Comparison of Autologous Platelet-rich Plasma With Hyaluronic Acid for the Treatment of Osteoarthritis of the Knee Joint

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy of platelet-rich plasma versus hyaluronic acid intra-articular injections for the treatment of osteoarthritis of knee joint. The hypothesis is that PRP intra-articular injection is comparable or even better than hyaluronic acid injection.

Detailed Description
-----------------
Osteoarthritis (OA) has a significant impact on our society. The limited regenerative capacity of cartilage is part of this problem. Existing degenerative lesions lead to accelerated deterioration of the articular (joint) surface leading to end-stage arthritis. In particular, the most recent knowledge regarding tissue biology highlights a complex regulation of growth factors (GFs) for the normal tissue structure and the reaction to tissue damage. The influence of GFs on cartilage repair is now widely investigated in vitro and in vivo. Platelet Rich Plasma (PRP) is a simple, low- cost and minimally- invasive method that allows one to obtain a natural concentrate of autologous GFs from the blood, and it is increasingly applied in the clinical practice to treat knee degenerative pathology, such as chondropathy and early OA. The biological rational of PRP is that platelets contain storage pools of GFs, cytokines, chemokines and many other mediators.Although its widespread application, there are little high level studies in the literature to demonstrate the real efficacy of PRP. The investigators hypothesized that intra-articular injections of PRP to treat knee osteoarthritis could determine pain relief and recovery of knee function with overall clinical outcome comparable or even better than viscosupplementation, which is a common injective approach applied in this kind of pathology. To this purpose the investigators designed a double blind randomized controlled trial comparing PRP vs viscosupplementation.

Official Title
-----------------
Randomized, Double Blind, Comparison Clinical Trial to Test the Efficacy and Safety of Intraarticular Injection of Autologous Platelet-rich Plasma (PRP) for the Treatment of Osteoarthritis of the Knee Joint

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Biological: PRP
* Drug: Hyaluronic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with osteoarthritis of knee (by American College of Rheumatology Criteria) and Kellgren-Lawrence grade I   III More than 40 out of 100-mm VAS scale for pain at screening and baseline Participant is willing and able to give informed consent for participation in the study Exclusion Criteria: Patients with Hb values < 10 g/dl and platelet values < 100,000/ul Patients with a current or medical history of autoimmune disease Recent fever ( within 2 weeks) or serious illness Local infection at the site of the procedure Corticosteroid injection at treatment site within 1 month Systematic use of corticosteroids within 2 weeks Female participants who are pregnant, lactating or planning pregnancy during the course of the study Patients who have been administered with immunosuppressants within the past 6 weeks Patients who are enrolled in any other clinical trials within 4 weeks Patients who the principal investigator considers inappropriate for participation in the clinical trial for reasons other than those listed above

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP group<br>Patients randomized to this group of treatment will receive 1 blinded knee intra-articular injections of autologous Platelet-Rich Plasma (3ml). | Biological: PRP<br>* 3ml of PRP<br>* Other names: GPS III, Biomet Biologics, Warsaw, Ind, USA;|
| Active Comparator: Hyaloronan group<br>Patients randomized to this group of treatment will receive 1 blinded knee intra-articular injections of hyaluronic acid (3ml) | Drug: Hyaluronic acid<br>* 3ml hyaluronic acid<br>* Other names: LBSA0103, 60 mg/3ml, LG Life Sciences, Korea;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in International Knee Documentation Committee subjective score at week 24 | International Knee Documentation Committee subjective score for both groups | Baseline, Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in VAS (Visual Analogue scale) for pain during walking | VAS (Visual Analogue scale) for pain during walking for both groups of treatment | Baseline, Week 6, Week 12, Week 24 | 
| Change from baseline in Western Ontario and McMaster Universities Arthritis Index | Western Ontario and McMaster Universities Arthritis Index variation for both groups Subscale analysis of pain, stiffness, function also contain | Baseline, Week 6, Week 12, Week 24 | 
| Number of Participants with Adverse Events | All adverse events included | Week 6, Week 12, Week 24 | 
| Change from baseline in Samsung Medical Center Patellofemoral score (SMC patellofemoral score) | Samsung Medical Center Patellofemoral score for both groups of treatment | Baseline, Week 6, Week 12, Week 24 | 
| Patient global assessment | Patient global assessment was evaluated for improvement of symptoms using 100mm VAS. | Week 6, Week 12, Week 24 | 
| Change from baseline in International Knee Documentation Committee subjective score at week 6, week 12 | International Knee Documentation Committee subjective score for both groups | Baseline, Week 6, Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, platelet-rich plasma, hyaluronic acid