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

Phase 1

• Conditions: Osteoarthritis; Pain Syndrome; Intra-articular Injection
• Interventions: Drug: hyaluronic acid; Drug: hyaluronic acid and corticosteroids

• Registration Number: NCT03047096
• Lead Sponsor: Zhongda Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2017-02
• Study Start: 2017-02-01
• Study First Submitted: 2017-02-05
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-08
• Last Update Submitted: 2017-02-08
• Last Update Posted: 2017-02-10
• Primary Completion: 2017-08-30
• Study Completion: 2017-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HA group	hyaluronic acid	hyaluronic acid
HA & CS group	hyaluronic acid and corticosteroids	hyaluronic acid and corticosteroids

Primary Outcome Measures

Name	Time	Method
VAS	6 months	Visual analog scale

Secondary Outcome Measures

Name	Time	Method
Knee flexion motion	6 months	Knee flexion motion
WOMAC	6 months	Western Ontario and McMaster University Osteoarthritis Index

Trial Locations

Locations (1)

Zhongda Hospital; 🇨🇳 Nanjing, Jiangsu, China