Back to resultsIntra-Articular, Single-shot Injection of Hyaluronic Acid and Corticosteroids in Knee Osteoarthritis
Primary Purpose
Osteoarthritis, Pain Syndrome, Intra-articular Injection
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
hyaluronic acid
hyaluronic acid and corticosteroids
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
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.
Sites / Locations
- Zhongda HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
HA & CS group
HA group
Arm Description
hyaluronic acid and corticosteroids
hyaluronic acid
Outcomes
Primary Outcome Measures
VAS
Visual analog scale
Secondary Outcome Measures
WOMAC
Western Ontario and McMaster University Osteoarthritis Index
Knee flexion motion
Knee flexion motion
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03047096
Brief Title
Intra-Articular, Single-shot Injection of Hyaluronic Acid and Corticosteroids in Knee Osteoarthritis
Official Title
Intra-Articular, Single-shot Injection of Hyaluronic Acid and Corticosteroids in Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
August 30, 2017 (Anticipated)
Study Completion Date
August 30, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongda Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Pain Syndrome, Intra-articular Injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HA & CS group
Arm Type
Experimental
Arm Description
hyaluronic acid and corticosteroids
Arm Title
HA group
Arm Type
Experimental
Arm Description
hyaluronic acid
Intervention Type
Drug
Intervention Name(s)
hyaluronic acid
Other Intervention Name(s)
HA
Intervention Description
intra-Articular injection
Intervention Type
Drug
Intervention Name(s)
hyaluronic acid and corticosteroids
Other Intervention Name(s)
HA and CS
Intervention Description
intra-Articular injection
Primary Outcome Measure Information:
Title
VAS
Description
Visual analog scale
Time Frame
6 months
Secondary Outcome Measure Information:
Title
WOMAC
Description
Western Ontario and McMaster University Osteoarthritis Index
Time Frame
6 months
Title
Knee flexion motion
Description
Knee flexion motion
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shan-zheng Wang, MD
Phone
+86 15062274599
Email
wang_seu_edu@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shan-zheng Wang, MD
Organizational Affiliation
Zhongda Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongda Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shan-zheng Wang, MD
Phone
+86 15062274599
Email
wang_seu_edu@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intra-Articular, Single-shot Injection of Hyaluronic Acid and Corticosteroids in Knee Osteoarthritis
We'll reach out to this number within 24 hrs