The Role of Synovitis in Osteoarthritis

Study Overview
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Brief Summary
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To determine whether platelet-rich-plasma (PRP) or HA (hyaluronic acid)injection into synovitis in osteoarthritis(OA) knee can achieve improvement in knee function and reduce synovitis.

Detailed Description
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Methods: sixty patients with OA knee having unilateral or bilateral synovitis validated by ultrasound (N=40) were studied. All the patients were randomized to receive PRP (N=40) or Hyaluronic acid(HA)(N=40) injection twice at 2-week intervals; Clinical assessments were performed using a visual analog scale(VAS) and The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index) before injection at baseline, 4 weeks(first evaluation) and 12 weeks(secondary evaluation). Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed simultaneously.

Official Title
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Does Synovitis Affect Treatment Efficacy in Intra-articular Injection Therapy to Osteoarthritis

Conditions
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Synovitis of Knee, Osteoarthritis, Knee

Intervention / Treatment
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* Drug: platelet rich plasma
* Drug: Hyaluronic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed with OA knee according to ACR guideline stiffness less than 30min cracking sound during activity more than 30min pain for last 2 months non-bed ridden patients no structure abnormality synovitis was proved by US Exclusion Criteria: 1. OA knee secondary to other disease 2 . more than 10 years after diagnosing OA 3. under knee surgery within 3 months 4. autoimmune disease 5. refuses inform/consent process

Ages Eligible for Study
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Minimum Age: 45 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP group<br>the patients received PRP(platelet-rich-plasma) injection twice at 2-week intervals | Drug: platelet rich plasma<br>* The amount of PPR was about 4-5 cc<br>|
| Active Comparator: HA group<br>the patients received HA(hyaluronic acid) injection twice at 2-week intervals | Drug: Hyaluronic acid<br>* HA was 2.5cc<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analog scale(VAS) |  | before injection at baseline | 
| visual analog scale(VAS) |  | 4 weeks(first evaluation) | 
| visual analog scale(VAS) |  | 12 weeks(secondary evaluation) | 
| The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index) |  | before injection at baseline | 
| The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index) |  | 4 weeks(first evaluation) | 
| The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC index) |  | 12 weeks(secondary evaluation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed simultaneously. |  | before injection at baseline | 
| Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed |  | 4 weeks(first evaluation) | 
| Imaging evaluation based on color Doppler ultrasound(CDUS) and the depth of synovial fluid accumulation ,and the width of synovial hypertrophy was performed |  | 12 weeks(secondary evaluation) |