Measuring Synovial Fluid Components

Study Overview
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Brief Summary
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Participants with grade 3 and 4 knee osteoarthritis will recieve aspiration of synoivial fluid, and then receive either dextrose, hemaotopoietic stem cell, or platelet rich plasma, or no injection. The synovial fluid will be analyzed for changes in components.

Detailed Description
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80 participants with grade 3 and 4 symptomatic knee osteoarthritis, with a visable effusion, will receive aspiration of 3 ml of synovial fluid from the suprapatellar pouch, followed by either injection with 10 mL of 12.5% dextrose, 10 cc hematopoietic stem cells, 10cc PRP, or no injection into the suprapatellar pouch. They will then receive aspiration of 3 ml of synovial fluid at 2 days and either 7 days (for dextrose injected or no injection) or 14 days (stem cell and PRP injected) days post injection. These synovial samples will be analyzed for a change in components.

Official Title
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Measuring Synovial Fluid Components

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Diagnostic Test: Measuring synovial fluid components


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:≥ 6 months of knee pain with walking ≥ 6/10 on a 0-10 point numerical rating scale High grade medial compartment cartilage loss ( Kellgren-Lawrence grade 3 or 4) on plain weight bearing X-ray Exposed subchondral bone at 110 degrees of flexion by ultrasound examination Easily visible suprapatellar pouch with quads conttraction. Exclusion Criteria Current intake of NSAIDs or steroids Current anticoagulation therapy Inflammatory or post-infectious knee artthritis Systemic inflammatory conditions Knee flexion less than 100 degrees Knee extension less than 165 degrees Valgus or varus more than 15 degrees Any knee injection in the precedign 3 months BMI more than 50 kg/ meter squared Gross synovial folds on ultrasound.. Elevation of sed rate, C-reactive protein, rheumatoid fractor, or antinuclea antibody.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Consecutive patients treated for knee osteoathritis with dextrose injection, hemaopoietic stem cell injection, PRP injection, or no injection.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dextrose injection<br>Injection of 10 ml of 12.5% dextrose | Diagnostic Test: Measuring synovial fluid components<br>* Using speialized techniques to measure S.F. components<br>|
| Active Comparator: Hematopoietic stem cells<br>Injection of 10 ml of of 7.5 ml hematopoietic stem cells, 2 ml of 25% dextrose (5% diluted), 0.5 ml of 1% lidocaine (0.05% diluted),and 0.25 ml dexamethasone (1.5 mg) | Diagnostic Test: Measuring synovial fluid components<br>* Using speialized techniques to measure S.F. components<br>|
| Active Comparator: Platelet Rich Plasma injection<br>Injection of 10 ml of leukocyte rich platelet rich plasma | Diagnostic Test: Measuring synovial fluid components<br>* Using speialized techniques to measure S.F. components<br>|
| Active Comparator: No injection<br>Aspiration of synovial fluid may be an active comparator. | Diagnostic Test: Measuring synovial fluid components<br>* Using speialized techniques to measure S.F. components<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of unspecified components of synovial fluid (Unspecified due to proprietary reasons) | Change in level of unspecified synovial fluid components from Day 0 to Day 14 | Day 0 to Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) (0-100 scale) Higher scores are a worse outcome. | Change in WOMAC score from Day 0 to Day 14 | Day 0 to Day 14 |