Back to resultsComparing Effect of Autologous Platelet-Rich Plasma Versus Hyaluronic Acid Treatment on Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Platelet Rich Plasma
Hyaluronic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- patients older than 50 years
- a diagnosis of primary knee osteoarthritis
- Kellgren-Lawrence (K-L) grading scale smaller than 3
- both male and female.
Exclusion Criteria:
- patients younger than 50 years of age
- K-L grade 3 or more
- history or active presence of clinically significant inflammatory articular or rheumatic disease other than OA
- generalized OA
- the detection of rapidly progressive OA before the start of the trial
- underwent any previous lower extremity surgery
- excessive mechanical axis deviation (varus > 5°, valgus > 5°)
- body mass index larger than 30
- history or presence of malignant disorders
- systemic disorders such as diabetes mellitus, severe cardiovascular diseases, hematologic diseases, immune-deficiencies, and infections
- systematic or intra-articular corticosteroid therapy in the previous 3 months
- prior treatment with HA in the past 6 months
- anticoagulants or antiaggregants therapy in the preceding 30 days
- non-steroidal anti-inflammatory medications in the preceding 7 days
- platelet count less than 150,000/ml of blood
- hemoglobin values less than 12g/dL of blood.
Sites / Locations
- Kaohsiung Medical University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Platelet Rich Plasma group
Hyaluronic Acid group
Arm Description
single injection platelet rich plasma
single injection of hyaluronic acid
Outcomes
Primary Outcome Measures
The change of Western Ontario and McMaster Universities Index (WOMAC) score from baseline
The minimum value of Western Ontario and McMaster Universities Index (WOMAC) score is zero and the maximum is 96, whether higher scores mean a worse outcome.
Secondary Outcome Measures
The change of Knee Cartilage Grading System from baseline
The Cartilage Grading System classifies the cartilage from grades 0 to 6 according to parameters of sharpness, clarity and thickness change of the cartilage band. Grade 0 refers to normal and healthy cartilage, while grade 6 refers to severely eroded cartilage, whether higher scores mean a worse outcome.
The change of Knee Cartilage strain ratio from baseline
The strain represents the elasticity. We used the overlying soft tissue as reference. Larger strain ratio means the cartilage is softer, while smaller strain ratio means the cartilage is harder.
The change of MRI Osteoarthritis Knee Score (MOAKS) from baseline
Fourteen subregions are defined for scoring of articular cartilage and bone marrow lesions in cluding patella, femur and tibia region. Grade 0 refers to normal and healthy cartilage without loss, while grade 3 refers >75% cartilage full thickness loss, whether higher scores mean a worse outcome.
Full Information
NCT ID
NCT04972383
First Posted
July 6, 2021
Last Updated
October 8, 2023
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04972383
Brief Title
Comparing Effect of Autologous Platelet-Rich Plasma Versus Hyaluronic Acid Treatment on Knee Osteoarthritis
Official Title
A Prospective,Double-Blind Randomized Controlled Trial Comparing Effect of Autologous Platelet-Rich Plasma Versus Hyaluronic Acid Treatment on Progression of Structural Changes in Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 7, 2017 (Actual)
Primary Completion Date
October 16, 2019 (Actual)
Study Completion Date
October 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial 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
To compare the efficacy and structural change of intraarticular single platelet-rich plasma(PRP) versus novel crosslinked Hyaluronic Acid(HA)(HyajointPlus) for the treatment of early stage knee osteoarthritis(OA). This was a prospective, double-blind, RCT with an allocation ratio of 1:1.
Detailed Description
In the PRP group, an Aeon Acti-PRP set was used and an approximately 4-mL PRP volume was yielded and was used in a single-dose treatment. In the HA group, HYAJOINT Plus containing 60 mg of purified sodium hyaluronate was used in a single-dose treatment. All PRP and HA injection syringes were covered with opaque envelop, and the intra-articular injection procedure was performed by the same physician without ultrasound or other imaging guidance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Platelet Rich Plasma group
Arm Type
Experimental
Arm Description
single injection platelet rich plasma
Arm Title
Hyaluronic Acid group
Arm Type
Experimental
Arm Description
single injection of hyaluronic acid
Intervention Type
Combination Product
Intervention Name(s)
Platelet Rich Plasma
Intervention Description
In the Platelet Rich Plasma group, 4mL Platelet Rich Plasma was given.
Intervention Type
Combination Product
Intervention Name(s)
Hyaluronic Acid
Intervention Description
In the Hyaluronic group, 3mLHYAJOINT Plus was given.
Primary Outcome Measure Information:
Title
The change of Western Ontario and McMaster Universities Index (WOMAC) score from baseline
Description
The minimum value of Western Ontario and McMaster Universities Index (WOMAC) score is zero and the maximum is 96, whether higher scores mean a worse outcome.
Time Frame
Baseline and 1-month, 3-month, 6-month after injection
Secondary Outcome Measure Information:
Title
The change of Knee Cartilage Grading System from baseline
Description
The Cartilage Grading System classifies the cartilage from grades 0 to 6 according to parameters of sharpness, clarity and thickness change of the cartilage band. Grade 0 refers to normal and healthy cartilage, while grade 6 refers to severely eroded cartilage, whether higher scores mean a worse outcome.
Time Frame
Baseline and 1-month, 3-month, 6-month after injection
Title
The change of Knee Cartilage strain ratio from baseline
Description
The strain represents the elasticity. We used the overlying soft tissue as reference. Larger strain ratio means the cartilage is softer, while smaller strain ratio means the cartilage is harder.
Time Frame
Baseline and 1-month, 3-month, 6-month after injection
Title
The change of MRI Osteoarthritis Knee Score (MOAKS) from baseline
Description
Fourteen subregions are defined for scoring of articular cartilage and bone marrow lesions in cluding patella, femur and tibia region. Grade 0 refers to normal and healthy cartilage without loss, while grade 3 refers >75% cartilage full thickness loss, whether higher scores mean a worse outcome.
Time Frame
Baseline and 6-month after injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients older than 50 years
a diagnosis of primary knee osteoarthritis
Kellgren-Lawrence (K-L) grading scale smaller than 3
both male and female.
Exclusion Criteria:
patients younger than 50 years of age
K-L grade 3 or more
history or active presence of clinically significant inflammatory articular or rheumatic disease other than OA
generalized OA
the detection of rapidly progressive OA before the start of the trial
underwent any previous lower extremity surgery
excessive mechanical axis deviation (varus > 5°, valgus > 5°)
body mass index larger than 30
history or presence of malignant disorders
systemic disorders such as diabetes mellitus, severe cardiovascular diseases, hematologic diseases, immune-deficiencies, and infections
systematic or intra-articular corticosteroid therapy in the previous 3 months
prior treatment with HA in the past 6 months
anticoagulants or antiaggregants therapy in the preceding 30 days
non-steroidal anti-inflammatory medications in the preceding 7 days
platelet count less than 150,000/ml of blood
hemoglobin values less than 12g/dL of blood.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsuan-Ti Huang, M.D
Organizational Affiliation
Kaohsiung Medical University, Orthopedics Department
Official's Role
Study Chair
Facility Information:
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung City
ZIP/Postal Code
807
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication
IPD Sharing Time Frame
starting 12 months after publication
IPD Sharing Access Criteria
Studies involving platelet rich plasma, hyaluronic acid can contact us for additional information.
Learn more about this trial
Comparing Effect of Autologous Platelet-Rich Plasma Versus Hyaluronic Acid Treatment on Knee Osteoarthritis
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