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Effects of Hyaluronic Acid vs. Hyaluronic Acid on Knee Osteoarthritis

NCT ID: NCT02625727

Last Updated: 2015-12-09

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

PHASE4

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-07-31

Brief Summary

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Using double blind, randomized controlled design to study the immediate, short-term and intermediate-term therapeutic effects of ultrasound guided hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis.

Detailed Description

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A total of 76 patients will be collected. The participants will be randomized into two groups, including hyaluronic acid injection group and hyaluronic acid combined corticosteroid injection group.

Physical activity will be evaluated. The hyaluronic acid group will receive three times of hyaluronic acid injection per week in three weeks; the hyaluronic acid combined corticosteroid group will receive hyaluronic acid combined corticosteroid injection in the first week, followed by hyaluronic acid injection at the second and third week.

Re-evaluation will be arranged at after one week of injection, after two weeks of injection, one week after injection, one month after injection, three months after injection, and six month after injection.

Conditions

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Physical Activity

Keywords

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knee osteoarthritis hyaluronic acid corticosteroid intra-articular injection therapeutic effect

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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hyaluronic acid group

hyaluronic acid injection

Group Type EXPERIMENTAL

hyaluronic acid

Intervention Type OTHER

compare the therapeutic effects of hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis

hyaluronic acid and corticosteroid group

hyaluronic acid combined corticosteroid injection

Group Type ACTIVE_COMPARATOR

hyaluronic acid combined corticosteroid

Intervention Type OTHER

compare the therapeutic effects of hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis

Interventions

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hyaluronic acid

compare the therapeutic effects of hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis

Intervention Type OTHER

hyaluronic acid combined corticosteroid

compare the therapeutic effects of hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Osteoarthritis of knee with Kellgren/Lawrence grade II or III

Exclusion Criteria

* Who have implant in knee
* History of neurological deficit, such as stroke
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shin Kong Wu Ho-Su Memorial Hospital

OTHER

Sponsor Role collaborator

Taipei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ru-Lan Hsieh

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ru-Lan Hsieh, MD

Role: PRINCIPAL_INVESTIGATOR

associate professor

Locations

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Shin Kong Wu Ho-Su Memorial Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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MOST104-2314-B-341-001

Identifier Type: -

Identifier Source: org_study_id