Back to resultsIntra-articular Corticosteroid Injection Compared With Single-Shot Hyaluronic Acid for Treatment of Osteoarthritis Knee
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Hylan G-F 20
Corticosteroid
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee Osteoarthritis, Corticosteroid, Hyaluronic acid, Intra-articular injection
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of knee OA
- Knee pain for most days of the prior month
- Radiographic evidence consistent with knee OA
- Aged between 40 and 80 years old
Exclusion Criteria:
- Lumbar spondylosis
- Gross deformity of the knee
- Co-existent inflammatory or crystal arthritis
- Prior knee surgery
- Injury to the knee in the preceding 6 months
- Any intra-articular injection in the preceding 3 months
- Pregnant or Lactating
- Current infection in the affected knee
- Inability to provide informed consent
Sites / Locations
- Thammasat University Hospital, Thammasat University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Single shot Hylan G-F 20 (Synvisc)
Corticosteroid (Triamcinolone acetonide)
Arm Description
Intra-articular injection of the Single shot 6 mL of Hylan G-F 20 (Synvisc)
Intra-articular injection of 1 mL of 40 mg Triamcinolone acetonide plus 5 mL of 1% xylocaine with adrenaline injected at the knee by single shot
Outcomes
Primary Outcome Measures
WOMAC Score
Change from Baseline in WOMAC score at 6 months
Secondary Outcome Measures
Visual Analogue Scale(VAS)
Change from Baseline in VAS score at 6 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01874574
Brief Title
Intra-articular Corticosteroid Injection Compared With Single-Shot Hyaluronic Acid for Treatment of Osteoarthritis Knee
Official Title
Intra-articular Corticosteroid Injection Compared With Single-Shot Hyaluronic Acid for Treatment of Osteoarthritis Knee: A Prospective, Double-blind Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thammasat University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Corticosteroid and Hylan G-F 20 are both effective in improving pain and function of osteoarthritic knee patients.
Detailed Description
Corticosteroid and Hylan G-F 20 are both effective in improving pain and function of osteoarthritic knee patients up to 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee Osteoarthritis, Corticosteroid, Hyaluronic acid, Intra-articular injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single shot Hylan G-F 20 (Synvisc)
Arm Type
Experimental
Arm Description
Intra-articular injection of the Single shot 6 mL of Hylan G-F 20 (Synvisc)
Arm Title
Corticosteroid (Triamcinolone acetonide)
Arm Type
Active Comparator
Arm Description
Intra-articular injection of 1 mL of 40 mg Triamcinolone acetonide plus 5 mL of 1% xylocaine with adrenaline injected at the knee by single shot
Intervention Type
Drug
Intervention Name(s)
Hylan G-F 20
Other Intervention Name(s)
Synvisc
Intervention Description
After full aseptic preparation, Single shot intra-articular injection either 6 mL of Hylan G-F 20 or 1 mL of 40 mg triamcinolone acetonide plus 5 mL of 1% xylocaine with adrenaline were injected into the joint cavity using the infero-lateral approach via a 21-gauge needle.
Intervention Type
Drug
Intervention Name(s)
Corticosteroid
Other Intervention Name(s)
Triamcinolone acetonide
Intervention Description
After full aseptic preparation, Single shot intra-articular injection either 6 mL of Hylan G-F 20 or 1 mL of 40 mg triamcinolone acetonide plus 5 mL of 1% xylocaine with adrenaline were injected into the joint cavity using the infero-lateral approach via a 21-gauge needle.
Primary Outcome Measure Information:
Title
WOMAC Score
Description
Change from Baseline in WOMAC score at 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Visual Analogue Scale(VAS)
Description
Change from Baseline in VAS score at 6 months
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of knee OA
Knee pain for most days of the prior month
Radiographic evidence consistent with knee OA
Aged between 40 and 80 years old
Exclusion Criteria:
Lumbar spondylosis
Gross deformity of the knee
Co-existent inflammatory or crystal arthritis
Prior knee surgery
Injury to the knee in the preceding 6 months
Any intra-articular injection in the preceding 3 months
Pregnant or Lactating
Current infection in the affected knee
Inability to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nattapol Tammachote, MD, MSc
Organizational Affiliation
Department of Orthopaedics, Thammasat University
Official's Role
Study Director
Facility Information:
Facility Name
Thammasat University Hospital, Thammasat University
City
Prathumthani
ZIP/Postal Code
12121
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Intra-articular Corticosteroid Injection Compared With Single-Shot Hyaluronic Acid for Treatment of Osteoarthritis Knee
We'll reach out to this number within 24 hrs