Back to resultsIntra-articular Injections of Platelet-rich Plasma, Hyaluronic Acid, or Corticosteroids for Knee Osteoarthritis
Primary Purpose
Osteoarthritis, Knee
Status
Unknown status
Phase
Phase 3
Locations
Iraq
Study Type
Interventional
Intervention
Platelet-rich plasma
Hyaluronic acid
Methylprednisolone acetate injectable suspension (DEPO-MEDROL®)
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
Inclusion Criteria:
- Patient aged 35-65 years old
- Patient with knee pain that had been continuing for at least 12 months with no relief using anti-inflammatory medications and that deteriorated with weight-bearing
- Knee osteoarthritis that classified as mild-moderate or moderate-severe (Kellgren-Lawrence Grade 2, 3, or 4)
Exclusion Criteria:
- Age > 65 years
- The recent history of knee trauma
- Autoimmune rheumatic diseases
- Accompanying severe hip OA
- Thrombocytopenia or other blood diseases
- Immunosuppressive or anticoagulant treatment
- The invasive procedure applied to the knee
- Intra-articular steroid injection to the knee within the previous 12 months
- Previous joint infection
- Uncontrolled systemic diseases such as diabetes or hypertension, and cancer
- Excessive varus/valgus knee deformity
Sites / Locations
- University of Wasit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Platelet-rich plasma arm
Hyaluronic acid arm
Methylprednisolone acetate arm
Arm Description
Outcomes
Primary Outcome Measures
Timed Up and Go test (TUG)
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees
Visual Analogue Scale (VAS)
The VAS uses a straight 10 centimeter line with one end being 'no pain' and on the other end the 'worst imaginable pain'. The patient chooses a spot on the line then places a perpendicular line to indicate their pain level
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04980105
Brief Title
Intra-articular Injections of Platelet-rich Plasma, Hyaluronic Acid, or Corticosteroids for Knee Osteoarthritis
Official Title
Intra-articular Injections of Platelet-rich Plasma, Hyaluronic Acid, or Corticosteroids for Knee Osteoarthritis, Which is Better? A Prospective Study of a Single-blind Randomized Control Trial RCT From the Iraqi Population
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 2, 2020 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Wasit
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
To assess if there are any differences among platelet-rich plasma, hyaluronic acid, and corticosteroid knee intra-articular injection regarding function and pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A total of 150 participants fulfilling the inclusion criteria, patients were randomly assigned into three groups by a computer-based protocol. The patients were separated into three groups according to the type of treatment administered.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Platelet-rich plasma arm
Arm Type
Experimental
Arm Title
Hyaluronic acid arm
Arm Type
Active Comparator
Arm Title
Methylprednisolone acetate arm
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Platelet-rich plasma
Intervention Description
Two intra-articular injections of autologous platelets-rich plasma (PRP) in two weeks intervals between the first and the second injection.
Intervention Type
Drug
Intervention Name(s)
Hyaluronic acid
Intervention Description
Two intraarticular injections of hyaluronic acid (60 mg) in two weeks intervals between the first and the second injection
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone acetate injectable suspension (DEPO-MEDROL®)
Intervention Description
Single methylprednisolone acetate intraarticular injection (DEPO-MEDROL® pfizer 80 mg) mixed with 3cc of (xylocaine 2% concentration)
Primary Outcome Measure Information:
Title
Timed Up and Go test (TUG)
Description
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees
Time Frame
18th months
Title
Visual Analogue Scale (VAS)
Description
The VAS uses a straight 10 centimeter line with one end being 'no pain' and on the other end the 'worst imaginable pain'. The patient chooses a spot on the line then places a perpendicular line to indicate their pain level
Time Frame
18th months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient aged 35-65 years old
Patient with knee pain that had been continuing for at least 12 months with no relief using anti-inflammatory medications and that deteriorated with weight-bearing
Knee osteoarthritis that classified as mild-moderate or moderate-severe (Kellgren-Lawrence Grade 2, 3, or 4)
Exclusion Criteria:
Age > 65 years
The recent history of knee trauma
Autoimmune rheumatic diseases
Accompanying severe hip OA
Thrombocytopenia or other blood diseases
Immunosuppressive or anticoagulant treatment
The invasive procedure applied to the knee
Intra-articular steroid injection to the knee within the previous 12 months
Previous joint infection
Uncontrolled systemic diseases such as diabetes or hypertension, and cancer
Excessive varus/valgus knee deformity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Usama A Al-Sari, PhD
Organizational Affiliation
UOW
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wasit
City
Wasit
Country
Iraq
12. IPD Sharing Statement
Learn more about this trial
Intra-articular Injections of Platelet-rich Plasma, Hyaluronic Acid, or Corticosteroids for Knee Osteoarthritis
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