Comparison of Hyaluronic Acid and Platelet-rich Plasma Injections

Study Overview
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Brief Summary
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This study aims to compare the effects of hyaluronic acid injection and platelet rich plasma injection in terms of pain, physical function and femoral cartilage thickness in short term treatment in patients with knee osteoarthritis.

Detailed Description
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Platelet-rich plasma and hyaluronic acid injections are both popular treatments and commonly used for treatment of knee osteoarthritis. Even though there are many studies investigating the effectiveness of these treatments, the results are mostly qualitative. Also there are a few studies comparing these two treatment modalities. In this study the investigators aim to compare these modalities both for self-reported data (pain, physical function) and objective measurement data (femoral cartilage thickness via ultrasonography). Patients with unilateral osteoarthritis/unilateral complaint will be included in the study. Unaffected side will be controls for each group.

Official Title
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Comparison of Hyaluronic Acid and Platelet-rich Plasma Injection on Pain, Physical Function and Femoral Cartilage Thickness in Patients With Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Biological: Hyaluronic acid injection
* Biological: Platelet-rich plasma injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is able to consent Subject meets Osteoarthritis Research Society International (OARSI) criteria for knee osteoarthritis Subject has radiographic Kellgren-Lawrence grade 2-3 osteoarthritis Unilateral osteoarthritis/complaint Exclusion Criteria: Past or actual knee infection History of surgery, fracture on knee Collagen tissue disease Systemic inflammatory disease (rheumatoid arthritis, spondyloarthritis etc.) Systemic diseases (diabetes, hematologic diseases, endocrinopathies, renal failure, liver failure) Knee injection in past 6 months Immunodeficiency Pregnant/breastfeeding Malignancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hyaluronic acid injection<br>Hyaluronic acid 48 mg 2.0% in 2 ml solution, once initially. | Biological: Hyaluronic acid injection<br>* Hyaluronic acid 48 mg 2.0% in 2.4 ml solution<br>* Other names: Reviscon Mono;|
| Active Comparator: Platelet-rich plasma injection<br>Platelet-rich plasma 5 ml, once initially | Biological: Platelet-rich plasma injection<br>* Platelet-rich plasma injection 5ml<br>|
| No Intervention: Unaffected side Hyaluronic acid<br>Unaffected sides of the patients will be controls for hyaluronic acid group, no intervention. | |
| No Intervention: Unaffected side Platelet-rich plasma<br>Unaffected sides of the patients will be controls for Platelet-rich plasma group, no intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of numeric rating scale (rest, movement) | Self reported pain scored between 0 (minimum)-10 (maximum). Higher scores represent a worse outcome. | 0, 1st, 6th, months | 
| Change of Western Ontario and McMaster Universities Osteoarthritis Index score(WOMAC) | Self reported questionnaire investigating 24 daily living activities. Each item is scored 0-5 (0:none 5:worst). Yielding a total between 0-100. Higher scores represent a worse outcome. | 0, 1st, 6th months | 
| Change of femoral cartilage thickness via ultrasonography. | Transverse plane femoral cartilage thickness from three landmarks (from articular cartilage pothole,from midpoint of medial border and pothole of cartilage, from midpoint of lateral border and pothole of cartilage). Measured in millimeters. The sum of three points indicate a total thickness. A higher measurement indicates a thicker cartilage representing a better outcome. | 0, 1st, 6th months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Hyaluronic acid, Platelet-rich plasma, Injection