Comparing Effect of Autologous Platelet-Rich Plasma Versus Hyaluronic Acid Treatment on Knee Osteoarthritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Combination Product: Platelet Rich Plasma
* Combination Product: Hyaluronic Acid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet Rich Plasma group<br>single injection platelet rich plasma | Combination Product: Platelet Rich Plasma<br>* In the Platelet Rich Plasma group, 4mL Platelet Rich Plasma was given.<br>|
| Experimental: Hyaluronic Acid group<br>single injection of hyaluronic acid | Combination Product: Hyaluronic Acid<br>* In the Hyaluronic group, 3mLHYAJOINT Plus was given.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 1-month, 3-month, 6-month after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 1-month, 3-month, 6-month after injection | 
| 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. | Baseline and 1-month, 3-month, 6-month after injection | 
| 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. | Baseline and 6-month after injection |