the Knee

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Synovian®

Synovian® Inj.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult male or female patient of over 19 years of age
* A patient diagnosed with knee osteoarthritis
* A patient who has been informed of the purpose, method of the study and signed the written informed consent form.

Exclusion Criteria

* A patient who shows hypersensitive reaction to the Synovian® Inj. or to the ingredients of Synovian® Inj.
* A patient with infection at the joint
* A patient with skin infection or skin disease at the injection area
* A patient diagnosed with osteoarthritis with the Kellgren \& Lawrence Grade IV in X-ray within 12 months before enrollment of this study.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hanyang University GURI Hospital

Guri-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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Jang KM, Park YG, Choi WK, Chung YY, Kim KK, Lee JW, Lee SJ, Eom Y, Yang JH. Safety of a single intra-articular injection of LBSA0103 hyaluronic acid in patients with osteoarthritis of the knee: a multicenter, single-arm, prospective, cohort study. Curr Med Res Opin. 2021 Sep;37(9):1573-1580. doi: 10.1080/03007995.2021.1950132. Epub 2021 Jul 15.

Reference Type DERIVED

PMID: 34192989 (View on PubMed)

Other Identifiers

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LG-HAOS006

Identifier Type: -

Identifier Source: org_study_id