Effect of Bioskin Ten-7 vs. Standard Treatment on Patient Reported Outcomes and Cytokine.

Study Overview
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Brief Summary
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The objectives of the study are 1.) to evaluate pain relief following the application of the Bioskin Ten-7 knee brace and 2.) to determine if use of the Bioskin Ten-7 knee brace is more effective at reducing inflammation than standard of care alone using synovial fluid cytokine analysis and validated outcome measures.

Detailed Description
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Once consented, the patient is assigned to either Group A or Group B. Group A patients will receive standard treatment only and will not be prescribed a knee brace. Group B patients will receive standard treatment and the Bioskin Ten-7 knee brace. On Day 0, the patient will be assigned to one of the 2 groups using a 1:1 assignment. VAS, WOMAC, Oxford Knee Score, KOOS questionnaires will be administered and a sample of the patient's synovial fluid will be sent to labs for cytokine and cell count analysis. All patients will record use of NSAIDs and for Group B, the start and end time of brace use will be recorded. All patients will return in 8 weeks to assess efficacy of treatment. All patients will return their diaries, complete the same validated outcome measures as Day 0 and undergo a repeat synovial fluid analysis.

Official Title
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Effect of Bioskin Ten-7 vs. Standard Treatment on Patient Reported Outcomes and Cytokine.

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Drug: Standard treatment only
* Device: Standard treatment plus Bioskin Ten-7 knee brace


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18 years and older with primary diagnosis of Knee OA with no other knee diagnosis. Must have telephone access. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: Standard Treatment Only<br>Group A will receive standard treatment only such as NSAIDs and injections | Drug: Standard treatment only<br>* Standard treatment such as NSAIDs and injections<br>* Other names: NSAIDs and injections;|
| Experimental: Standard Treatment plus Bioskin Ten-7<br>Group B will receive standard treatment such as NSAIDs and injections and the Bioskin Ten-7 knee brace. | Drug: Standard treatment only<br>* Standard treatment such as NSAIDs and injections<br>* Other names: NSAIDs and injections;Device: Standard treatment plus Bioskin Ten-7 knee brace<br>* Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS - Pain | Value at 8 weeks - value at day 0 | Week 8- Day 0 | 
| KOOS - Symptoms | Value at 8 weeks - value at day 0 | Week 8 - Day 0 | 
| KOOS - ADL | Value at 8 weeks - value at day 0 | week 8 - day 0 | 
| KOOS - Sport/Rec | Value at 8 weeks - value at day 0 | Week 8 - day 0 | 
| KOOS - QOL | Value at 8 weeks - value at day 0 | Week 8 - day 0 | 
| Synovial Fluid Analysis (IL-6) | Interleukine 6 in Synovial fluid analysis | Week 8 - day 0 | 
| Synovial Fluid Analysis (IL-8) | Interleukine 8 in Synovial fluid analysis | Week 8 - day 0 | 
| Synovial Fluid Analysis (TNF-alpha) | Tumor necrosis factor - alpha in Synovial fluid analysis | Week 8 - day 0 | 
| Synovial Fluid Analysis (MIP - 1alpha) | Macrophage Inflammatory Proteins - 1alpha | Week 8 - day 0 | 
| Synovial Fluid Analysis (MCP - 1) | Monocyte chemotactic protein-1 - 1 | Week 8 -day 0 | 
| Oxford Knee Score |  | Day 0 and Week 8 | 
| WOMAC | assess pain, stiffness, and physical function measured by Western Ontario and McMaster universities Osteoarthritis Index | Day 0 and Week 8 | 
| Visual Analog Scale | identifies pain level | Day 0 and Week 8 |