Platelet Rich Plasma for Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
This study aimed to analyze the effect of platelet-rich plasma (PRP) on knee osteoarthritis. Eligible patients will undertake arthroscopic knee surgery plus intraoperative PRP and also receive second look surgery and intraoperative biopsy.

Detailed Description
-----------------
Osteoarthritis is a chronic disease defined by progressive degradation of the joint as well as loss of cartilage on joint surfaces. The degeneration that occurs in the joint leads to changes in the catabolic and anabolic activity of chondrocytes. Osteoarthritis may induce pain, stiffness and limitation in range of motion of the joint and also may impact the quality of life. Platelet-rich plasma (PRP) is a fraction of plasma that contains platelets and multiple growth factors concentrated at high level. Because activated platelets have the potential to release growth factors, PRP has been clinically used to accelerate wound healing and tissue regeneration in orthopedic and oral surgery. Although several studies have assessed the effects of PRP on knee osteoarthritis, a higher level of evidence has not been provided. This study aimed to analyze the effect of PRP on knee osteoarthritis. After performing arthroscopic knee surgery plus intraoperative PRP in eligible patients, a second look arthroscopic surgery with intraoperative biopsy will be arranged 6 months later. Pre- and post-operative imaging and clinical outcomes will also be compared.

Official Title
-----------------
Intraoperative Platelet Rich Plasma Injection in Arthroscopic Surgery for Osteoarthritis of the Knee

Conditions
-----------------
Osteo Arthritis Knee, Platelet-rich Plasma

Intervention / Treatment
-----------------
* Other: Platelet-rich plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 30 and 70 years With diagnosis of osteoarthritis, grade II grade IV, II-III medial compartment Exclusion Criteria: Lateral compartment and patellofemoral joint osteoarthritis With prior history of knee surgery Severe varus deformity With current or prior history of traum or infection at the knee With current or prior history of cancer With current or prior history of hematological disease Pregnancy Patients who will not cooperate with one-year followup

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP group<br>Arthroscopic knee surgery plus intraoperative platelet-rich plasma | Other: Platelet-rich plasma<br>* Intraoperative platelet-rich plasma injection during arthroscopic knee surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in knee function from baseline to postoperative 3 months | Knee function is evaluated using Oswestry Disability Index preoperatively and 3-month postoperatively. | 3-month postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in knee function from baseline to postoperative 6 months | Knee function is evaluated using Oswestry Disability Index preoperatively and 6-month postoperatively. | 6-month postoperative | 
| Change in knee function from baseline to postoperative 12 months | Knee function is evaluated using Oswestry Disability Index preoperatively and 12-month postoperatively. | 12-month postoperative | 
| Change in knee pain from baseline to postoperative 3 months | Pain is evaluated using visual analogue scale preoperatively and 3-month postoperatively. | 3-month postoperative | 
| Change in knee pain from baseline to postoperative 6 months | Pain is evaluated using visual analogue scale preoperatively and 6-month postoperatively. | 6-month postoperative | 
| Change in knee pain from baseline to postoperative 12 months | Pain is evaluated using visual analogue scale preoperatively and 12-month postoperatively. | 12-month postoperative | 
| Percentage of patients with regenerated cartilage | Cartilage regeneration is assessed by pathological biopsy during second look surgery at 12-month postoperative. | 12-month postoperative | 
| Change in cartilage thickness from baseline to postoperative 6 months | Cartilage thickness is assessed by MRI preoperatively and 6-month postoperatively. | 6-month postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Platelet-rich plasma, Osteoarthritis Knee