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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03047096
• Other study ID #: ZhongdaH2017
• Status: Recruiting
• Phase: Phase 1
• First received: February 5, 2017
• Last updated: February 8, 2017
• Start date: February 1, 2017
• Est. completion date: August 30, 2017

Study information

• Verified date: February 2017
• Source: Zhongda Hospital
• Contact: Shan-zheng Wang, MD
• Phone: +86 15062274599
• Email: wang_seu_edu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 30, 2017
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intra-articular Injection
• Osteoarthritis
• Osteoarthritis, Knee
• Pain Syndrome

Intervention

Drug:
• hyaluronic acid
intra-Articular injection
• hyaluronic acid and corticosteroids
intra-Articular injection

Locations

Country	Name	City	State
China	Zhongda Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS	Visual analog scale	6 months
Secondary	WOMAC	Western Ontario and McMaster University Osteoarthritis Index	6 months
Secondary	Knee flexion motion	Knee flexion motion	6 months