Intra-Articular, Single-shot Injection of Hyaluronic Acid and Corticosteroids in Knee Osteoarthritis

NCT ID: NCT03047096

Last Updated: 2017-02-10

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

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2017-08-30

Brief Summary

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The aim of present study is to to investigate whether the combined injection of HA and CS was superior than HA alone in the treatment of knee OA.

Detailed Description

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Intra-articular injection of hyaluronic acid (HA) or corticosteroids (CS) has been widely used with debate on its efficacy in osteoarthritis (OA). The aim of present study is to to investigate whether the combined injection of HA and CS is superior than HA alone in the treatment of knee OA.

Conditions

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Osteoarthritis Pain Syndrome Intra-articular Injection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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HA & CS group

hyaluronic acid and corticosteroids

Group Type EXPERIMENTAL

hyaluronic acid and corticosteroids

Intervention Type DRUG

intra-Articular injection

HA group

hyaluronic acid

Group Type EXPERIMENTAL

hyaluronic acid

Intervention Type DRUG

intra-Articular injection

Interventions

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hyaluronic acid

intra-Articular injection

Intervention Type DRUG

hyaluronic acid and corticosteroids

intra-Articular injection

Intervention Type DRUG

Other Intervention Names

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HA HA and CS

Eligibility Criteria

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Inclusion Criteria

According to radiographic findings, patients who are suffering from knee OA for over 3 months have to be stage II-IV according to the Kellgren-Lawrence (KL) grade by a senior radiologist. The diagnosis of symptomatic knee OA is based on American Rheumatism Association classification criteria for knee osteoarthritis.
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhongda Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Shan-zheng Wang

Assitant secretory of Orthopaedics department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shan-zheng Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Zhongda Hospital

Locations

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Zhongda Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shan-zheng Wang, MD

Role: CONTACT

+86 15062274599

Facility Contacts

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Shan-zheng Wang, MD

Role: primary

+86 15062274599

Other Identifiers

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ZhongdaH2017

Identifier Type: -

Identifier Source: org_study_id

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