The Combination Effect of Platelet-rich Plasma and Hyaluronic Acid for Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
Although platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for osteoarthritis of knee (OA knee), the combined effect of PRP with HA was not clear so far. Hence, investigator assess a prospective randomized double-blind controlled trial.

Detailed Description
-----------------
Patients with single or bilateral OA knee will be enrolled and randomized into intervention and control group. One dose of PRP is applied into both groups. One week later, one dose of HA is injected in intervention group and one dose of normal saline is injected in control group. Outcome measurements included visual analog scale (VAS)、Lequesne's severity index、Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)、balance test (Biodex) and analysis of synovial fluid at different follow-up frame (1st month, 3rd month, 6th month and 1 year after treatment).

Official Title
-----------------
The Combination Long-term Effect of Platelet-rich Plasma and Hyaluronic Acid in Patients With Knee Osteoarthritis: a Prospective Randomized Double-blind Controlled Trial

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

Intervention / Treatment
-----------------
* Drug: platelet rich plasma + Hyaluronic acid
* Drug: platelet rich plasma + normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 50 to 75 y/o. Alert consciousness Symptom of knee osteoarthritis persist at least 6 months and stage I to III scored by Ahlbäck grading system The pain score measured by VAS at least 4 points Exclusion Criteria: Has received hyaluronic acid, PRP or steroid injection within 6 months Has received NSAIDs or steroid within one week Tumor or metastasis surrounding the knee joint Has received total knee replacement, major surgery in knee, rheumatoid arthritis Patient who cant tolerance the balance test. Thrombocytopenia or coagulopathy

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Platelet rich plasma + Hyaluronic acid<br>Platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for patients with osteoarthritis of knee. Patients received one dose of PRP injection. One week later, the one dose of HA is injected for intervention group. | Drug: platelet rich plasma + Hyaluronic acid<br>* Platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for patients with osteoarthritis of knee.<br>|
| Placebo Comparator: Platelet rich plasma + normal saline<br>Patients received one dose of PRP injection. One week later, the one dose of normal saline is injected for control group. | Drug: platelet rich plasma + normal saline<br>* The normal salin as the placebo intervention was injection control group.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in severity of symptoms and functional status on 1st month, 3rd month, 6th month and one year after injection. | Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to measure the symptoms and functional status before treatment and multiple time frame after treatment. Both subscales has the scores ranged from 1 to 5 for each item and a higher score indicating more severe of symptom or impaired functional status. | Pre-treatment, 1st month, 3rd month, 6th month and one year after injection. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in severity of symptoms and functional status on 1st month, 3rd month, 6th month and one year after injection. | Using the Lequesne's severity index to measure the symptoms and functional status before treatment and multiple time frame after treatment. A higher score indicate more severe. | Pre-treatment, 1st month, 3rd month, 6th month and one year after injection. | 
| Change from baseline of pain on 1st month, 3rd month, 6th month and one year after injection. | Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment. The score ranging from 10 (remarkable pain) to 0 (no pain). | Pre-treatment, 1st month, 3rd month, 6th month and one year after injection. | 
| Change from baseline in balance function on 1st month, 3rd month, 6th month and one year after injection. | Using the balance test (Biodex) to measure the balance function before treatment and multiple time frame after treatment. | Pre-treatment, 1st month, 3rd month, 6th month and one year after injection. | 
| Change from baseline in analysis of synovial fluid on 6th month and one year after injection. | The synovial fluid is aspirated to measure the parameters before treatment and multiple time frame after treatment. | Pre-treatment, 6th month and one year after injection. | 

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