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

Southeast University

Status and phase: Unknown; Phase 1

Conditions: Intra-articular Injection; Osteoarthritis; Pain Syndrome

Treatments: Drug: hyaluronic acid; Drug: hyaluronic acid and corticosteroids

Study type: Interventional

Funder types: Other

Identifiers

NCT03047096

ZhongdaH2017

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

Exclusion criteria are the diagnosis of rheumatoid arthritis or other inflammatory OA, presence of trauma or pain-causing diseases, treatment with oral medications in recent 3 days, physiotherapy and intra-articular injection of HA or CS in the past 6 months. Participants who are allergic to any of the medications used in this study or diagnosed with current systemic infection are also excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

HA & CS group

Experimental group

Description:

hyaluronic acid and corticosteroids

Treatment:

Drug: hyaluronic acid and corticosteroids

HA group

Experimental group

Description:

hyaluronic acid

Treatment:

Drug: hyaluronic acid