Platelet Rich Plasma on Osteoarthritis of Knee

Study Overview
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Brief Summary
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Although few studies have showed beneficial effect of platelet rich plasma (PRP) for osteoarthritis of knee (OA knee), only one study applied randomized, control method and none of them has the objective measurements such as balance test or muscle strength which were reported as decrease in patients with OA knees. We assess the analgesic effect and the extent of improved muscle strength and balance after PRP in patients with OA knee.

Detailed Description
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Patients with bilateral OA knee will be enrolled and randomized into intervention and control knee. One dose of PRP is applied in the intervention knee and normal saline in control side. Outcome measurements included visual analog scale (VAS)、Lequesne's severity index、Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)、balance test (Biodex) and isokinetic strengthening test at different follow-up frame (2nd week, 1st month, 3rd month and 6th month after treatment).

Official Title
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The Effect of Platelet Rich Plasma on Osteoarthritis of Knee

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Drug: platelet rich plasma
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 35 to 75 y/o. Alert consciousness Symptom of knee osteoarthritis persist at least 6 months and stage I or II scored by Ahlbäck grading system The pain score measured by VAS at least 4 points Exclusion Criteria: Has received hyaluronic acid or steroid injection within 6 monts 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 or muscle strength test.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 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 |
| --- | --- |
| Active Comparator: Platelet rich plasma<br>Platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders. Patients with bilaetral knee osteoarthritis randomized receive on dose of PRP in one knee and placebo with normal saline in the other side. | Drug: platelet rich plasma<br>* Platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders.<br>|
| Placebo Comparator: normal saline<br>Normal saline was injected into the other side of knee as the control group. | Drug: Normal saline<br>* The normal salin as the placebo intervention was injection in the other side of knee.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of pain on 2nd week, 1st month, 3rd month and 6th month after PRP. | Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment. | Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after PRP. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in severity of symptoms and functional status on 2nd week, 1st month, 3rd month and 6th month after treatment. | Using the Lequesne's severity index to measure the symptoms and functional status before treatment and multiple time frame after treatment. | Pre-treatment, on 2nd week, 1st month, 3rd month and 6th month after treatment.. | 
| Change from baseline in severity of symptoms and functional status on 2nd week, 1st month, 3rd month and 6th month after treatment. | 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. | Pre-treatment and 2nd week, 1st month, 3rd month and 6th month after treatment. | 
| Change from baseline in balance function on 2nd week, 1st month, 3rd month and 6th month after treatment. | Using the balance test (Biodex) to measure the balance function before treatment and multiple time frame after treatment. | Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after treatment. | 
| Change from baseline in muscle strength of lower extremities on 2nd week, 1st month, 3rd month and 6th month after treatment. | Using the isokinetic strengthening test to measure the muscle strength of lower extremities before treatment and multiple time frame after treatment. | Pre-treatment, 2nd week, 1st month, 3rd month and 6th month after treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet rich plasma, Osteoarthritis of knee, Balance, Strength